FrancophonIA/ELRC3.0 huggingface dataset:
English: The CHMP reviewed all available data from pre-clinical and clinical studies, literature and post-marketing experience on aneuploidy for TCC containing medicinal products for systemic use.
Maltese: Is-CHMP irreveda d-dejta kollha disponibbli minn studji pre-kliniċi u kliniċi, mil-letteratura u l-esperjenza wara tqegħid fis-suq dwar anewplojdija għal prodotti mediċinali li fihom TCC għall-użu sistemiku.
English: • Carcinogenicity and impaired fertility are categorised as important potential risks.Concerning the risk of male infertility: elevated sperm chromosome aneuploidy is known to be associated with male infertility.
Maltese: • Il-karċinoġeniċità u indeboliment fil-fertilità huma kategorizzati bħala riskji potenzjali importanti.
English: The preclinical development of TCC was mainly performed during the 1980s, and then complemented in the 1990s to be compliant with the European guidelines on the non-clinical documentation for mixed marketing authorisation applications (CPMP/SWP/799/95) and to investigate a new active metabolite SL18.0740 (M1) identified at that time.
Maltese: L-iżvilupp prekliniku ta' TCC kien prinċipalment sar matul it-tmeninijiet, u mbagħad ġie kkumplimentat fid-disgħinijiet biex ikun konformi mal-linji gwida Ewropej dwar id-dokumentazzjoni mhux klinika għal applikazzjonijiet għall-awtorizzazzjoni għat-tqegħid fis-suq imħallta (CPMP/SWP/799/95) u biex jiġi investigat metabolit attiv ġdid SL18.0740 (M1) identifikat dak iż-żmien.
English: Having noted the above, the CHMP concluded that the benefit-risk balance of TCC containing medicinal products indicated as adjuvant treatment of painful muscle contractures in acute spinal pathology in adults and adolescents from 16 years onwards remains favourable subject to the restrictions, warnings, other changes to the product information, additional pharmacovigilance activities and RMMs agreed.
Maltese: Wara li nnota dan ta' hawn fuq, is-CHMP ikkonkluda li l-bilanċ tal-benefiċċju-riskju ta' prodotti mediċinali li fihom TCC indikati bħala kura aġġuvanti ta' kontrazzjonijiet muskolari li jikkawżaw l-uġigħ f'patoloġija spinali akuta f'adulti u adolexxenti ta' aktar minn 16-il sena jibqa favorevoli soġġett għar-restrizzjonijiet, twissijiet, tibdil ieħor lill-informazzjoni dwar il-prodott, attivitajiet addizzjonali ta' farmakoviġilanza u RMMs miftiehma.
English: • Firstly, since the TCC metabolite M2 has been shown to be aneugenic at exposure levels close to human therapeutic exposure, the CHMP considered that the dose should be restricted (to 8 mg bid PO and 4 mg bid by IM) and long-term use avoided.
Maltese: • L-ewwel nett, peress li l-metabolit M2 ta' TCC intwera li huwa anewġeniku f'livelli ta' esponiment qrib l-esponiment terapewtiku tal-bniedem, is-CHMP qies li d-doża għandha tiġi ristretta (għal 8 mg darbtejn kuljum mill-ħalq u 4 mg darbtejn kuljum ġol-muskoli) u jiġi evitat l-użu fit-tul.
English: To address the risks of teratogenicity and embryo-toxicity/spontaneous abortions the CHMP agreed on contraindicating TCC during the entire pregnancy period, during lactation, and in women of childbearing potential not using contraception.
Maltese: Biex jiġu indirizzati r-riskji ta' teratoġeniċità u tossiċità tal-embriju/aborti spontanji s-CHMP qabel dwar il-kontraindikazzjoni ta' TCC matul il-perjodu sħiħ tat-tqala, matul it-treddigħ, u f'nisa li jistgħu joħorġu tqal li ma jkunux qed jużaw kontraċezzjoni.
