qanastek/EMEA-V3 huggingface dataset:
20 µg/ 20 µg Human Papilloma Virus - 16/ Human Papilloma Virus -18 L 1 proteins
Suspensjoni għall - injezzjoni
1/ 1
1 20 µg / 20 µg Papilloma Virus Uman - 16 / Papilloma Virus Uman - 18 proteini L1
Cervarix suspension for injection Human Papillomavirus vaccine [Types 16, 18] (Recombinant, adjuvanted, adsorbed)
Cervarix, suspensjoni għall- injezzjoni Vaċċin tal- Papillomavirus Uman [Tipi 16, 18] (Rikombinanti, imsaħħaħ, adsorbit)
1 dose (0.5 ml) contains:
Doża waħda (0. 5 ml) ikun fiha:
Human Papillomavirus1 type 16 L1 protein2,3,4 Human Papillomavirus1 type 18 L1 protein2,3,4 1 Human Papillomavirus = HPV 2 adjuvanted by AS04 containing:
Papillomavirus Uman1 tat- tip 16 LI2, 3, 4 Papillomavirus Uman1 tat- tip 18 LI2, 3, 4 1 Papillomavirus Uman = HPV 2 imsaħħaħ b’ AS04 li fih:
3-O-desacyl-4’ - monophosphoryl lipid A (MPL)3 3
3- O- desacyl- 4 ’ - monophosphoryl lipid A (MPL) 3 3 adsorbit fuq aluminium hydroxide, idratat, (Al( OH) 3) 4
50 micrograms
50 mikrogrammi total ta ’ 0. 5 milligrammi Al3+
0.5 milligrams Al3+ in total
Proteina 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 Rix4446 derivati minn Trichoplusia ni.
For a full list of excipients, see section 6.1.
Għall- lista kompleta ta ’ sustanzi mhux attivi, ara s- sezzjoni 6. 1.
Turbid white suspension.
Suspensjoni bajda mdardra.
Upon storage, a fine white deposit with a clear colourless supernatant may be observed.
Meta tinħażen jitfaċċa depożitu żgħir abjad b’ sustanza ċara bla kulur fil - wiċċ.
Cervarix is a vaccine for the prevention of premalignant cervical lesions and cervical cancer causally related to Human Papillomavirus (HPV) types 16 and 18 (see section 5.1).
Cervarix huwa vaċċin għall- prevenzjoni ta ’ leżjonijiet fl- għonq ta ’ l- utru fi stadju ta ’ qabel il- kanċer u għall- kanċer fl- għonq ta ’ l- utru li l- kawża tiegħu hija relatata mal- Papillomavirus Uman (HPV) tat- tipi 16 u 18 (ara sezzjoni 5. 1).
The indication is based on the demonstration of efficacy in women aged 15-25 years following vaccination with Cervarix and on the immunogenicity of the vaccine in girls and women aged 10-25 years.
L- indikazzjoni hi bbażata fuq il- wiri ta ’ effikaċja ta ’ Cervarix f’ nisa ta ’ bejn il- 15 u l- 25 sena wara li jkunu mlaqqmin b’ Cervarix u fuq l- immunoġeniċita` tal- vaċċin fi tfajliet u nisa ta ’ bejn l- 10 snin u l - 25 sena.
See section 5.1 for information on the evidence that supports the efficacy of Cervarix in prevention of premalignant cervical lesions associated with HPV-16 and/ or HPV-18.
Ara sezzjoni 5. 1 għal informazzjoni fuq l- evidenza li ssostni l- effikaċja ta ’ Cervarix fil- prevenzjoni ta ’ leżjonijiet fl- għonq ta ’ l- utru fi stadju ta ’ qabel il- kanċer assoċjati ma ’ HPV- 16 u/ jew HPV- 18.
The use of Cervarix should be in accordance with official recommendations.
Cervarix għandu jintuża skond ir- rakkomandazzjonijiet uffiċjali disponibbli.
The recommended vaccination schedule is 0, 1, 6 months.
L- iskeda ta ’ vaċċinazzjoni rrakkomandata hi ta ’ 0, 1, 6 xhur.
The need for a booster dose has not been established (see section 5.1).
Il- ħtieġa ta ’ doża booster ma ġietx stabbilita (ara s- sezzjoni 5. 1)
2 It is recommended that subjects who receive a first dose of Cervarix complete the 3-dose vaccination course with Cervarix (see section 4.4).
2 Hu rrakkomandat li suġġetti li jirċievu l- ewwel doża ta ’ Cervarix jispiċċaw il- kors ta ’ tilqim fi 3 dożi b' Cervarix (ara sezzjoni 4. 4).
Girls aged less than 10 years:
Bniet ta ’ anqas minn 10 snin:
Cervarix is not recommended for use in girls below 10 years of age due to lack of data on safety and immunogenicity in this age-group.
Cervarix m’ huwiex rakkomandat għall- użu fi bniet taħt l- 10 snin minħabba n- nuqqas ta ’ informazzjoni fuq is- sigurtà u l- immunoġeniċità f’ din l- età.
Cervarix is for intramuscular injection in the deltoid region (see also sections 4.4 and 4.5).
Cervarix qiegħed għal injezzjoni fil- muskoli fir- reġjun tad- deltojde (ara wkoll is- sezzjonijiet 4. 4 u 4. 5).
Hypersensitivity to the active substances or to any of the excipients.
Sensittivita` eċċessiva għal xi sustanzi attivi jew għal xi waħda mis- sustanzi mhux attivi.
Administration of Cervarix should be postponed in subjects suffering from an acute severe febrile illness.
L- għoti ta ’ Cervarix għandu jiġi pospost f’ persuni li jkunu qed ibatu minn xi mard akut b’ deni qawwi.
However, the presence of a minor infection, such as a cold, is not a contraindication for immunisation.
Madankollu, meta jkun hemm xi infezzjoni żgħira, bħal xi riħ, dan m’ għandux ikun ta ’ kontra - indikazzjoni għall- immunizzazzjoni.
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.
Bħal fil- każ ta ’ kull vaċċin għall- injezzjoni, kura medika u sorveljanza kif suppost għandhom dejjem ikunu disponibbli fil- każ ta ’ xi effett anafilattiku rari wara li jingħata l- vaċċin.
Cervarix should under no circumstances be administered intravascularly or intradermally.
Cervarix m’ għandu qatt jingħata fil- vini jew fil- ġilda.
No data are available on subcutaneous administration of Cervarix.
Ma jeżistix tagħrif dwar l- għoti ta ’ Cervarix taħt il- ġilda.
As with other vaccines administered intramuscularly, Cervarix should be given with caution to individuals with thrombocytopenia or any coagulation disorder since bleeding may occur following an intramuscular administration to these subjects.
Bħall- vaċċini l- oħra kollha li jingħataw ġol- muskoli, Cervarix għandu jingħata b’ attenzjoni lil individwi bi tromboċitopenija jew b’ xi problema ta ’ koagulazzjoni għax jista ’ jkun hemm ħruġ ta ’ demm wara li jingħata ġol- muskoli f’ suġġetti bħal dawn.
Vaccination is not a substitute for regular cervical screening or for precautions against exposure to HPV and sexually transmitted diseases.
