FrancophonIA/ELRC3.0 huggingface dataset:
English: HPV DNA status, cytology and serostatus at baseline.
Maltese: irrispettivament mill-istat tad-DNA ta' HPV, ċitoloġija u l-istat tas-serum fil-linja bażi.
English: Pre-filled syringe EU/1/07/419/004 EU/1/07/419/005 EU/1/07/419/006 EU/1/07/419/007 EU/1/07/419/008 EU/1/07/419/009
Maltese: EU/1/07/419/006 EU/1/07/419/007 EU/1/07/419/008 EU/1/07/419/009
English: Adverse reactions considered as being at least possibly related to vaccination have been categorised by frequency.
Maltese: Reazzjonijiet avversi kkunsidrati li huma possibilment relatati mal-vaċċinazzjoni ġew kategorizzati skond il-frekwenza.
English: The term “premalignant ano-genital lesions” in section 4.1 corresponds to high-grade Cervical Intraepithelial Neoplasia (CIN2/3), high-grade vulvar intraepithelial neoplasia (VIN2/3), high-grade vaginal intraepithelial neoplasia (VaIN2/3) and high-grade anal intraepithelial neoplasia (AIN 2/3).
Maltese: Il-frażi “leżjonijiet ano-ġenitali fi stadju ta' qabel il-kanċer” f'sezzjoni 4.1 tikkorrispondi għal Neoplażja ta' grad għoli Ġewwa ċ-ċellula tal-Epitelju tal-Għonq tal-Utru (CIN2/3), neoplażja ta' grad għoli ġewwa ċ-ċellula tal-epitelju tal-vulva (VIN2/3), neoplażja ta' grad għoli ġewwa ċ-ċellula tal epitelju tal-vaġina (VaIN2/3) u neoplażja ta' grad għoli ġewwa ċ-ċellula tal-epitelju anali (AIN 2/3).
English: GlaxoSmithKline d.o.o.
Maltese: GlaxoSmithKline d.o.o. Tel.:
English: 6-month persistent infection
Maltese: Infezzjoni persistenti għal 6
English: The proportion of subjects reaching anti-HBs ≥ 10mIU/ml was 98.3% for concomitant vaccination and 100% for Twinrix given alone.
Maltese: Il-proporzjon ta' individwi li laħqu anti-HBs ≥ 10mIU/ml kien 98.3% għal vaċċinazzjoni fl-istess ħin u 100% għal Twinrix mogħti waħdu.
English: HPV-16 and HPV-18 are estimated to be responsible for approximately 70% of cervical cancers, 90% of anal cancers, 70% of HPV-related high grade vulvar and vaginal intraepithelial neoplasia and 78% of HPV related high-grade anal (AIN 2/3) intraepithelial neoplasia.
Maltese: HPV-16 u HPV-18 huma stmati li huma responsabbli għal bejn wieħed u ieħor 70% ta' kanċer flgħonq tal-utru, 90% ta' kanċer anali, 70% ta' neoplażja ta' grad għoli ġewwa ċ-ċellula tal-epitelju talvulva u tal-vaġina marbuta ma' HPV u 78% ta' neoplażja ta' grad għoli ġewwa ċ-ċellula tal-epitelju anali relatata ma' HPV (AIN 2/3).
English: HPV-16/18 endpoint
Maltese: HPV-16/18 (TVC) Endpoint HPV
English: Similar results were observed when Cervarix was given concomitantly with Engerix B with 97.9% of subjects reaching anti-HBs ≥ 10mIU/ml compared to 100% for Engerix B given alone.
Maltese: Riżultati jixxiebhu kienu osservati meta Cervarix ingħata flimkien ma' Engerix B b'97.9% tal-individwi jilħqu anti-HBs ≥ 10mIU/ml meta mqabbel ma' 100% għal Engerix B mogħti waħdu.
English: 1 ml of suspension in a vial (type I glass) for 2 doses with a stopper (rubber butyl).
Maltese: 1 ml suspensjoni f'kunjett (tip I tal-ħġieġ) għal 2 dożi b'tapp (butyl rubber).
English: However, stability has been demonstrated when stored outside the refrigerator for up to 3 days at temperatures between 8°C and 25°C or for up to 1 day at temperatures between 25°C and 37°C.