English: Overall summary of the scientific evaluation of thiocolchicoside containing medicinal products for systemic use (see Annex I)
Maltese: Sommarju ġenerali tal-valutazzjoni xjentifika ta' prodotti mediċinali li fihom thiocolchicoside għall-użu sistemiku (ara Anness I)
English: The in vitro MN test in human lymphocytes showed that M2 induced micronuclei in cultured human peripheral blood lymphocytes in all treatment conditions.
Maltese: It-test in vitro tal-MN fil-limfoċiti umani wera li l-M2 induċa l-mikronukleji f'limfoċiti kkultivati umani periferali tad-demm fil-kundizzjonijiet kollha ta' kura.
English: • The Committee considered that thiocolchicoside containing medicinal products for systemic use remain an effective adjuvant treatment of painful muscle contractures in acute spinal pathology.
Maltese: • Il-Kumitat qies li prodotti mediċinali li fihom thiocolchicoside għall-użu sistemiku jibqgħu kura aġġuvanti effettiva għal kontrazzjonijiet muskolari li jikkawżaw l-uġigħ f'patoloġija spinali akuta.
English: However, having considered the risks, thiocolchicoside containing medicinal products for systemic use should only be administered to patients over 16 years of age in acute conditions, with treatment duration limited to 7 (oral) and 5 (IM) consecutive days.
Maltese: Madankollu, wara li qies ir-riskji, prodotti mediċinali li fihom thiocolchicoside għall-użu sistemiku għandhom jingħataw biss lil pazjenti li għandhom aktar minn 16-il sena f'kundizzjonijiet akuti, u t-tul tal-kura għandu jiġi limitat għal 7 ijiem (orali) u 5 ijiem (ġol-muskoli) konsekuttivi.
English: The Committee, as consequence, concluded that the benefit-risk balance of thiocolchicoside containing medicinal products for systemic use as adjuvant treatment of painful muscle contractures in acute spinal pathology in adults and adolescents from 16 years onwardsremains favourable, subject to the restrictions, warnings, other changes to the product information, additional pharmacovigilance activities and risk minimisation measures agreed.
Maltese: Bħala konsegwenza, il-Kumitat ikkonkluda li l-bilanċ tal-benefiċċju-riskju ta' prodotti mediċinali li fihom thiocolchicoside għall-użu sistemiku bħala kura aġġuvanti ta' kontrazzjonijiet muskolari li jikkawżaw luġigħ f'patoloġija spinali akuta f'adulti u adolexxenti minn 16-il sena ‘l fuq jibqa favorevoli soġġett għarrestrizzjonijiet, twissijiet, tibdil ieħor lill-informazzjoni dwar il-prodott, attivitajiet addizzjonali ta' farmakoviġilanza u RMMs miftiehma.
English: The CHMP was therefore of the view that the available data allow to confirm a clear aneugenic effect of the thiocolchicoside metabolite M2 at concentrations which are 4 fold the human exposure in plasma after oral 8 mg TCC treatment bid (recommended dose) and starting from 25 mg/kg dose.The submitted data did not allow establishing a NOEL for aneuploidy, thus not excluding the potential for a human risk.
Maltese: Għalhekk is-CHMP kien tal-fehma li d-dejta disponibbli tippermetti konferma ta' effett anewġeniku ċar tal-metabolit M2 ta' thiocolchicoside f'konċentrazzjonijiet ta' 4 darbiet ogħla millesponiment fil-bniedem fil-plasma wara kura orali b'TCC ta' 8 mg darbtejn kuljum (doża rakkomandata) u li tibda minn doża ta' 25 mg/kg.
English: After discontinuation by a Company of a phase I clinical trial with TCC because of new non-clinical findings, the Italian medicines agency (AIFA) requested one of the Marketing Authorisation Holders (MAH) of TCC to further investigate the genotoxic potential of TCC and in particular of its metabolites; the MAH was requested to perform in vivo and in vitro preclinical studies to address the potential genotoxicity of the metabolites of TCC.