It- tilqim m’ huwiex sostitut għal screening ċervikali regolari jew għal prekawzjonijiet li għandhom jittieħdu għal HPV jew mard ieħor li jingħata sesswalment.
As with any vaccine, a protective immune response may not be elicited in all vaccinees.
Bħal fil- każ ta ’ kull vaċċin, rispons ta ’ immunita` protettiva jista ’ ma jirriżultax f’ kull min jingħata l- vaċċin.
Cervarix protects against disease caused by HPV types 16 and 18.
Cervarix jipproteġi kontra l- mard ikkawżat minn HPV ta ’ tipi 16 u 18.
Other oncogenic HPV types can also cause cervical cancer and therefore routine cervical screening remains critically important and should follow local recommendations.
Tipi ta ’ HPV onkoġeniċi oħra jistgħu jikkawżaw ukoll kanċer fl- għonq ta ’ l- utru u għalhekk cervical screening ta ’ rutina jibqa ’ importanti b’ mod kritiku u għandu jsegwi ir - rakkomandazzjonijiet lokali.
Cervarix has not been shown to have a therapeutic effect.
Cervarix ma ntweriex li għandu effett terapewtiku.
The vaccine is therefore not indicated for treatment of cervical cancer, cervical intraepithelial neoplasia (CIN) or any other established HPV- related lesions.
Għalhekk il- vaċċin m' huwiex indikat għall - kura tal- kanċer tal- għonq ta 'l- utru, neoplażja ġewwa ċ- ċellula tal- epitelju tal- għonq tal- utru (CIN) jew xi leżjoni stabbilita relatata ma ’ HPV.
Cervarix does not prevent HPV-related lesions in women who are infected with HPV-16 or HPV-18 at the time of vaccination.
Cervarix ma jipprevenix leżjonijiet relatati ma 'HPV f' nisa infettati b' HPV- 16 jew HPV- 18 fiż- żmien tal- vaċċinazzjoni.
Duration of protection has not fully been established.
It- tul tal- prevenzjoni ma ġiex stabbilit.
Timing and need of booster dose(s) has not been investigated.
Għadu ma ġiex investigat iż- żmien adatt u l- bżonn ta ’ doża( i) booster.
There are no data on the use of Cervarix in subjects with impaired immune responsiveness such as HIV infected patients or patients receiving immunosuppressive treatment.
Ma jeżistix tagħrif dwar l- użu ta ’ Cervarix f’ suġġetti b’ indeboliment tar- rispons immunitarju bħal fil- każ ta ’ pazjenti infettati bl- HIV jew pazjenti fuq kura immunosoppressiva.
As with other vaccines, an adequate immune response may not be elicited in these individuals.
Bħal b’ vaċċini oħra, jista ’ ma jkunx hemm rispons immunitarju tajjeb biżżejjed f’ dawn l- individwi.
There are no safety, immunogenicity or efficacy data to support interchangeability of Cervarix with other HPV vaccines.
Ma hemmx informazzjoni fuq is- sigurtà, l- immunoġeniċità jew l- effikaċja biex issostni is - sostituzzjoni ta ’ Cervarix b’ vaċċini oħra ta 'HPV.
4.5 Interaction with other medicinal products and other forms of interaction
3 4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarjiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
In all clinical trials individuals who had received immunoglobulin or blood products within 3 months prior to the first vaccine dose were excluded.
Fl- istudji kliniċi kollha kienu esklużi individwi li kienu ingħataw immunoglobulins jew prodotti tad - demm fit- 3 xhur ta ’ qabel l- ewwel vaċċin.
3 Use with other vaccines
Użu ma ’ vaċċini oħra
Data have not been generated on the concomitant administration of Cervarix and other vaccines.
Ma ħariġx tagħrif dwar l- għoti konkomitanti ta ’ Cervarix u vaċċini oħra.
Use with hormonal contraceptive
Użu ma ’ kontraċettiv ormonali
In clinical efficacy studies, approximately 60% of women who received Cervarix used hormonal contraceptives.
Fi studji dwar effikaċja klinika, madwar 60% ta ’ nisa li jkunu ħadu Cervarix użaw kontraċettivi ta ’ l - ormoni.
There is no evidence that the use of hormonal contraceptives has an impact on the efficacy of Cervarix.
M’ hemmx evidenza li l- użu ta ’ kontraċettivi ta ’ l- ormoni għandu xi impatt fuq l- effikaċja ta ’ Cervarix.
Use with systemic immunosuppressive medicinal products
Użu ma ’ ma mediċini immunosoppressivi sistemiċi
As with other vaccines it may be expected that, in patients receiving immunosuppressive treatment, an adequate response may not be elicited.
Bħal fil- każ ta ’ vaċċini oħra hu mistenni illi, f’ pazjenti fuq kura immunosoppressiva, jista ’ ma jirriżultax rispons adegwat.
Specific studies of the vaccine in pregnant women were not conducted.
Għadhom ma sarux studji speċifiċi fuq nisa fit- tqala.
During the pre-licensure clinical development program, a total of 1,737 pregnancies were reported including 870 in women who had received Cervarix.
Matul il- programm ta ’ żvilupp kliniku ta ’ qabel il- liċenzjar, kienu irrapurtati total ta '1, 737 tqala fosthom 870 f' nisa li kienu ingħataw Cervarix.
Overall, the proportions of pregnant subjects who experienced specific outcomes (e. g., normal infant, abnormal infants including congenital anomalies, premature birth, and spontaneous abortion) were similar between treatment groups.
Kollox ma kollox, il- popolazzjoni ta 'suġġetti tqal li esperjenzaw riżultati speċifiċi (eż., trabi normali, trabi mhux normali li jinkludu anomaliji konġenitali, twelid qabel iż- żmien u abort spontanju) kienu simili bejn iż- żewġ gruppi ta ’ kura.
Animal studies do not indicate direct or indirect harmful effects with respect to fertility, pregnancy, embryonal/ foetal development, parturition or post-natal development (see section 5.3).
Studji fl- annimali ma jindikawx xi effetti ħżiena diretti jew indiretti f’ dawk li huma fertilita`, tqala, żvilupp ta ’ l- embriju/ fetu, proċess tat- twelid jew żvilupp wara t- twelid (ara sezzjoni 5. 3).
These data are insufficient to recommend use of Cervarix during pregnancy.
Din l- informazzjoni m’ hijiex biżżejjed biex tirrakkomanda l- użu ta ’ Cervarix waqt it- tqala.
Vaccination should, therefore, be postponed until after completion of pregnancy.
Il- vaċċinazzjoni għandha, għalhekk, tiġi posposta sa wara t- tqala.
The effect on breast-fed infants of the administration of Cervarix to their mothers has not been evaluated in clinical studies.
Għadu ma ġiex evalwat fi studji kliniċi l- effett fuq trabi li jerdgħu meta l- ommjiet jingħataw Cervarix.
Cervarix should only be used during breast-feeding when the possible advantages outweigh the possible risks.
Waqt li mara tkun qed tredda ’ Cervarix għandu jintuża biss meta l- vantaġġi mistennija jkunu akbar mir- riskji involuti.