Maltese: Madankollu, , l-istabilità intweriet sa 3 ijiem meta maħżun barra mill-friġġ f'temperaturi bejn 8˚C u 25˚C jew sa ġurnata f'temperaturi bejn 25˚C u 37˚C.
English: How to store Cervarix
Maltese: X'fih Cervarix
English: Tel: + 386 (0) 1 280 25 00 medical.x.si@gsk.com
Maltese: GlaxoSmithKline d.o.o. Tel: + 386 (0) 1 280 25 00 medical.x.si@gsk.com
English: Cervarix is intended for use from 9 years of age onwards.
Maltese: Cervarix huwa intenzjonat għall-użu minn 9 snin 'l fuq.
English: CIN3+ TVC-naïve(1)
Maltese: Ġodda għal TVC (1)
English: Very common Myalgia Common
Maltese: Komuni ħafna Majalġja
English: In the placebo group, there were 4 cases of 6-month persistent infection and 1 case of 12-month persistent infection.
Maltese: Fil-grupp tal-plaċebo, kien hemm 4 każijiet ta' infezzjoni persistenti ta' 6 xhur u każ 1 ta' infezzjoni persistenti ta' 12-il xahar.
English: The GMTs appeared to be lower in the HIV infected group (non overlapping 95% confidence interval).
Maltese: Il-GMTs dehru li kienu aktar baxxi fil-grupp infettat bl-HIV (intervall ta' kunfidenza li ma jikkoinċidix ta' 95%).
English: Pre-filled syringe
Maltese: Tapp tas-siringa
English: Prophylactic efficacy against HPV-16/18 in women naïve to HPV-16 and/or HPV-18
Maltese: HPV-16/18 f'nisa inġenwi għal HPV-16 u/jew HPV-18
English: EU/1/07/419/008 - pack of 1 without needle EU/1/07/419/009 - pack of 10 without needle EU/1/07/419/004 - pack of 1 with 1 needle EU/1/07/419/006 - pack of 10 with 10 needles EU/1/07/419/005 - pack of 1 with 2 needles EU/1/07/419/007 - pack of 10 with 20 needles
Maltese: EU/1/07/419/006 - pakkett ta' 10 b'10 labriet EU/1/07/419/005 - pakkett ta' 1 b'2 labriet EU/1/07/419/007 - pakkett ta' 10 b'20 labra
English: It is important that procedures are in place to avoid injury from faints.
Maltese: Huwa importanti li jkun hemm proċeduri biex jiġu evitati inċidenti waqt ħass ħażin.
English: In clinical studies that enrolled girls and women aged from 10 up to 72 years (of which 79.2% were aged 10-25 years at the time of enrolment), Cervarix was administered to 16,142 females whilst 13,811 females received control.
Maltese: Fi studji kliniċi, li irreġistraw bniet u nisa minn 10 snin sa 72 sena (li minnhom 79.2% kellhom bejn l10 u l-25 fiż-żmien tar-reġistrazzjoni), Cervarix ingħata lil 16,142 mara filwaqt li 13, 811 ingħataw kontroll.
English: The Human Papillomavirus (HPV) types contained in the vaccine (HPV types 16 and 18) are responsible for approximately 70% of cervical cancers, 90% of anal cancers, 70% of HPV-related precancerous lesions of the vulva and vagina and 78% of HPV-related pre-cancerous lesions of the anus.
Maltese: It-tipi ta' Papillomavirus Uman (HPV) li fiha t-tilqima (it-tipi 16 u 18 ta' HPV) huma l-kaġun ta' madwar 70% tal-każi ta' kanċer tal-għonq tal-utru, 90% ta' kanċer anali, 70% tal-feriti ta' qabel il kanċer fil-vulva u fil-vaġina marbuta ma' HPV u 78% ta' leżjonijiet ta' qabel il-kanċer relatati malHPV tal-anus.
English: 9 to and including 14 years* Two doses each of 0.5 ml.
Maltese: 9 sa u inkluż 14-il sena*
English: Cervical Intraepithelial Neoplasia (CIN) grade 2 and 3 (CIN2/3) and cervical adenocarcinoma in situ (AIS) were used in the clinical trials as surrogate markers for cervical cancer.
