qanastek/EMEA-V3 huggingface dataset:
If you stop using Silapo Do not to stop the treatment without consultation of your doctor.
Jekk tieqaf tuza Silapo
4.
189 4.
Like all medicines, Silapo can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Silapo jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
PRCA means the inability to produce enough red blood cells in the bone (see section “Take special care with Silapo”).
fiż- żona ta ’ tebqet il- għajn u tax- xufftejn (edema ta ’ Quincke) u reazzjonijiet allerġiċi li jixbhu lil xokk b’ sintomi ta ’ tnemnim, ħmura, ħakk, fawra u polz mgħaġġel.
Kidney patients – raised blood pressure which may require treatment with medicinal products or adjustment of the dosage of medicinal products you already take for high blood pressure.
f’ pazjenti waraperijodu ta ’ minn xhur sa snin ta ’ kura mogħtija minn taħt il- ġilda (injezzjoni taħt il- ġilda) bl- erythropojetini.
Your doctor may monitor your blood pressure regularly while you are using Silapo, particularly at the start of therapy. – Occlusion in the connection between artery and vein (shunt thrombosis) may occur especially if you have low blood pressure or if your arteriovenous fistula has complications.
PRCA tfisser in- nuqqas ta ’ kapaċità li l- ġisem tiegħek jipproduċi biżżejjed ċelluli ħomor tad- demm fl- għadam (ara s- sezzjoni “ Oqgħod attent ħafna b’ Silapo ”).
Cancer patients – blood clotting (thrombotic vascular events) (see section “Take special care with Silapo”). – increase of blood pressure.
- Okklużjoni fejn l- arterja tikkonnettja mal- vina (trombożi fix- xant) tista ’ sseħħ, speċjalment jekk
Therefore your haemoglobin-levels and your blood pressure should be controlled.
It- tabib tiegħek jista ’ jiċċekkja x- xant tiegħek u jordnalek prodott mediċinali biex tiġi evitata trombożi.
HOW TO STORE SILAPO
KIF TAĦŻEN SILAPO
Keep out of the reach and sight of children.
190 Żomm fejn ma jintlaħaqx u ma jidhirx mit- tfal.
Do not use Silapo after the expiry date which is stated on the label and the carton.
Tużax Silapo wara d- data ta ’ skadenza li tidher fuq it- tikketta u l- kaxxa wara “ JIS ”.
Keep the pre-filled syringe in the outer carton in order to protect from light.
Is- siringa tista ’ titneħħa mill- friġġ u tista ’ titħalla f’ temperatura tal- kamra għal perjodu wieħed ta ’ mhux aktar minn 3 ijiem (iżda mhux f’ aktar minn 25°C).
The syringe can be removed from the refrigerator and left at room temperature for a single period of maximum 3 days (but not above 25°C).
Żomm is- siringa mimlija għal- lest fil- kartuna ta ’ barra sabiex tilqa ’ mid- dawl.
What Silapo contains
X’ fih Silapo
– The active substance is epoetin zeta (produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cell line.
Is- sustanza attiva hi l- epoetin zeta (magħmul permezz tat- teknoloġija tar- rikombinant DNA fil - – linja taċ- ċellula fil- CHO).
Silapo 1000 IU/0.3ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.3 ml solution for injection contains 1000 international units (IU) epoetin zeta (recombinant human erythropoietin).
Silapo 1000 IU/ 0. 3 ml soluzzjoni għall- injezzjoni f’ siringa mimlija minn qabel Siringa waħda mimlija minn qabel b’ 0. 3 ml soluzzjoni għall- injezzjoni fiha 1000 unit internazzjonali (IU) ta ’ l- epoetin zeta (rikombinant uman eritroptejin).
Silapo 2000 IU/0.6ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.6 ml solution for injection contains 2000 international units (IU) epoetin zeta (recombinant human erythropoietin).
Silapo 2000 IU/ 0. 6 ml soluzzjoni għall- injezzjoni f’ siringa mimlija minn qabel Siringa waħda mimlija minn qabel b’ 0. 6 ml soluzzjoni għall- injezzjoni fiha 2000 unit internazzjonali (IU) ta ’ l- epoetin zeta (rikombinant uman eritroptejin).
Silapo 3000 IU/0.9ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.9 ml solution for injection contains 3000 international units (IU) epoetin zeta (recombinant human erythropoietin).