Maltese: Wara li Kumpanija waqqfet prova klinika tal-fażi I b'TCC minħabba sejbiet ġodda mhux kliniċi, l-aġenzija tal-mediċini Taljana (AIFA) talbet lil wieħed mid-Detenturi tal-Awtorizzazzjoni għat-Tqegħid fis-Suq (MAH) ta' TCC biex ikompli jinvestiga l-potenzjal ġenotossiku ta' TCC u b'mod partikolari tal-metaboliti tiegħu; lMAH intalab iwettaq studji prekliniċi in vivo u in vitro biex tiġi indirizzata l-ġenotossiċità potenzjali talmetaboliti ta' TCC.
English: In conclusion, the results of the above pre-clinical studies showed that M2 (SL59.0955) induced micronuclei in vitro and in vivo, generated via a predominantly aneugenic mechanism under all treatment conditions.
Maltese: Bħala konklużjoni, ir-riżultati tal-istudji pre-kliniċi ta' hawn fuq urew li M2 (SL59.0955) induċa lmikronukleji in vitro u in vivo, prinċipalment permezz ta' mekkaniżmu anewġeniku taħt il-kundizzjonijiet kollha ta' kura.
English: In the first database, 11 cases secondary to exposure during pregnancy were reported:
Maltese: Fl-ewwel database, kienu rrappurtati 11-il każ sekondarji għal esponiment waqt it-tqala:
English: To address it, the proposed RMM (indication limited to acute conditions, treatment duration limited to seven consecutive days, avoidance of long-term use) were considered appropriate by the CHMP.
Maltese: Biex jindirizza dan, l-RMM propost (l-indikazzjoni tiġi limitata għal kundizzjonijiet akuti, it-tul tal-kura jiġi limitat għal sebat ijiem konsekuttivi, l-evitar ta' użu fit-tul) kienu meqjusa adegwati mis-CHMP.
English: Subsequent mechanistic analysis via the use of fluorescence in situ hybridization (FISH) with pan centromeric DNA probes demonstrated that micronuclei were predominantly generated via an aneugenic (numerical chromosome abnormality) mechanism under all treatment conditions; aneuploidy was clearly confirmed by centromere staining.
Maltese: Analiżi mekkanistika sussegwenti bl-użu ta' ibridizzazzjoni florexxenti in-situ (FISH) bi probes panċentromeriċi tad-DNA wriet li l-mikronukleji kienu fil-biċċa l-kbira ġenerati permezz ta' mekkaniżmu anewġeniku (abnormalità numerika fil-kromożomi) taħt il-kundizzjonijiet kollha ta' kura; l-anewplojdija kienet ikkonfermata b'mod ċar permess ta' tlewwin taċċentromeru.
English: For the purpose of the review of this risk, the MAHs provided an analysis of this genotoxic potential for each systemic route of administration, together with an analysis of possible risk factors, including relevant criteria such as dose and duration of treatment.
Maltese: Għall-fini tar-reviżjoni ta' dan ir-riskju, l-MAHs ipprovdew analiżi ta' dan il-potenzjal ġenotossiku għal kull rotta sistemika tal-għoti, flimkien ma' analiżi ta' fatturi ta' riskju possibbli, inkluż kriterji rilevanti bħad-doża u t-tul tal-kura.
English: Based on common use in acute settings, other recommendations for the posology were included as the limitation of the treatment duration to 7 days in case of oral administration and to 5 days in case of IM administration; a reference to the maximum dose allowed was also recommended .Finally a 12 hours interval between 2 consecutive administrations was requested in view of the elimination half-life of the M2 metabolite.
Maltese: Abbażi tal-użu komuni f'sitwazzjonijiet akuti, rakkomandazzjonijiet oħra għall-pożoloġija ġew inklużi li jinkludu l-limitazzjoni tat-tul tal-kura għal 7 ijiem fil-każ ta' għoti orali u sa 5 ijiem fil-każ ta' għoti ġol-muskoli; referenza għad-doża massima permessa kienet rakkomandata wkoll.