Maltese: Neoplażja Ġewwa ċ-ċellula tal-Epitelju tal-Għonq tal-Utru (CIN) tal-gradi 2 u 3 (CIN2/3) u adenokarċinoma tal-għonq tal-utru in situ (AIS) intużaw fil-provi kliniċi bħala sostituti ta' markaturi għall-kanċer tal-għonq tal-utru.
English: The antibody response to HPV-16 and HPV-18 was measured using a type-specific direct ELISA (version 2, MedImmune methodology, modified by GSK) which was shown to correlate with the pseudovirion-based neutralisation assay (PBNA).
Maltese: Ir-rispons ta' anti-korpi għal HPV-16 u HPV-18 ġie mkejjel b'ELISA diretta speċifika għat-tip (verżjoni 2, Metodoloġija MedImmune, immodifikata minn GSK) li wera li kkorrelata ma' l-analiżi ta' newtralizzazzjoni ibbażata fuq pseudovirion (PBNA).
English: Syringe cap
Maltese: Jekk taqbeż doża
English: 100 vials 100 x 1 dose (0.5 ml)
Maltese: 100 doża x 1 (0.5 ml)
English: 0.5 milligrams Al3+ in total 4L1 protein in the form of non-infectious virus-like particles (VLPs) produced by recombinant DNA technology using a Baculovirus expression system which uses Hi-5 Rix4446 cells derived from Trichoplusia ni. For the full list of excipients, see section 6.1.
Maltese: 4Proteina L1 f'għamla ta' partiċelli mhux infettivi qishom virus (VLP's) prodotta bl-użu ta' teknoloġija rikombinanti ta' DNA bl-użu ta' sistema ta' espressjoni Baculovirus li tuża ċelluli Hi-5
English: You should continue to follow your doctor's advice on cervical smear/Pap test (test to screen for changes in cells of the cervix caused by an HPV infection) and preventative and protective measures.
Maltese: smear/Pap test u miżuri oħra ta' prevenzjoni u protezzjoni.
English: 92 subjects in the vaccine group had immunogenicity data at the [M107M113] interval after the first vaccine dose with a median follow-up of 8.9 years.
Maltese: 92 individwu fil-grupp tal-vaċċin kellhom dejta ta' immunoġeniċità fl-intervall [M107-M113] wara l-ewwel doża tal-vaċċin fejn l-individwi komplew jiġu segwiti għal medjan ta' 8.9 snin.
English: Syringe plunger
Maltese: Planġer tas-siringa
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIDOSE VIAL, PACK OF 1, 10, 100
Maltese: DOŻI, PAKKETT TA' 1, 10, 100
English: Cross-protective efficacy
Maltese: Effikaċja protettiva inkroċjata
English: The TVC-naïve is a subset of the TVC that includes women with normal cytology, and who were HPV DNA negative for 14 oncogenic HPV types and seronegative for HPV-16 and HPV-18 at baseline.
Maltese: Il-grupp TVC inġenwi huwa sottosett ta' TVC li jiġbor fiħ nisa b'ċitloloġija normali, li kienu negattivi għad-DNA ta' HPV għal 14-il tip onkoġeniku ta' HPV u seronegattivi għal HPV-16 u HPV-18 fillinja bażi.
English: In two clinical studies that enrolled males aged 10 to 18 years, 2,617 males received Cervarix and were followed-up with active safety surveillance.
Maltese: 10 snin sa 18-il sena, 2,617-il raġel irċevew Cervarix u ġew segwiti b'sorveljanza tas-sigurtà attiva.
English: 58, 59, 66 and 68 - Were seronegative for HPV-16 and HPV-18 and - Had normal cytology
Maltese: 45, 51, 52, 56, 58, 59, 66 u 68 - Kienu seronegattivi għal HPV-16 u HPV-18 u
English: 6M PI and/or CIN1+ 6M PI
Maltese: 6 xhur relatata ma' HPV 16/18 u/jew CIN1+.
English: (3) mean follow-up of 40 months post dose 3
Maltese: (3) medja ta' segwitu ta' 40 xahar wara doża 3
English: QUALITATIVE AND QUANTITATIVE COMPOSITION 1 dose (0.5 ml) contains:
Maltese: U KWANTITATTIVA Doża waħda (0.5 ml) ikun fiha:
English: 100 multidose vials 100 x 2 doses (1 ml)
Maltese: 100 kunjett b'ħafna dożi 100 x 2 dożi (1 ml)
English: 10 vials 10 x 1 dose (0.5 ml)
Maltese: 10 dożi x 1 (0.5 ml)
English: Turbid white suspension.