Silapo 3000 IU/ 0. 9 ml soluzzjoni għall- injezzjoni f’ siringa mimlija minn qabel Siringa waħda mimlija minn qabel b’ 0. 9 ml soluzzjoni għall- injezzjoni fiha 3000 unit internazzjonali (IU) ta ’ l- epoetin zeta (rikombinant uman eritroptejin).
Silapo 4000 IU/0.4ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.4 ml solution for injection contains 4000 international units (IU) epoetin zeta (recombinant human erythropoietin).
Silapo 4000 IU/ 0. 4 ml soluzzjoni għall- injezzjoni f’ siringa mimlija minn qabel Siringa waħda mimlija minn qabel b’ 0. 4 ml soluzzjoni għall- injezzjoni fiha 4000 unit internazzjonali (IU) ta ’ l- epoetin zeta (rikombinant uman eritroptejin).
Silapo 5000 IU/0.5ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.5 ml solution for injection contains 5000 international units (IU) epoetin zeta (recombinant human erythropoietin).
Silapo 5000 IU/ 0. 5 ml soluzzjoni għall- injezzjoni f’ siringa mimlija minn qabel Siringa waħda mimlija minn qabel b’ 0. 5 ml soluzzjoni għall- injezzjoni fiha 5000 unit internazzjonali (IU) ta ’ l- epoetin zeta (rikombinant uman eritroptejin).
Silapo 6000 IU/0.6ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.6 ml solution for injection contains 6000 international units (IU) epoetin zeta (recombinant human erythropoietin).
Silapo 6000 IU/ 0. 6 ml soluzzjoni għall- injezzjoni f’ siringa mimlija minn qabel Siringa waħda mimlija minn qabel b’ 0. 6 ml soluzzjoni għall- injezzjoni fiha 6000 unit internazzjonali (IU) ta ’ l- epoetin zeta (rikombinant uman eritroptejin).
Silapo 8000 IU/0.8ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.8 ml solution for injection contains 8000 international units (IU) epoetin zeta (recombinant human erythropoietin).
Silapo 8000 IU/ 0. 8 ml soluzzjoni għall- injezzjoni f’ siringa mimlija minn qabel Siringa waħda mimlija minn qabel b’ 0. 8 ml soluzzjoni għall- injezzjoni fiha 8000 unit
Silapo 10000 IU/1.0ml solution for injection in pre-filled syringe 1 pre-filled syringe with 1.0 ml solution for injection contains 10000 international units (IU) epoetin zeta (recombinant human erythropoietin).
Silapo 10000 IU/ 1. 0 ml soluzzjoni għall- injezzjoni f’ siringa mimlija minn qabel Siringa waħda mimlija minn qabel b’ 1. 0 ml soluzzjoni għall- injezzjoni fiha 10000 unit internazzjonali (IU) ta ’ l- epoetin zeta (rikombinant uman eritroptejin).
Silapo 20000 IU/0.5ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.5 ml solution for injection contains 20000 international units (IU) epoetin zeta (recombinant human erythropoietin).
Silapo 20000 IU/ 0. 5 ml soluzzjoni għall- injezzjoni f’ siringa mimlija minn qabel Siringa waħda mimlija minn qabel b’ 0. 5 ml soluzzjoni għall- injezzjoni fiha 20000 unit internazzjonali (IU) ta ’ l- epoetin zeta (rikombinant uman eritroptejin).
Silapo 30000 IU/0.75ml solution for injection in pre-filled syringe 1 pre-filled syringe with 0.75 ml solution for injection contains 30000 international units (IU) epoetin zeta (recombinant human erythropoietin).
Silapo 30000 IU/ 0. 75 ml soluzzjoni għall- injezzjoni f’ siringa mimlija minn qabel Siringa waħda mimlija minn qabel b’ 0. 75 ml soluzzjoni għall- injezzjoni fiha 30000 unit internazzjonali (IU) ta ’ l- epoetin zeta (rikombinant uman eritroptejin).
191 Silapo 40000 IU/1.0ml solution for injection in pre-filled syringe 1 pre-filled syringe with 1.0 ml solution for injection contains 40000 international units (IU) epoetin zeta (recombinant human erythropoietin).