English: Under the assay conditions, the No Observed Adverse Effect Level (NOAEL) and lowest-observedadverse-effect level (LOAEL) were also considered but while acknowledging that chromosome non disjunction (CND) is the most appropriate end-point to investigate when looking for low-dose effects of spindle poisons, conclusion on the search for threshold doses for aneuploidy induction was not possible to draw.
Maltese: Taħt il-kondizzjonijiet tal-analiżi, il-livell Bla Effett Ħażin Osservat (NOAEL) u l-anqas livell ta' effett ħażin osservat (LOAEL) kienu kkunsidrati wkoll iżda filwaqt huwa rikonoxxut li n-nondisġunzjoni talkromożomi (CND) huwa l-aktar punt ta' tmiem adegwat biex jiġi investigat meta wieħed ikun qed jinvestiga l-effetti f'doża baxxa ta' veleni tal-magħżel, ma kienitx possibbli li tinġibed konklużjoni dwar ittfittxija għad-dożi ta' limitu għall-induzzjoni ta' anewplojdija.
English: The CHMP considers that the clinical evidence within the cases reported by the MAHs concerning the consequences of aneuploidy in humans does not allow drawing definitive conclusions.
Maltese: Is-CHMP iqis li l-evidenza klinika fil-każijiet irrapportati mill-MAHs dwar il-konsegwenzi ta' anewplojdija fil-bnedmin ma tippermettix li jinġibdu konklużjonijiet definittivi.
English: However it is still controversial if aneuploidy is a contributing cause or merely a consequence of neoplastic transformation.
Maltese: Madankollu għadu kontroversjali jekk l-anewplojdija hijiex kawża kontributorja jew hijiex sempliċiment konsegwenza ta' trasformazzjoni neoplastika.
English: TCC is indicated for the treatment of painful muscular contractures in different settings.
Maltese: TCC huwa indikat għall-kura ta' kontrazzjonijiet muskolari li jikkawżaw l-uġigħ f'sitwazzjonijiet differenti.
English: In the two in vitro and in vivo preclinical studies conducted, the findings (increase in the incidence of micronucleated cells) were observed at concentrations/exposures close to the exposures measured in human at therapeutic doses.
Maltese: Fiż-żewġ studji prekliniċi in vitro u in vivo li saru, is-sejbiet (żieda fl-inċidenza ta' ċelloli multinukleati) kienu osservati f'konċentrazzjonijiet/esponimenti viċin l-esponimenti mkejla fil-bnedmin f'dożi terapewtiċi.
English: The CHMP considered that a Direct healthcare professional communication (DHPC) was needed to inform on the outcome of the present review, including the updated indication, the clinical use for these products (short-term) and to highlight the genotoxic risk.
Maltese: Is-CHMP ikkunsidra li kien hemm il-ħtieġa ta' Komunikazzjoni diretta lill-professjonisti tal-kura tassaħħa (DHPC) biex tinforma dwar l-eżitu tar-reviżjoni attwali, inkluż l-indikazzjoni aġġornata, l-użu kliniku għal dawn il-prodotti (għal żmien qasir) u biex tenfasizza r-riskju ġenotossiku.
English: [400 mg MR pharmaceutical form]
Maltese: [400 mg MR għamla farmaċewtika]
English: [Solution for injection (i.m.)]
Maltese: [Soluzzjoni għall-injezzjoni (i.m.)]
English: Very common: Transaminases increased.
Maltese: Komuni ħafna: Żieda fit-transaminases.
English: Not known: Hepatitis, liver failure.
Maltese: Epatite, falliment tal-fwied.
English: Section 4.1 Therapeutic indications
Maltese: Sezzjoni 4.4
English: Liver function tests must be performed at weekly intervals during treatment with <Product Name> because increased liver enzyme levels, hepatitis and liver failure have been reported in association with flupirtine therapy.
Maltese: Testijiet tal-funzjoni tal-fwied għandhom isiru f'intervalli ta' ġimgħa waqt it-trattament b'<Isem ilProdott> peress li ġew rapportati livelli ogħla ta' enzimi tal-fwied, epatite u insuffiċjenza tal-fwied li kienu marbuta ma' terapija b'flupirtine.