Maltese: Suspensjoni bajda mdardra.
English: The analysis against the primary endpoint was confounded by multiple co-infections in the CIN2+ lesions.
Maltese: L-analiżi kontra l-endpoint primarju kienet mfixkla b'ħafna infezzjonijiet fil-leżjonijiet CIN2+.
English: • dizziness
Maltese: AWTORIZZAZZJONI
English: (NaH2PO4.2 H2O) and water for injections.
Maltese: .2 H2O) u ilma għall-injezzjonijiet.
English: There were sixteen cases of persistent HPV-16 infection, and five cases of persistent HPV-18 infection, all in the control group.
Maltese: Kien hemm sittax il-każ ta' infezzjoni persistenti b'HPV-16, u ħames każijiet ta' infezzjoni persistenti b'HPV-18, kollha fil grupp ta' kontroll.
English: In clinical trials a similar safety profile has been observed in subjects with prior or current HPV infection as compared to subjects negative for oncogenic HPV DNA or seronegative for HPV-16 and HPV-18 antibodies.
Maltese: Fil-provi kliniċi ġie osservat profil ta' sigurtà simili f'suġġetti b'infezzjoni ta' HPV kurrenti jew passata meta mqabbla ma suġġetti negattivi għal HPV DNA onkoġeniku jew seroneggativi għal antibodies għal HPV-16 u HPV-18.
English: This cohort included women with normal or low-grade cytology at baseline and excluded only women with high-grade cytology (0.5% of the total population).
Maltese: Dan il-grupp kien jiġbor fih nisa b'ċitoloġija normali jew ta' grad baxx fil-linja bażi u eskluda biss nisa li kellhom ċitoloġija ta' grad għoli (0.5% tal-popolazzjoni totali).
English: Table 2: Vaccine efficacy against virological endpoints associated with HPV-16/18 (ATP cohort) HPV-16/18 endpoint
Maltese: HPV-16/18 (grupp ATP) Endpoint HPV-16/18
English: At the 84-month time point, i.e. 78 months after completion of the full vaccination course, 99.3% and 95.9% of initially seronegative women remained seropositive for anti-HPV-16 and anti-HPV-18 antibodies, respectively.
Maltese: Fil-punt ta' żmien ta' 84 xahar, jiġifieri 78 xahar wara li tlesta l-kors ta' tilqim kollu, 99.3 % u 95.9 % tan-nisa li fil-bidu kienu seronegattivi baqgħu seropożittivi għall-antikorpi kontra
English: Cervarix is available in 1 dose vials (0.5 ml) in packs of 1, 10 and 100.
Maltese: Cervarix tista' ssibu f'kunjetti ta' doża waħda (0.5 ml) f'kaxxi ta' 1, 10 u 100.
English: A similar kinetic profile was observed with the neutralising antibodies.
Maltese: Profil kinetiku jixxiebah kien osservat bl-antikorpi li jinnewtralizzaw.
English: Cervarix can be given with a combined booster vaccine containing diphtheria (d), tetanus (T) and pertussis [acellular] (pa) with or without inactivated poliomyelitis (IPV), (dTpa, dTpa -IPV vaccines), with a combined hepatitis A and hepatitis B vaccine (Twinrix) or a hepatitis B vaccine (Engerix B), or with a meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate vaccine (MenACWY-TT), at a separate injection site (another part of your body, e.g. the other arm) during the same visit.
Maltese: Cervarix jista' jingħata flimkien ma' vaċċin booster li fih taħlita ta' difterite (d), tetnu (T) u sogħla konvulsiva [aċellulari] (pa) flimkien ma jew mingħajr poljomelite inattivat (IPV), (vaċċini dTpa, dTpa-IPV), ma' vaċċin li fih taħlita tal-epatite A u l-epatite B (Twinrix) jew vaċċin tal-epatite B
English: Suspension for injection 1 multidose vial 2 doses (1 ml)
Maltese: Suspensjoni għall-injezzjoni Kunjett b'ħafna dożi wieħed 2 dożi (1 ml)
English: Based on the HPV type assignment post-hoc analysis, there was 1 CIN2+ case in the vaccine group versus 92 cases in the control group (Efficacy 98.9% (95% CI: 93.8;100)) and no CIN3+ case in the vaccine group versus 22 cases in the control group (Efficacy 100% (95% CI: 81.8;100)) at the end of study analysis.