4.7 Effects on the ability to drive and use machines
4. 7 Effetti fuq il- ħila biex issuq u tħaddem magni
No studies on the effects on the ability to drive or use machines have been performed.
Ma sarux studji dwar l- effetti fuq il- ħila biex issuq jew tħaddem magni.
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 subjects whilst 13,811 subjects received control.
Fi studji kliniċi, li irreġistraw bniet u nisa minn 10 snin sa 72 sena (li minnhom 79. 2% kellhom bejn l - 10 u l- 25 fiż- żmien tar- reġistrazzjoni), Cervarix ingħata lil 16, 142 il- suġġett filwaqt li 13, 811 ingħataw kontroll.
These subjects were followed for serious adverse events over the entire study period.
Dawn is- suġġetti ġew segwiti għal eventi avversi serji matul il- perjodu kollu ta ’ studju.
In a pre-defined subset of subjects (Cervarix = 8,130 versus control = 5,786), adverse events were followed for 30 days after each injection.
F- sub- grupp sekondarju ta ’ suġġetti definit minn qabel (Cervarix = 8, 130 kontra kontroll = 5, 786) eventi avversi ġew segwiti għal 30 ġurnata wara kull tilqima.
The most common adverse reaction observed after vaccine administration was injection site pain which occurred after 78% of all doses.
L- aktar reazzjoni avversa komuni osservata wara li ngħata l- vaċċin kienet ta ’ uġigħ fis- sit fejn tingħata l- injezzjoni li seħħ wara 78% tad- dożi kollha.
The majority of these reactions were of mild to moderate severity and were not long lasting.
Il- biċċa l- kbira ta ’ dawn ir- rerazzjonijiet kienu ta ’ qawwa ħafifa sa moderata u mhux fit- tul.
Adverse reactions considered as being at least possibly related to vaccination have been categorised by frequency.
4 Reazzjonijiet avversi kkunsidrati li huma possibilment relatati mal- vaċċinazzjoni ġew kategorizzati skond il- frekwenza.
Very common (≥ 1/ 10)
Il- frekwenzi huma rappurtati bħala:
4 Common (≥ 1/ 100 to < 1/ 10) Uncommon (≥ 1/ 1,000 to < 1/ 100)
Komuni ħafna (≥1/ 10) Komuni (≥1/ 100 to < 1/ 10) Mhux komuni (≥1/ 1, 000 to < 1/ 100)
Very common: headache Uncommon: dizziness
Komuni ħafna: uġigħ ta ’ ras Mhux komuni: sturdamenti
Common: gastrointestinal symptoms including nausea, vomiting, diarrhoea and abdominal pain
Komuni: sintomi gastro- intestinali inklużi dardir, remettar, dijareja u wġigħ addominali
Common: itching/ pruritus, rash, urticaria
Komuni: ħakk/ prurite, raxx, urtikarja
Very common: myalgia Common: arthralgia
Disturbi muskulo- skeltrali u tal- connective tissue; Komuni ħafna: majalġja Komuni: artralġja
Infections and infestations:
Infezzjonijiet u infestazzjonijiet:
Uncommon: upper respiratory tract infection
Mhux komuni: infezzjoni fl- apparat respiratorju ta ’ fuq
Very common: injection site reactions including pain, redness, swelling; fatigue Common: fever (≥ 38°C) Uncommon: other injection site reactions such as induration, local paraesthesia
Disturbi ġenerali u kondizzjonijiet ta ’ mnejn jingħata Komuni ħafna: reazzjonijiet fis- sit tal- vaċċinazzjoni inklużi uġigħ, ħmura u nefħa; għeja Komuni: deni (≥38°Ċ) Mhux komuni: reazzjonijiet oħra fis- sit tal- vaċċinazzjoni bħal għebusija, paraestesija lokali
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.
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.
No case of overdose has been reported.
Ma ġie rappurtat l- ebda każ ta ’ doża eċċessiva.
Papillomavirus vaccines, ATC code:
Vaċċini għal Papillomavirus, kodiċi ATC:
Mechanism of action
Mekkaniżmu ta ’ azzjoni
Cervarix is a non-infectious recombinant vaccine prepared from the highly purified virus-like particles (VLPs) of the major capsid L1 protein of oncogenic HPV types 16 and 18.
Cervarix hu vaċċin rekombinant mhux infettiv magħmul mill- partiċelli qishom virus (VLPs) ippurifikati ħafna tal- proteina maġġuri capsid L1 tat- tipi onkoġeniċi HPV 16 u 18.
Since the VLPs contain no viral DNA, they cannot infect cells, reproduce or cause disease.
Billi l- VLPs ma fihom ebda DNA virali, ma jistgħux jinfettaw ċelluli, jirriproduċu jew jikkaġunaw mard.
Animal studies have shown that the efficacy of L1 VLP vaccines is largely mediated by the development of a humoral immune response.
Studji fuq annimali wrew li l- effikaċja tal- vaċċini VLP L1 hi fil- parti l- kbira megħjuna bl- iżvilupp ta ’ rispons immunitarju bil- produzzjoni tal- antikorpi.
HPV-16 and HPV-18 are responsible for approximately 70% of cervical cancers across all regions worldwide.
HPV- 16 u HPV- 18 huma responsabbli għal bejn wieħed u ieħor 70% ta ’ kanċer fl- għonq ta ’ l- utru fir - reġjuni kollha tad- dinja.
Clinical studies
5 Studji kliniċi
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.
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.
The phase II trial (study 001/ 007) enrolled only women who:
Fl- istudju f’ Fażi II (studju 001/ 007) kienu irreġistrati biss nisa li:
- Were tested negative for oncogenic HPV DNA of types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56,
- Kellhom riżultat negattiv għat- test għal HPV DNA onkoġeniku ta ’ tipi 16, 18, 31, 33, 35, 39,
58, 59, 66 and 68
45, 51, 52, 56, 58, 59, 66 u 68
- Were seronegative for HPV-16 and HPV-18 and
- Kienu seronegattivi għal HPV- 16 u HPV- 18 u
- Had normal cytology
- Kellhom ċitoloġija normali.
The primary efficacy endpoint was incident infection with HPV-16 and/ or HPV-18.
L- endpoint ta ’ effikaċja primarja kien il- frekwenza ta ’ infezzjoni b’ HPV- 16 u/ jew HPV- 18.
Twelve-month persistent infection was evaluated as additional efficacy endpoint.
Infezzjoni persistenti wara tnax il- xahar kienet evalwata bħala endpoint ta ’ effikaċja ieħor.
The phase III trial (study 008) enrolled women without pre-screening for the presence of HPV infection, i. e. regardless of baseline cytology and HPV serological and DNA status.
Fl -- istudju f’ Fażi III (studju 008) ġew irreġistrati nisa mingħajr pre- screening għal preżenza ta ’ infezzjoni b’ HPV i. e bla ma kienu meqjusa ċ- ċitoloġija ta ’ linja bażi u s- seroloġija ta ’ HPV u l- istatus ta ’ DNA.
The primary efficacy endpoint was CIN2+ associated with HPV-16 and/ or HPV-18.