English: [All pharmaceutical forms] Hepatobiliary disorders:
Maltese: [Għamliet farmaċewtiċi kollha] Disturbi fil-fwied u fil-marrara:
English: Concomitant use of flupirtine with other drugs known to cause drug induced liver injury must be avoided (see Section 4.5).
Maltese: L-użu konkomittanti ta' flupirtine u mediċini oħra magħrufa li jikkaġunaw ġrieħi fil-fwied indotti mill-mediċina għandu jiġi evitat (ara sezzjoni 4.5).
English: Patients should be advised to remain vigilant for any symptoms compatible with hepatic damage during treatment with <Product Name> (e.g. loss of appetite, nausea, vomiting, abdominal pain, fatigue, dark urine, jaundice, pruritus) and to discontinue intake of <Product Name> and to seek medical advice immediately if any such symptoms occur.
Maltese: Il-pazjenti għandhom jingħataw parir biex jibqgħu svelti għal kull sintomu marbut ma' ħsara fil-fwied waqt il-kura b'<Isem il-Prodott> (eż, nuqqas t'aptit, tqalligħ, remettar, uġigħ addominali, għeja, awrina skura, suffejra, deni) u sabiex jieqfu jieħdu <Isem il-Prodott> u sabiex ifittxu għajnuna medika minnufih jekk sintomi bħal dawn iseħħu.
English: < Product Name > must only be used if treatment with other analgesics (e.g. non-steroidal antiinflammatory drugs, weak opioids) is contraindicated.
Maltese: < Isem il-Prodott > għandu jintuża biss kemm-il darba t-trattament b'analġeżiċi oħra (eż. mediċini antinfjammatorji mhux sterojdi, opijojdi dgħajfin) huwa kontraindikat.
English: Very common: Liver enzymes increased Frequency not known: Hepatitis, liver failure
Maltese: Komuni ħafna: Enzimi tal-fwied ogħla.
English: Concomitant use of flupirtine with other drugs known to cause drug induced liver injury must be avoided (see Section 4.3).
Maltese: L-użu fl-istess waqt ta' flupirtine u mediċini oħra magħrufa li jikkaġunaw ġrieħi fil-fwied indotti mill-mediċina għandu jiġi evitat (ara sezzjoni 4.3).
English: [100 mg IR pharmaceutical form, suppositories] Flupirtine should be administered at the lowest effective dose for the shortest duration necessary to achieve adequate analgesia.
Maltese: [100 mg IR għamla farmaċewtika, suppożitorji] Flupirtine għandu jingħata fl-inqas doża effettiva għall-inqas tul ta' żmien meħtieġ sabiex tinkiseb analġesja xierqa.
English: [Oral pharmaceutical forms and suppositories] Treatment of acute pain in adults.
Maltese: Trattament għal uġigħ akut fl-adulti.
English: [All pharmaceutical forms]
Maltese: [Għamliet farmaċewtiċi kollha]
English: Use in children and adolescents
Maltese: Użu fit-tfal u fl-adolexxenti
English: A. Summary of Product Characteristics (SmPC) <This medicinal product is subject to additional monitoring.
Maltese: Sommarju tal-Karatteristiċi tal-Prodott (SKP) < Dan il-prodott mediċinali hu suġġett għal monitoraġġ addizzjonali.
English: [Oral pharmaceutical forms and suppositories] Do not <take><use><Product name> if you: suffer from pre-existing liver disease suffer from alcoholism concomitantly use other medicinal products known to cause drug induced liver injury.
Maltese: X'inhu <Isem il-Prodott> u għal xiex jintuża [Din it-taqsima għandha tissostitwixxi kull waħda eżistenti u għandha tinqara kif ġej:] [Għamliet farmaċewtiċi orali u suppożitorji]
English: See the end of section 4 for how to report side effects.
Maltese: Ara t-tmiem ta' sezzjoni 4 biex tara kif għandek tirrapporta effetti sekondarji.>
English: Annex III Amendments to relevant sections of the summary of product characteristics and package leaflet
Maltese: Sezzjoni 4.8 Effetti mhux mixtieqa [il-kliem t'hawn isfel għandu jiddaħħal f'din is-sezzjoni]
English: Rare: urticaria.