Maltese: Fuq bażi tal-analiżi post-hoc tal-assenjazzjoni tat-tip ta' HPV, kien hemm każ wieħed ta' CIN2+ filgrupp tat-tilqima versus 92 każ fil-grupp ta' kontroll (Effikaċja 98.9% (95% CI: 93.8; 100)) u l-ebda każ ta' CIN3+ fil-grupp tat-tilqima versus 22 każ fil-grupp ta' kontroll (Effikaċja 100% (95% CI: 81.
English: Nederland GlaxoSmithKline BV
Maltese: GlaxoSmithKline Lietuva UAB
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially “sodiumfree”.
Maltese: Dan il-prodott mediċinali fih anqas minn 1 mmol ta' sodium (23 mg) għal kull doża, jiġifieri hu essenzjalment “ħieles mis-sodium”.
English: N = number of subjects included in each group n = number of cases (1) ATP: includes women who received 3 doses of vaccine, were DNA negative and seronegative at month 0 and DNA negative at month 6 to the relevant HPV type (HPV-16 or HPV-18) (2) including 4 cases of CIN2+ and 2 cases of CIN3+ in which another oncogenic HPV type was identified in the lesion, concomitantly with HPV-16 or HPV-18.
Maltese: (2) inkluż 3 każijiet ta' CIN2+ u 2 każijiet ta' CIN3+ fejn fil-leżjoni kien identifikat tip onkoġeniku ieħor ta' HPV, flimkien ma' HPV-16 jew HPV-18.
English: As a precautionary measure, it is preferable to avoid the use of Cervarix during pregnancy.
Maltese: Bħala miżura ta' prekawzjoni, huwa preferibbli li l-użu ta' Cervarix jiġi evitat waqt it-tqala.
English: HPV-16 related types (A9 species) HPV-31 HPV-33 HPV-35 HPV-52 HPV-58 HPV-18 related types (A7 species) HPV-39 HPV-45 HPV-59 HPV-68 Other types HPV-51 HPV-56 HPV-66 n= number of cases (1) ATP: includes women who received 3 doses of vaccine, were DNA negative at month 0 and at month 6 to the relevant HPV type.
Maltese: Fil-provi kliniċi (HPV-070 u HPV-048) imwettqa fuq bniet ta' bejn 9 u 14-il sena li rċevew skeda f'żewġ dożi (0, 6 xhur jew 0, 12-il xahar) u nisa żgħażagħ ta' bejn 15-25 sena li rċevew Cervarix skont l-iskeda standard ta' 0, 1, 6 xhur, il-persuni kollha kellhom serokonverżjoni kemm għall-HPV tat-tip
English: Except for asymptomatic human immunodeficiency virus (HIV) infected subjects for whom limited immunogenicity data are available (see section 5.1), there are no data on the use of Cervarix in subjects with impaired immune responsiveness such as patients receiving immunosuppressive treatment.
Maltese: Ħlief għal individwi infettati bil-virus tal-immunodefiċjenza umana (HIV) mingħajr ebda sintomu li għalihom id-dejta disponibbli dwar l-immunoġeniċità hija limitata (ara sezzjoni 5.1), ma jeżistix tagħrif dwar l-użu ta' Cervarix f'suġġetti b'indeboliment tar-rispons immunitarju bħal pazjenti fuq kura immunosoppressiva.
English: ГлаксоСмитКлайн ЕООД Тел.
Maltese: България ГлаксоСмитКлайн ЕООД
English: CIN2+ 1/1,852 6/1,818
Maltese: 6M PI u/jew CIN1+ 6M PI CIN2+ 1/1,852 6/1,818 ASC-US+ 3/1,852 47/1,818 6M PI f'individwi seropożittivi fil-linja bażi biss
English: A subset of women (N=776) vaccinated in study 001 was followed in study 007 up to 6.4 years (approximately 77 months) after the first dose (mean follow-up of 5.9 years).