L- endpoint ta ’ effikaċja primarja kien CIN2+ assoċjat ma ’ HPV- 16 u/ jew HPV- 18.
The secondary endpoints included 12-month persistent infection.
L- endpoints sekondarji kienu fost l- oħrajn infezzjoni persistenti wara 12 il- xahar.
Cervical Intraepithelial Neoplasia (CIN) grade 2 and 3 was used in the clinical trials as a surrogate marker for cervical cancer.
Neoplażja ġewwa ċ- ċelloli tal- epitelju ċervikali (Cervical Intraepithelial Neoplasia - CIN) grad 2 u 3 intużaw fi studji kliniċi bħala marker ieħor ta ’ kanċer ta ’ l- għonq ta ’ l- utru.
The term “ premalignant cervical lesions” in section 4.1 corresponds to high-grade Cervical Intraepithelial Neoplasia (CIN 2/ 3).
Il- frasi “ leżjonijiet fl- għonq ta ’ l- utru fi stadju ta ’ qabel il- kanċer ” f’ sezzjoni 4. 1 tikkorrispondi ma ’ Neoplażja ġewwa ċ- ċelloli tal- epitelju ċervikali (Cervical Intraepithelial Neoplasia (CIN 2/ 3)) ta ’ stadju għoli.
Prophylactic efficacy against HPV-16/ 18 infection in a population naïve to oncogenic HPV types
Effikaċja profilattika kontra infezzjoni b’ HPV- 16/ 18 f’ popolazzjoni mingħajr esperjenza ta ’ tipi HPV onkoġeniċi.
Women (N=1,113) were vaccinated in study 001 and evaluated for efficacy up to month 27.
Nisa (N=1, 113) kienu vaċċinati fi studju 001 u evalwati għall– effikaċja sa xahar 27.
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).
Grupp sekondarju ta ’ nisa (N=776) vaċċinati fi studju 001 ġie segwit fi studu 007 sa 6. 4 snin (approssimattivament 77 xahar) wara l- ewwel doża (medja ta ’ follow- up ta ’ 5. 9 snin).
There were five cases of 12-month persistent HPV-16/ 18 infection (4 HPV-16; 1 HPV-18) in the control group and one HPV-16 case in the vaccine group in study 001.
Kien hemm 5 każi ta ’ infezzjoni b’ HPV- 16/ 18 wara 12 il- xahar (4 HPV- 16, 1 HPV- 18) fil- grupp ta ’ kontroll u każ 1 ta 'HPV- 16 fil- grupp tal- vaċċin fi studju 001.
In study 007 the efficacy of Cervarix against 12-month persistent HPV-16/ 18 infection was 100% (95% CI:
Fi studju 007 l- effikaċja ta 'Cervarix kontra infezzjoni persistenti ta ’ 12 il- xahar b' HPV- 16/ 18 kienet ta ’ 100% (95% CI:
80.5; 100).
80. 5; 100).
There were sixteen cases of persistent HPV-16 infection, and five cases of persistent HPV-18 infection, all in the control group.
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.
Prophylactic efficacy in women naïve to HPV-16 and/ or HPV-18
Effikaċja profilattika f’ nisa mingħajr esperjenza ta ’ HPV- 16 u/ jew HPV- 18
In study 008 the primary analyses of efficacy were conducted in the total vaccinated cohort (TVC-1).
Fi studju 008 l- analiżi primarji ta ’ effikaċja saru fil- cohort kollu ta ’ dawk vaċċinati (TVC- 1).
This cohort included only women who were HPV DNA negative and seronegative to the relevant HPV type (HPV-16 or HPV-18) at study entry and had received at least one dose of Cervarix or the control.
Dan il - cohort inkluda biss nisa li kienu negattivi għal HPV DNA u seronegattivi għat- tipi rilevanti ta ’ HPV (HPV- 16 jew HPV- 18) meta ddaħħlu fl- istudju u li kienu irċevew mill- inqas doża waħda ta ’ Cervarix jew il- kontroll.
Women with high-grade or missing cytology (0.5%) were excluded from the efficacy analysis.
Nisa b’ ċitoloġija ta ’ grad għoli jew li ma kienetx hemm (0. 5%) kienu esklużi minn din l- analiżi ta ’ effikaċja.
Overall, 74.0% of women enrolled were naïve to both HPV-16 and HPV-18 at study entry.
Kollox ma ’ kollox, 74. 0% tan- nisa rreġistrati ma kellhomx esperjenza kemm għal HPV- 16 kif ukoll għal HPV- 18 meta ddaħħlu fl- istudju.
The efficacy of Cervarix in the prevention of CIN2+ associated with HPV-16 and/ or HPV-18 as assessed up to 15 months after the last dose of vaccine or control and the rates of 12-month persistent infection in the TVC-1 cohort are presented in the table below:
L- effikaċja ta ’ Cervarix fil- prevenzjoni ta ’ CIN2+ assoċjat ma ’ HPV- 16 u/ jew HPV- 18 kif assessjat sa 15 il- xahar wara l- aħħar doża tal- vaċċin jew kontroll u r- rati ta ’ infezzjoni persistenti wara 12 il- xahar fil- cohort TVC- 1 huma ppreżentati fit- tabella hawn taħt:
Study 008
6 Studju 008
Efficacy
Effikaċja
(97.9% CI) CIN2+ (primary endpoint)
(97. 9% CI) CIN2+ (endpoint primarju)
HPV-16 and/ or 18* HPV-16
HPV- 16 and/ or 18 * HPV- 16
90.4 (53.4; 99.3) 93.3 (47.0; 99.9)
90. 4 (53. 4; 99. 3) 93. 3 (47. 0; 99. 9)
83.3 (< 0.0; 99.9)
83. 3 (< 0. 0; 99. 9)
12-month persistent infection (secondary endpoint) HPV-16 and/ or 18* HPV-16 HPV-18
Infezzjoni persistenti wara 12 il- xahar (endpoint sekondarju) HPV- 16 and/ or 18 * HPV- 16 HPV- 18
75.9 (47.7; 90.2) 79.9 (48.3; 93.8) 66.2 (< 0.0; 94.0)
75. 9 (47. 7; 90. 2) 79. 9 (48. 3; 93. 8) 66. 2 (< 0. 0; 94. 0)
N = number of subjects included in each group of TVC-1 cohort n = number of cases *protocol-specified endpoints
N = numru ta ’ suġġetti inklużi f’ kull grupp ta ’ cohort TVC- 1 n= numru ta ’ każijiet * endpoints speċifikati mill- protokol
All endpoints reached statistical significance for HPV-16.
L- endpoints kollha laħqu importanza statistika għal HPV- 16.
However, in a pre-specified analysis (TVC-2) that was identical to the
Għal HPV- 18, id- differenza bejn il - grupp tal- vaċċin u l- kontroll ma kienetx statistikament importanti għal CIN2+ u infezzjoni persistenti wara 12 il- xahar (cohort TVC- 1).