Maltese: Rari: urtikarja.
English: Human Papillomavirus = HPV
Maltese: Papillomavirus Uman = HPV.
English: 20 micrograms 40 micrograms 40 micrograms 20 micrograms.
Maltese: 20 mikrogramma 40 mikrogramma 40 mikrogramma 20 mikrogramma
English: 20 micrograms
Maltese: 20 mikrogramma
English: 40 micrograms
Maltese: 40 mikrogramma
English: Evidence of Anamnestic (Immune Memory) Response
Maltese: Evidenza ta' Reazzjoni Anamnestika (Memorja Immuni)
English: (95% CI: 67.2, 100) and 100% (95% CI: 55.4, 100), respectively,
Maltese: (95% CI: 67.2, 100) u 100% (95% CI: 55.4, 100), rispettivament,
English: IM use.
Maltese: Użu IM.
English: Few individuals (0.2%) discontinued due to adverse reactions.
Maltese: Ftit mill-individwi (0.2 %) waqqfu minħabba reazzjonijiet avversi.
English: GMT- Geometric mean titre in mMU/ml (mMU = milli-Merck units)
Maltese: GMT- Titre Ġeometriku Medju f'mMU/ml (mMU=unitajiet milli-Merck)
English: Use with hormonal contraceptives
Maltese: Użu ma' kontraċettivi ormonali
English: [Very Common (≥1/10); Common (≥1/100 to 1/10); Uncommon (≥1/1,000 to 1/100); Rare (≥1/10,000 to 1/1,000); Very Rare (1/10,000)]
Maltese: Ħafna (≥ 1/10); Komuni (≥ 1/100 sa < 1/10); Mhux Komuni (≥ 1/1,000 sa < 1/100); Rari (≥ 1/10,000 sa < 1/1,000);
English: adsorbed on amorphous aluminium hydroxyphosphate sulphate (0.225 mg Al).
Maltese: adsorbit fuq amorphous aluminium hydroxyphosphate sulphate (0.225 mg Al).
English: Date of first authorisation: 20 September 2006
Maltese: Data tal-ewwel awtorizzazzjoni: 20 ta' Settembru 2006
English: Persistence of Immune Response of Silgard
Maltese: Persistenza ta' Rispons Immuni ta' Silgard
English: Merck Sharp & Dohme Ireland (Human Health)
Maltese: Merck Sharp & Dohme Ireland (Human
English: n % of seropositive subjects
Maltese: % ta' individwi seropożittivi
English: Silgard will not protect against every type of Human Papillomavirus.
Maltese: Silgard mhux ser jipproteġi kontra kull tip ta' Papillomavirus Uman.
English: Sodium chloride, L-histidine, polysorbate 80, sodium borate, water for injections.
Maltese: Sodium chloride, L-histidine, polysorbate 80, sodium borate, ilma għall-injezzjonijiet.
English: The median duration of follow-up for the combined protocols (005, 007, 013, and 015) was 3.6 years.
Maltese: It-tul medjan tal-follow-up għall-protokolli flimkien (005, 007, 013, and 015) kien 3.6 snin.
English: HPV 11 885 HPV 16 882 HPV 18 887
Maltese: HPV 6 HPV 11 HPV 16 HPV 18
English: During the clinical development program, 3,819 women (vaccine = 1,894 vs. placebo = 1,925) reported at least one pregnancy.
Maltese: Matul il-programm ta' żvilupp kliniku, 3,819-il mara (vaċċin = 1,894 vs. plaċebo = 1,925) irrappurtaw mill-inqas tqala waħda matul il-perijodu ta' vaċċinazzjoni.
English: % Efficacy
Maltese: % Effikaċja
English: Impact on Definitive Cervical Therapy Procedures
Maltese: Impatt fuq Proċeduri ta' Terapija Ċervikali Definittivi
English: In clinical studies, 57.5% of women aged 16 to 26 years and 31.2% of women aged 24 to 45 years who received Silgard used hormonal contraceptives during the vaccination period.