Maltese: Grupp sekondarju ta' nisa (N=776) vaċċinati fi studju 001 ġie segwit fi studu 007 sa 6.4 snin
English: Not known* Lymphadenopathy
Maltese: 4.1 Indikazzjonijiet terapewtiċi
English: Table 4: Vaccine efficacy against virological endpoints associated with HPV-16/18 (TVC)
Maltese: Tabella 4: L-effikaċja tat-tilqima kontra endpoints viroloġiċi marbuta ma' HPV-16/18 (TVC)
English: Final analysis was performed at study conclusion, 7 years after 1st vaccination.
Maltese: Saret analiżi finali filkonklużjoni tal-istudju, 7 snin wara l-1el vaċċinazzjoni.
English: In study 023 (a subset of study 001/007), the immune response continued to be evaluated up to 113 months.
Maltese: Fl-istudju 023 (sottosett tal-istudju 001/007), ir-rispons immuni kompla jiġi evalwat sa 113 xahar.
English: Vaccine-induced IgG GMTs for both HPV-16 and HPV-18 peaked at month 7 and then declined to reach a plateau from month 18 up to the [M107-M113] interval with ELISA GMTs for both HPV-16 and HPV-18 at least still 10-fold higher than the ELISA GMTs observed in women who cleared a natural HPV infection.
Maltese: IgG GMTs ikkawżati mill-vaċċin kemm għall-HPV-16 kif ukoll għall-HPV-18 laħqu l-ogħla livelli tagħhom fis-seba' xahar u mbagħad bdew jonqsu sa ma laħqu plateau mit-18-il xahar sal-intervall [M107-M113] fejn il-GMTs b'ELISA kemm għall-HPV-16 kif ukoll għall-HPV-18 li kienu għadhom mill-inqas 10 darbiet aktar mill-GMTs b'ELISA osservati f'nisa li fiequ minn infezzjoni naturali b'HPV.
English: Multidose vial EU/1/07/419/010 EU/1/07/419/011 EU/1/07/419/012
Maltese: EU/1/07/419/011 EU/1/07/419/012
English: N = number of subjects included in each group n = number of cases (1) TVC: includes all vaccinated subjects (who received at least one dose of vaccine) irrespective of
Maltese: N = numru ta' individwi inklużi f'kull grupp n = numru ta' każijiet (1) TVC: jinkludi l-individwi li tlaqqmu kollha (li rċevew mill-anqas doża waħda tat-tilqima)
English: It is recommended that subjects who receive a first dose of Cervarix complete the vaccination course with Cervarix (see section 4.4).
Maltese: Hu rrakkomandat li suġġetti li jirċievu l-ewwel doża ta' Cervarix jispiċċaw il-kors ta' tilqim b'Cervarix (ara sezzjoni 4.4).
English: Vaccine efficacy against the primary endpoint CIN2+at the end of study is presented in Table 1.
Maltese: L-effikaċja tat-tilqima kontra l-endpoint primarju CIN2+ fl-aħħar tal-istudju hija ppreżentata f'Tabella 1.
English: Duration of protection has not fully been established.
Maltese: It-tul tal-prevenzjoni ma ġiex stabbilit kompletament.
English: EU/1/07/419/012 - pack of 100
Maltese: EU/1/07/419/011 - pakkett ta' 10 EU/1/07/419/012 - pakkett ta' 100
English: CIN2+ associated with HPV-16 and HPV-18 individually was demonstrated.
Maltese: HPV-16 u HPV-18, rispettivament.
English: Not known* Allergic reactions (including anaphylactic and anaphylactoid reactions), angioedema
Maltese: Reazzjonijiet allerġiċi (inklużi reazzjonijiet anafilattiċi u dawk li jixbħu r-reazzjonijiet anafilattiċi), anġjoedema
English: Vaccine efficacy against virological endpoints (6-month and 12-month persistent infection) associated with HPV-16/18 observed in TVC at end of study is presented in Table 4.
Maltese: L-effikaċja tat-tilqima kontra endpoints viroloġiċi (infezzjoni persistenti għal 6 xhur u 12-il xahar) marbuta ma' HPV-16/18 osservata f'TVC fl-aħħar tal-istudju hija ppreżentata f'Tabella 4.
English: Persistent infection that lasts for at least 6 months has also been shown to be a relevant surrogate marker for cervical cancer in women aged 15 to 25 years.