6 TVC-1 analysis except that it excluded women with abnormal cytology at study entry, the 12 month persistent infection endpoint for HPV-18 reached statistical significance with vaccine efficacy of 89.9% (97.9% CI:
Madankollu, f’ analiżi speċifikata minn qabel (TVC- 2), li kienet l - istess bħall- analiżi TVC- 1 barra l- fatt li eskludiet nisa b’ ċitoloġija mhux normali fid- dħul ta ’ l- istudju, l- endpoint għal infezzjoni persistenti wara 12 il- xahar għal HPV- 18 laħqet importanza statistika b’ effikaċja tal- vaċċin ta ’ 89. 9% (97. 9% CI:
11.3; 99.9).
11. 3; 99. 9).
One case was observed in the vaccine group versus 10 cases in the control group.
Kien osservat każ fil- grupp tal- vaċċin versus 10 każijiet fil- grupp ta 'kontroll.
Several of the CIN2+ lesions contained multiple oncogenic types (including non-vaccine HPV types).
Ħafna mill- leżjonijiet CIN2+ kellhom ħafna tipi onkoġeniċi (li jinkludu tipi ta ’ HPV li m’ humiex preżenti fil- vaċċin).
An additional analysis was conducted to determine vaccine efficacy against lesions likely to be causally associated with HPV-16 and/ or HPV-18.
Saret analiżi oħra biex tiddetermina l- effikaċja tal- vaċċin kontra leżjonijiet li setgħu kienu assoċċjati l- aktar ma ’ HPV- 16 u/ jew HPV- 18.
This post-hoc analysis (clinical case assignment) assigned causal association of an HPV type with the lesion based on the presence of the HPV type in cytology samples prior to detection of the lesion.
Din l- analiżi post- hoc (kariga ta ’ każ kliniku) assenjat assoċjazzjoni ta ’ tip ta ’ HPV mal- leżjoni ibbażata fuq il- preżenza tat- tip ta ’ HPV f’ kampjuni ċitoloġiċi qabel instabet il- leżjoni.
Based on this case assignment, the analysis excluded 3 CIN2+ cases (2 in the vaccine group and 1 in the control group) which were not considered to be causally associated with HPV-16 or HPV-18 infections acquired during the trial.
Fuq dan il- karigu tal- każ, l- analiżi eskludiet 3 każijiet CIN2+ (2 fil- grupp tal- vaċċin u 1 fil- grupp ta ’ kontroll) li ma kienux ikkunsidrati li għandhom x’ jaqsmu ma ’ infezzjonijiet b’ HPV- 16 jew HPV- 18 li ttieħdu waqt l- istudju.
Based on this analysis there were no cases in the vaccine group and 20 cases in the control group (Efficacy 100%; 97.9% CI:
Fuq bażi ta ’ din l- analiżi ma kien hemm l- ebda każijiet fil- grupp tal- vaċċin u 20 każ fil- grupp ta kontroll (Effikaċja 100%; 97. 9% CI: 74. 2:
74.2; 100).
100).
Prophylactic efficacy in women with current or prior infection
Effikaċja profilattika f’ nisa b’ infezzjoni kurrenti jew fil- passat.
There was no evidence of protection from disease caused by the HPV types for which subjects were HPV DNA positive at study entry.
Ma kien hemm l- ebda evidenza ta 'protezzjoni minn mard minn tipi ta' HPV li għalihom is- suġġetti kellhom HPV DNA posittiv fid- dħul ta ’ l- istudju.
However, individuals already infected with one of the vaccine- related HPV types prior to vaccination were protected from clinical disease caused by the remaining HPV type.
Madankollu, individwi li digà kienu infettati b’ wieħed mit- tipi ta ’ HPV relatati mal- vaċċin qabel il- vaċċinazzjoni kienu prottetti mill- mard kliniku ikkawżat mit- tip ta ’ HPV li baqa ’.
In study 008, approximately 26% of women had evidence of current and/ or prior infection.
Fi studju 008, bejn wieħed u ieħor 26% tan- nisa kellhom evidenza ta ’ infezzjoni kurrenti u/ jew fil - passat.
HPV-16 and/ or HPV-18 seropositive).
Għoxrin fil- mija tan- nisa kellhom evidenza ta 'infezzjoni fil- passat (i. e. seropożittivi għal HPV- 16 u/ jew HPV- 18).
HPV-16 and/ or HPV-18 DNA positive) of which only 0.5% were DNA positive for both types.
Sebgħa fil- mija tan- nisa kienu infettati fiż- żmien tal- vaċċinazzjoni (i. e. posittivi għal DNA ta ’ HPV- 16 u/ jew HPV- 18) li minnhom 0. 5% biss kienu posittivi għal DNA taż - żewġ tipi.
Immunogenicity
Immunoġeniċita`
No minimal antibody level associated with protection against CIN of grade 2 or 3 or against persistent infection associated with vaccine HPV types has been identified for HPV vaccines.
L- ebda livell minimu ta ’ anti- korpi assoċjat mal- protezzjoni kontra CIN ta ’ grad 2 jew 3 jew kontra infezzjoni persistenti assoċjata ma 'tipi ta' HPV tal- vaċċin ma gew identifikati għall- vaċċini ta 'HPV.
The antibody response to HPV-16 and HPV-18 was measured using a type-specific ELISA which was shown to correlate with the pseudovirion-based neutralisation assay.
Ir- rispons ta ’ anti- korpi għal HPV- 16 u HPV- 18 ġie mkejjel b’ ELISA speċifiku għat- tip li wera li kkorrelata ma ’ l- analiżi ta ’ newtralizzazzjoni ibbażata fuq pseudovirion.
The immunogenicity induced by three doses of Cervarix has been evaluated in 5,303 female subjects from 10 to 55 years of age.
L- immunoġeneċita` ikkawżata minn tliet dożi ta ’ Cervarix ġiet evalwata f’ 5, 303 suġġetti nisa mill- eta` ta ’ 10 snin sa 55 sena.
In clinical trials, 99.9% of initially seronegative subjects had seroconverted to both HPV types 16 and 18 one month after the third dose.
7 Fi provi kliniċi, 99. 9% ta ’ suġġetti li għall- bidu kienu seronegattivi ġew serokonvertiti kemm għall - HPV tip 16 u kemm għall- HPV tip 18 xahar wara t- tielet doża.
Vaccine-induced IgG Geometric Mean Titres (GMT) were well above titres observed in women previously infected but who cleared HPV infection (natural infection).
IgG Geometric Mean Titres (GMT) ikkawżati mill- vaċċin kienu ogħla minn titres osservati f’ nisa li qabel kienu infettati iżda li nħelsu mill- infezzjoni HPV (infezzjoni naturali).
Initially seropositive and seronegative subjects reached similar titres after vaccination.
Suġġetti li għall- bidu kienu seropożittivi u seronegattivi waslu biex kellhom titres bħal dawk wara l- vaċċinazzjoni.
Study 001/ 007, which included women from 15 to 25 years of age at the time of vaccination, evaluated the immune response against HPV-16 and HPV-18 up to 76 months post dose 1.
L- istudju 001/ 007, li inkluda nisa minn 15 sa 25 sena fiż- żmien tal- vaċċinazzjoni, evalwa ir- rispons ta ’ l- immunità kontra HPV- 16 u HPV- 18 sa 76 xahar wara doża 1.