Maltese: Fi studji kliniċi, 57.5 % tan-nisa ta' età bejn 16 u 26 sena u 31.2% tan-nisa ta' età bejn 24 sena u 45 sena li rċivew Silgard użaw kontraċettivi ormonali matul il-perijodu ta' vaċċinazzjoni.
English: Vaccination is not a substitute for routine cervical screening.
Maltese: It-tilqima ma tieħux post screening ċervikali ta' rutina.
English: No data
Maltese: Dejta
English: Efficacy was based on reductions in HPV 31-related CIN 2/3 or AIS Efficacy was based on reductions in HPV 31-, 33-, 52-, and 58-related CIN 2/3 or AIS Includes assay-identified non-vaccine HPV types 31, 33, 35, 39, 45, 51, 52, 56, 58, and 59.
Maltese: L-effikaċja kienet ibbażata fuq tnaqqis f'CIN 2/3 jew AIS relatati ma' HPV 31-, 33-, 52-, u 58 Tinkludi tipi ta' HPV mhux vaċċin identifikati mill-assaġġ 31, 33, 35, 39, 45, 51, 52, 56, 58, u
English: The term "premalignant genital lesions" in section 4.1 corresponds to high-grade cervical intraepithelial neoplasia (CIN 2/3), high-grade vulvar intraepithelial neoplasia (VIN 2/3) and highgrade vaginal intraepithelial neoplasia (VaIN 2/3).
Maltese: It-terminu "leżjonijiet ġenitali premalinni" f'sezzjoni 4.1 jikkorrispondi għal neoplasja intraepiteljali ċervikali ta' grad għoli (CIN 2/3), neoplasja intraepiteljali vulvari ta' grad għoli (VIN 2/3) u neoplasja intraepiteljali vaġinali ta' grad għoli (VaIN 2/3).
English: HPV types 6 and 11 are responsible for approximately 90% of
Maltese: HPV tipi 6 u 11 huma responsabbli għal madwar 90 % tal-każijiet ta' felul
English: Number of cases Number of individuals*
Maltese: każijiet Numru ta' individwi*
English: Data from stability studies demonstrate that the vaccine components are stable for 72 hours when stored at temperatures from 8°C to 42°C.
Maltese: Dejta minn studji dwar stabbilità turi li l-komponenti tal-vaċċin huma stabbli għal 72 siegħa meta jinħażen f'temperaturi minn 8°C sa 42°C.
English: Silgard, suspension for injection:
Maltese: Silgard, suspensjoni għall-injezzjoni:
English: Efficacy was evaluated against HPV 6-, 11-, 16-, 18-related external genital warts, penile/perineal/perianal intraepithelial neoplasia (PIN) grades 1/2/3, and persistent infection.
Maltese: L-effikaċja kienet evalwata għal kontra fellul ġenitali estern marbut mal-HPV 6, 11, 16, 18, neoplasja tal-intraepitilju tal-pene/perineali/perianali (PIN) ta' gradi 1/2/3, u infezzjoni persistenti.
English: % Efficacy (95%CI)
Maltese: % Effikaċja (95%CI)
English: In only 1 of 11 specimens HPV 16 was found (at Month 32.5) and was not detected in tissue excised during LEEP (Loop Electro-Excision Procedure).
Maltese: Jekk instab kampjun 1 biss mill-11-il kampjuni HPV 16 (f'Xahar 32.5) u dan ma ġiex relevant fit-tessut maqtugħ matul LEEP (Loop Electro-Excision Procedure).
English: HPV 6 and 11 are responsible for approximately 90% of genital warts and 10% of low grade cervical intraepithelial neoplasia (CIN 1).
Maltese: HPV 6 u 11 huma responsabbli għal madwar ta' 90 % tal-każijiet ta' felul ġenitali u 10% għal neoplasja intraepiteljali ċervikali ta' livell baxx (CIN 1).