Maltese: Infezzjoni persistenti li ddum għal mill-anqas 6 xhur intweriet li kienet ukoll markatur ta' sostituzzjoni rilevanti għall-kanċer tal-għonq tal-utru f'nisa b'età minn 15 sa 25 sena.
English: 10 multidose vials 10 x 2 doses (1 ml)
Maltese: 10 kunjetti b'ħafna dożi 10 x 2 dożi (1 ml)
English: Pregnancy, breast-feeding and fertility
Maltese: Mhux disponibbli dejta dwar il-fertilità
English: The need for a booster dose has not been established (see section 5.1).
Maltese: Il-ħtieġa ta' doża booster ma ġietx stabbilita (ara s-sezzjoni 5.1).
English: Suomi/Finland GlaxoSmithKline Oy Puh/Tel: + 358 10 30 30 30 Finland.tuoteinfo@gsk.com
Maltese: + 358 10 30 30 30 Finland.tuoteinfo@gsk.com
English: GlaxoSmithKline Lietuva UAB Tel: +370 5 264 90 00 info.lt@gsk.com
Maltese: Tel: +370 5 264 90 00 info.lt@gsk.com
English: The immunogenicity induced by three doses of Cervarix has been evaluated in 5,465 female subjects from 9 to 55 years of age and over 800 male subjects aged 10 to 18 years.
Maltese: ta' 9 snin sa 55 sena u aktar minn 800 individwu raġel mill-età ta' 10 snin sa 18-il sena.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, acute and repeated dose toxicity, local tolerance, fertility, embryo-foetal and postnatal toxicity (up to the end of the lactation period).
Maltese: Tagħrif mhux kliniku ibbażat fuq studji konvenzjonali ta' sigurtà farmakoloġika, effett tossiku akut u minn dożi ripetuti, tolleranza lokali, fertilità, effett tossiku fuq l-embriju/fetu u wara t-twelid (sa tmiem il-perjodu tat-treddigħ), ma juri l-ebda periklu speċjali għall-bnedmin.
English: The clinical relevance of this observation is not known.
Maltese: Mhux magħruf kemm din l-osservazzjoni hija klinikament rilevanti.
English: Data in pregnant women collected as part of pregnancy registries, epidemiological studies and inadvertent exposure during clinical trials are insufficient to conclude whether or not vaccination with Cervarix affects the risk of adverse pregnancy outcomes including spontaneous abortion.
Maltese: Dejta fuq nisa tqal miġbura bħala parti mirreġistri tat-tqala, minn studji epidemijoloġiċi u minn espożizzjoni involontarja waqt provi kliniċi mhijiex biżżejjed biex tinstilet konklużjoni dwar jekk tilqima b'Cervarix taffettwax ir-riskju ta' eżiti avversi fit-tqala inkluż abort spontanju.
English: Suspension for injection
Maltese: Suspensjoni għall-injezzjoni
English: The efficacy of Cervarix was assessed in two controlled, double-blind, randomised Phase II and III clinical trials that included a total of 19,778 women aged 15 to 25 years.
Maltese: L-effikaċja ta' Cervarix ġiet assessjata f'żewġ studji tal-Fażijiet II u III randomised, double-blind, u kontrollati (HPV-001/007 and HPV-008) li kienu jinkludu total ta' 19,778 nisa ta' bejn il- 15 u l- 25 sena.
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' ħafna sinjali newroloġiċi oħra bħal disturbi transitorji fil-vista, paresteżija u ċaqliq toniku-kloniku tar-riġlejn waqt l-irkupru.
English: HPV 45, -31 and -33 are the 3 most common non-vaccine HPV types identified in squamous cervical carcinoma (12.1%) and adenocarcinoma (8.5%).
Maltese: HPV-45, -31 u -33 huma l-aktar 3 tipi komuni ta' HPV li mhumiex fil-vaċċin identifikati f'karċinoma taċ-ċelluli squamous tal-għonq tal-utru(12.
English: Cervarix contains sodium chloride.
Maltese: Ceravarix fih is-sodium chloride
English: EU/1/07/419/003 - pack of 100
Maltese: EU/1/07/419/002 - pakkett ta' 10 EU/1/07/419/003 - pakkett ta' 100