Vaccine-induced IgG Geometric Mean Titres (GMT) for both HPV-16 and HPV-18 peaked at month 7 and then declined to reach a plateau from month 18 up to the end of the follow-up (month 76).
IgG Geometric Mean Titres (GMT) ikkawżati mill- vaċċin kemm għall- HPV- 16 u kemm għall- HPV- 18 laħqu l- ogħla tagħhom fis- seba ’ xahar u mbagħad bdew jonqsu sa ma laħqu plateau mit- 18- il xahar sa l- aħħar tal- proċess kollu (s- 76 xahar).
At the end of the follow-up period, GMTs for both HPV-16 and HPV-18 were still at least 11-fold higher than titres observed in women previously infected but who cleared HPV infection and > 98% of the women were still seropositive for both antigens.
Fl- aħħar tal- perijodu tal- proċess kollu, GMTs kemm għall- HPV- 16 u kemm għall- HPV- 18 kienu għadhom mill- inqas 11- il darba aktar minn titres osservati f’ nisa li qabel kienu infettati iżda li ħelsu mill- infezzjoni HPV u > 98% tan- nisa kienu għadhom seroposittivi għaż- żewġ antiġeni.
In study 008, immunogenicity at month 7 was similar to the response observed in study 001.
Fl - istudju HPV- 008, l- immunoġeneċita` fis- seba ’ xahar kienet l- istess bħar- rispons osservat fl- istudju 001.
In another clinical trial (study 014) performed in women aged 15 to 55 years, all subjects seroconverted to both HPV types 16 and 18 after the third dose (at month 7).
Fi studju kliniku ieħor (studju 014) li sar f’ nisa ta ’ bejn is- 15 u l- 55 sena, is- suġġetti kollha serokkonvertew għaż- żewġ tipi ta ’ HPV 16 u 18 wara t- tielet doża (fis- 7 xahar).
The GMTs were, however, lower in women above 25 years.
Madankollu, il- GMT kienu anqas f’ nisa ta ’ il- fuq minn 25 sena.
Nevertheless, all subjects remained seropositive for both types throughout the follow-up phase (up to month 18) maintaining antibody levels at an order of magnitude above those encountered after natural infection.
Madankollu, is- suġġetti kollha baqgħu seropożittivi għaż - żewġ tipi matul il- fażi kollu tal- follow- up (sat- 18 il- xahar) u b’ hekk żammew livelli tal anti- korpi akbar minn dawk li tiltaqa ’ magħhom wara infezzjoni naturali.
7 Bridging the efficacy of Cervarix from young adult women to adolescents
Tnaqqis tad- differenza fl- effikaċja ta ’ Cervarix minn nisa żgħażagħ sa adolexxenti
In two clinical trials performed in girls and adolescents aged 10 to 14 years, all subjects seroconverted to both HPV types 16 and 18 after the third dose (at month 7) with GMTs at least 2-fold higher as compared to women aged 15 to 25 years.
F‘ żewġ provi kliniċi li saru fuq bniet u adolexxenti ta ’ bejn l- 10 snin sa 14- il sena, is- suġġetti kollha ġew serokonvertiti kemm għall- HPV- 16 u kemm għall- HPV- 18 wara t- tielet doża (fis- seba ’ xahar) b’ GMTs mill- inqas darbtejn ogħla meta mqabbla ma ’ nisa mill- eta` ta ’ 15 sa 25 sena.
On the basis of these immunogenicity data, the efficacy of Cervarix is inferred from 10 to 14 years of age.
Fuq il- bażi ta ’ tagħrif dwar l- immunoġeneċita`, jista ’ jiġi konkluż li l- effikaċja ta ’ Cervarix toħroġ ukoll mill- eta` ta ’ bejn l- 10 snin u l- 14 il- sena.
Evaluation of pharmacokinetic properties is not required for vaccines.
Fil- każ ta ’ vaċċini mhijiex meħtieġa l- evalwazzjoni ta ’ tagħrif farmakokinetiku.
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).
Informazzjoni mhux klinika, magħmula fuq studji konvenzjonali ta ’ sigurtà farmakoloġika, effett tossiku akut u minn dożi ripetuti, tolleranza lokali, fertilita`, effett tossiku fuq l- embriju/ fetu u wara t - twelid (sa tmiem il- perjodu tat- treddigħ), ma ’ turi l- ebda periklu speċjali għall- bnedmin.
Serological data suggest a transfer of anti-HPV-16 and anti-HPV-18 antibodies via the milk during the lactation period in rats.
Informazzjoni seroloġika turi transfer ta ’ anti- korpi anti- HPV- 16 u anti- HPV- 18 mill- ħalib waqt il - perjodu ta ’ treddigħ fil- firien.
However, it is unknown whether vaccine-induced antibodies are excreted in human breast milk.
Madankollu, m’ huwiex magħruf jekk l- anti- korpi li jistimula il- vaċċin joħorġux fil- ħalib tas- sider uman.
PHARMACEUTICAL PARTICULARS
TAGĦRIF FARMAĊEWTIKU 6.
Sodium chloride (NaCl) Sodium dihydrogen phosphate dihydrate (NaH2PO4.2 H2O) Water for injections
Sodium chloride (NaC1) Sodium dihydrogen phosphate dihydrate (NaH2PO4. 2 H2O) Ilma għall- injezzjonijiet
For adjuvants, see section 2.
Dwar sustanzi li jsaħħu (adjuvants), ara sezzjoni 2.
6.2 Incompatibilities
8 6. 2 Inkompatibilitajiet
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Minħabba li ma sarux studji li juru liema huma l- prodotti li ma jablux miegħu, dan il- prodott mediċinali m’ għandux jitħallat ma ’ prodotti mediċinali oħrajn.
Store in a refrigerator (2°C – 8°C).
Aħżen fi friġġ (2°Ċ – 8°Ċ).
Store in the original package in order to protect from light.
Tiffriżax Aħżen fil- pakkett oriġinali biex tħarsu mid- dawl.
0.5 ml of suspension in a vial (type I glass) for 1 dose with a stopper (rubber butyl) in pack sizes of 1, 10 and 100.
0. 5 ml suspensjoni f’ kunjett (tip I tal- ħġieġ) għal doża 1 b’ tapp (butyl rubber) f’ pakketti ta ’ 1, 10 u 100 kunjett.
8 A fine white deposit with a clear colourless supernatant may be observed upon storage of the vial.
Depożitu fin abjad b’ likwidu ċar u bla kulur jgħum fil- wiċċ jista ’ jidher waqt li l- kunjett ikun maħżun.
This does not constitute a sign of deterioration.
Dan ma jfissirx li qed jitħassar.
The content of the vial should be inspected visually both before and after shaking for any foreign particulate matter and/ or abnormal physical appearance prior to administration.
Il- kontenut tal- kunjett għandu jiġi ċċekkjat viżwalment kemm qabel u wara li jitħawwad għal xi partiċelli barranin u/ jew xi dehra fiżika mhux normali qabel ma ’ jingħata.
In the event of either being observed, discard the vaccine.
Jekk tkun osservata xi waħda minn dawn, il- vaċċin għandu jintrema.
The vaccine should be well shaken before use.
Ħawwad il- vaċċin sew qabel tużah.
DATE OF FIRST AUTHORISATION/ RENEWAL OF THE AUTHORISATION
DATA TA ’ L- EWWEL AWTORIZZAZZJONI/ TIĠDID TA ’ L - AWTORIZZAZZJONI
20 September 2007.
20 ta ’ Settembru 2007.
Cervarix suspension for injection, multidose Human Papillomavirus vaccine [Types 16, 18] (Recombinant, adjuvanted, adsorbed)
Cervarix, suspensjoni għall- injezzjoni, b’ ħafna dozi Vaċċin tal- Papillomavirus Uman [Tipi 16, 18] (Rikombinanti, imsaħħaħ, adsorbit)
adsorbed on aluminium hydroxide, hydrated (Al(OH)3) 4
Proteina 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 Rix4446 derivati minn Trichoplusia ni.
0.5 milligrams Al3+ in total
Ara sezzjoni 6. 5 għan- numru ta ’ dożi f’ kull kunjett.
10 The need for a booster dose has not been established (see section 5.1).
11 Il- ħtieġa ta ’ doża booster ma ġietx stabbilita (ara s- sezzjoni 5. 1)
It is recommended that subjects who receive a first dose of Cervarix complete the 3-dose vaccination course with Cervarix (see section 4.4).
Hu rrakkomandat li suġġetti li jirċievu l- ewwel doża ta ’ Cervarix jispiċċaw il- kors ta ’ tilqim fi 3 dożi b' Cervarix (ara sezzjoni 4. 4).
There are no safety, immunogenicity or efficacy data to support interchangeability of Cervarix with other HPV vaccines.
12 sostituzzjoni ta ’ Cervarix b’ vaċċini oħra ta 'HPV.
11 In all clinical trials individuals who had received immunoglobulin or blood products within 3 months prior to the first vaccine dose were excluded.
Fl- istudji kliniċi kollha kienu esklużi individwi li kienu ingħataw immunoglobulins jew prodotti tad - demm fit- 3 xhur ta ’ qabel l- ewwel vaċċin.
Use with other vaccines
Użu ma ’ vaċċini oħra
Adverse reactions considered as being at least possibly related to vaccination have been categorised by frequency.
13 Reazzjonijiet avversi kkunsidrati li huma possibilment relatati mal- vaċċinazzjoni ġew kategorizzati skond il- frekwenza.
12 Frequencies are reported as:
Il- frekwenzi huma rappurtati bħala:
Very common (≥ 1/ 10) Common (≥ 1/ 100 to < 1/ 10) Uncommon (≥ 1/ 1,000 to < 1/ 100)
Komuni ħafna (≥1/ 10) Komuni (≥1/ 100 to < 1/ 10) Mhux komuni (≥1/ 1, 000 to < 1/ 100)
Clinical studies
14 Studji kliniċi
Study 008
15 Studju 008
CIN2+ (primary endpoint)
(97. 9% CI) CIN2+ (endpoint primarju)
12-month persistent infection (secondary endpoint)
Infezzjoni persistenti wara 12 il- xahar (endpoint sekondarju) HPV- 16 and/ or 18 * HPV- 16 HPV- 18
14 All endpoints reached statistical significance for HPV-16.
L- endpoints kollha laħqu importanza statistika għal HPV- 16.
For HPV-18, the difference between the vaccine and control groups was not statistically significant for CIN2+ and 12 month persistent infection (TVC-1 cohort).
Għal HPV- 18, id- differenza bejn il - grupp tal- vaċċin u l- kontroll ma kienetx statistikament importanti għal CIN2+ u infezzjoni persistenti wara 12 il- xahar (cohort TVC- 1).
However, in a pre-specified analysis (TVC-2) that was identical to the TVC-1 analysis except that it excluded women with abnormal cytology at study entry, the 12 month persistent infection endpoint for HPV-18 reached statistical significance with vaccine efficacy of 89.9% (97.9% CI:
Madankollu, f’ analiżi speċifikata minn qabel (TVC- 2), li kienet l - istess bħall- analiżi TVC- 1 barra l- fatt li eskludiet nisa b’ ċitoloġija mhux normali fid- dħul ta ’ l- istudju, l- endpoint għal infezzjoni persistenti wara 12 il- xahar għal HPV- 18 laħqet importanza statistika b’ effikaċja tal- vaċċin ta ’ 89. 9% (97. 9% CI:
In clinical trials, 99.9% of initially seronegative subjects had seroconverted to both HPV types 16 and 18 one month after the third dose.
16 Fi provi kliniċi, 99. 9% ta ’ suġġetti li għall- bidu kienu seronegattivi ġew serokonvertiti kemm għall - HPV tip 16 u kemm għall- HPV tip 18 xahar wara t- tielet doża.
The GMTs were,
Fi studju kliniku ieħor (studju 014) li sar f’ nisa ta ’ bejn is- 15 u l- 55 sena, is- suġġetti kollha serokkonvertew għaż- żewġ tipi ta ’ HPV 16 u 18 wara t- tielet doża (fis- 7 xahar).
15 however, lower in women above 25 years.
Madankollu, il- GMT kienu anqas f’ nisa ta ’ il- fuq minn 25 sena.
Bridging the efficacy of Cervarix from young adult women to adolescents
Tnaqqis tad- differenza fl- effikaċja ta ’ Cervarix minn nisa żgħażagħ sa adolexxenti
6.2 Incompatibilities
17 6. 2 Inkompatibilitajiet
After first opening, immediate use is recommended.
Huwa rakkomandat li jintuża immedjatament kif jinfetah.
If not used immediately, the vaccine should be stored in a refrigerator (2°C – 8°C).
Jekk ma jintużax immedjatament, il- vaċċin għandu jinħażen fi friġġ (2°Ċ – 8°Ċ).
If not used within 6 hours it should be discarded.
Jekk ma jintużax fi żmien 6 sigħat għandu jintrema.
For storage after first opening, see section 6.3.
Għall- ħażna wara li jinfetah għall- ewwel darba, ara sezzjoni 6. 3.
16 1 ml of suspension in a vial (type I glass) for 2 doses with a stopper (rubber butyl) in pack sizes of 1, 10 and 100.
1 ml suspensjoni f’ kunjett (tip I tal- ħġieġ) għal 2 dożi b’ tapp (butyl rubber) f’ pakketti ta ’ 1, 10 u 100.
A fine white deposit with a clear colourless supernatant may be observed upon storage of the vial.
Depożitu fin abjad b’ likwidu ċar u bla kulur jgħum fil- wiċċ jista ’ jidher waqt li l- kunjett ikun maħżun.
When using a multidose vial, each 0.5 ml dose should be withdrawn using a sterile needle and syringe; precautions should be taken to avoid contamination of the contents.
Meta jintuża kontenitur b’ ħafna dożi, kull doża ta ’ 0. 5 ml għandha tinġibed b’ labra u siringa sterilizzati; għandhom jittieħdu prekawzjonijiet biex ma jkunx hemm kontaminazzjoni tal- kontenut.
Cervarix suspension for injection in pre-filled syringe Human Papillomavirus vaccine [Types 16, 18] (Recombinant, adjuvanted, adsorbed)
Vaċċin tal- Papillomavirus Uman [Tipi 16 u 18] (Rikombinanti, imsaħħaħ, adsorbit)
QUALITATIVE AND QUANTITATIVE COMPOSITION
GĦAMLA KWANTITATTIVA U KWANTITATTIVA
3-O-desacyl-4’ - monophosphoryl lipid A (MPL)3 3
3- O- desacyl- 4 ’ - monophosphoryl lipid A (MPL) 3 3 adsorbit fuq aluminium hydroxide idratat, (Al( OH) 3) 4
0.5 milligrams Al3+ in total
Proteina L1 f’ għamla ta ’ partiċelli mhux infettivi qieshom virus (VLP’ s) prodotta bl- użu ta ’ teknoloġija rikombinanti ta ’ DNA bl- użu ta ’ sistema ta ’ espressjoni Baculovirus li tuża ċelluli Hi- 5 Rix4446 derivati minn Trichoplusia ni.
For a full list of excipients, see section 6.1.
Għall- lista kompleta ta ’ sustanzi mhux attivi, ara sezzjoni 6. 1.
Suspension for injection in pre-filled syringe.
Suspensjoni għall- injezzjoni f’ siringa mimlija minn qabel.
Turbid white suspension.
Suspensjoni bajda, mdardra.
Upon storage, a fine white deposit with a clear colourless supernatant may be observed.
Meta jinħażen, jista ’ jrabbi depożitu rqiq u abjad b’ sustanza ċara bla kulur fil- wiċċ.
The need for a booster dose has not been established (see section 5.1).
Il- ħtieġa ta ’ doża booster ma ġietx stabbilita (ara sezzjoni 5. 1)
18 It is recommended that subjects who receive a first dose of Cervarix complete the 3-dose vaccination course with Cervarix (see section 4.4).
20 Hu rrakkomandat li suġġetti li jirċievu l- ewwel doża ta ’ Cervarix jispiċċaw il- kors ta ’ tilqim fi 3 dożi b' Cervarix (ara sezzjoni 4. 4).
Cervarix is for intramuscular injection in the deltoid region (see also sections 4.4 and 4.5).
Cervarix qiegħed għal injezzjoni fil- muskoli fir- reġjun tad- deltojde (ara wkoll sezzjonijiet 4. 4 u 4. 5).
However, the presence of a minor infection, such as a cold, is not a contraindication for immunisation.
Madankollu, meta jkun hemm xi infezzjoni żgħira, bħal xi riħ, m’ għandux ikun kontra- indikat għall - immunizzazzjoni.
As with other vaccines administered intramuscularly, Cervarix should be given with caution to individuals with thrombocytopenia or any coagulation disorder since bleeding may occur following an intramuscular administration to these subjects.
Bħal vaċċini oħra li jingħataw gol- muskoli, Cervarix għandu jingħata b’ attenzjoni lil individwi bi tromboċitopenija jew b’ xi problema ta ’ koagulazzjoni għax jista ’ jkun hemm ħruġ ta ’ demm wara li jingħata ġol- muskoli f’ suġġetti bħal dawn.
The vaccine is therefore not indicated for treatment of cervical cancer, cervical intraepithelial neoplasia (CIN) or any other established HPV- related lesions.
Għalhekk il- vaċċin m' huwiex indikat għall - kura tal- kanċer tal- għonq ta 'l- utru, neoplażja ġewwa ċ- ċellula epitelja tal- għonq tal- utru (CIN) jew xi leżjoni stabbilita relatata ma ’ HPV.
There are no safety, immunogenicity or efficacy data to support interchangeability of Cervarix with other HPV vaccines.
Ma hemmx informazzjoni fuq is- sigurtà, l- immunoġeniċità jew l- effikaċja biex issostni is- sostituzzjoni ta ’ Cervarix b’ vaċċini oħra ta 'HPV.
4.5 Interaction with other medicinal products and other forms of interaction
21 4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarjiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
19 Use with other vaccines
Użu ma ’ vaċċini oħra
There is no evidence that the use of hormonal contraceptives has an impact on the efficacy of Cervarix.
M’ hemmx evidenza li l- użu ta ’ kontraċettivi ta ’ l- ormoni għandu xi mpatt fuq l- effikaċja ta ’ Cervarix.
Use with systemic immunosuppressive medicinal products
Użu ma ’ mediċini immunosoppressivi sistemiċi
As with other vaccines it may be expected that, in patients receiving immunosuppressive treatment, an adequate response may not be elicited.
Bħal fil- każ ta ’ vaċċini oħra hu mistenni illi, f’ pazjenti fuq kura immunosoppressiva, jista ’ ma jkunx hemm rispons biżżejjed.
Cervarix should only be used during breast-feeding when the possible advantages outweigh the possible risks.
Waqt li mara tkun qed tredda ’ Cervarix għandu jingħata biss meta l- vantaġġi mistennija ikunu akbar mir- riskji involuti.
In a pre-defined subset of subjects (Cervarix = 8,130 versus control = 5,786), adverse events were followed for 30 days after each injection.
F’ sub- grupp sekondarju ta ’ suġġetti definit minn qabel (Cervarix = 8, 130 kontra kontroll = 5, 786) eventi avversi ġew segwiti għal 30 ġurnata wara kull tilqima.
Adverse reactions considered as being at least possibly related to vaccination have been categorised by frequency.
22 Reazzjonijiet avversi kkunsidrati li huma possibilment relatati mal- vaċċinazzjoni ġew kategorizzati skond il- frekwenza tagħhom..
Very common (≥ 1/ 10)
Il- frekwenzi huma rappurtati hekk:
20 Common (≥ 1/ 100 to < 1/ 10) Uncommon (≥ 1/ 1,000 to < 1/ 100)
Komuni ħafna (≥1/ 10) Komuni (≥1/ 100 to < 1/ 10) Mhux komuni (≥1/ 1, 000 to < 1/ 100)
Nervous system disorders:
Disturbi tas- sistema nervuża:
No case of overdose has been reported.
Ma ġie rrapurtat l- ebda każ ta ’ doża eċċessiva.
Cervarix is a non-infectious recombinant vaccine prepared from the highly purified virus-like particles (VLPs) of the major capsid L1 protein of oncogenic HPV types 16 and 18.
Cervarix hu vaċċin rekombinanti mhux infettiv magħmul mill- partiċelli qishom virus (VLPs) ippurifikati ħafna tal- proteina maġġuri capsid L1 tat- tipi onkoġeniċi HPV 16 u 18.
Animal studies have shown that the efficacy of L1 VLP vaccines is largely mediated by the development of a humoral immune response.
Studji fuq annimali wrew li l- effikaċja tal- vaċċini VLP L1 hi fil- parti l- kbira megħjuna permezz ta’ l- iżvilupp ta ’ rispons immunitarju bil- produzzjoni ta ’ l- antikorpi
HPV-16 and HPV-18 are responsible for approximately 70% of cervical cancers across all regions worldwide.
HPV- 16 u HPV- 18 huma responsabbli għal bejn wieħed u ieħor 70% ta ’ kanċer fl- għonq ta ’ l- utru tul ir- reġjuni kollha tad- dinja.
Clinical studies
23 Studji kliniċi