Silapo 40000 IU/ 1. 0 ml soluzzjoni għall- injezzjoni f’ siringa mimlija minn qabel Siringa waħda mimlija minn qabel b’ 1. 0 ml soluzzjoni għall- injezzjoni fiha 40000 unit internazzjonali (IU) ta ’ l- epoetin zeta (rikombinant uman eritroptejin).
The other ingredients are disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate, sodium chloride, calcium chloride dihydrate, polysorbate 20, glycine, leucine, isoleucine, threonine, glutamic acid, phenylalanine, water for injections, sodium hydroxide (pH adjuster), hydrochloric acid (pH adjuster).
Is- sustanzi l- oħra huma disodium phosphate dihydrate, sodium dihydrogen phosphate dihydrate, sodium chloride, calcium chloride dihydrate, polysorbate 20, glycine, leucine, isoleucine, threonine, glutamic acid, phenylalanine, water for injections, sodium hydroxide (għal aġġustament tal- pH), hydrochloric acid (għal aġġustament tal- pH).
What Silapo looks like and contents of the pack
Id- Dehra ta ’ Silapo u l- kontenuti tal- pakkett:
Silapo is presented as a clear and colourless solution for injection in a pre-filled syringe with a fixed injection needle.
Jintela f’ siringi ċari tal- ħġieġ b’ labra fissa għall- injezzjoni.
The pre-filled syringes contain between 0.3 and 1.0 ml solution, depending on the content of epoetin zeta (see “What Silapo contains”).
Is- siringi mimlija minn qabel fihom bejn 0. 3 u 1. 0 ml ta ’ soluzzjoni, skond il- kontenut ta ’ l- epoetin zeta (ara “ X’ fih Silapo ”).
One pack contains 1, 4 or 6 pre-filled syringes.
Pakkett wieħed għandu 1, 4 jew 6 siringi mimlija minn qabel.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
192 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq:
What is Silgard?
X’ inhu Silgard?
Silgard is a vaccine.
Silgard huwa vaċċin.
What is Silgard used for?
Għalxiex jintuża Silgard?
Silgard is used to vaccinate against precancerous lesions (abnormal cell growth) in the genital area (cervix, vulva or vagina), cancer of the cervix and genital warts that are caused by infection with the human papillomavirus (HPV) types 6, 11, 16 or 18. The effectiveness of Silgard has been studied in women aged 16 to 26 years, and its immunogenicity (its ability to make the immune system respond to the viruses) has been studied in children and adolescents aged nine to 15 years.
L- effikaċja ta ’ Silgard ġiet studjata f’ nisa b’ età ta ’ bejn 16 u 26 sena, u l- immunoġeniċità tiegħu (l- abbilità tiegħu li jġiegħel lis- sistema immunitarja tirrispondi għal vajrusijiet) ġiet studjata fi tfal u adoloxxenti b’ età ta ’ bejn disa ’ u 15- il sena.
Silgard is given according to official recommendations.
Silgard jingħata skond rakkomandazzjonijiet uffiċjali.
How is Silgard used?
Kif jintuża Silgard?
Silgard is given to individuals aged nine years or over, as three doses, with two months between the first and second doses, and four months between the second and third doses.
Silgard jingħata lill- individwi li għandhom disa ’ snin u iktar, bħala tliet dożi, b’ xahrejn bejn l- ewwel u t- tieni dożi, u erba ’ xhur bejn it- tieni u t- tielet doża.
It is recommended that individuals who receive the first dose of Silgard should complete all three doses with Silgard.
Huwa rrakkomandat li individwi li jirċievu l- ewwel doża ta ’ Silgard għandhom ikomplu t- tliet dożi kollha b’ Silgard.
How does Silgard work?
Kif jaħdem Silgard?
Papillomaviruses are viruses that cause warts and abnormal tissue growth.
Papillomavirusis huma vajrusijiet li jikkaġunaw felul u żvilupp anormali tat- tessuti.
Silgard contains the purified L1 proteins for four of the types of human papillomavirus: types 6, 11, 16, and 18.
Silgard fih proteini L1 ippurifikati ta ’ erba ’ tipi ta ’ papillomavirus tal- bniedem: tipi 6, 11, 16, u 18.
The proteins in Silgard are produced by a method known as ‘ recombinant DNA technology’: they are made by a yeast that has received a gene (DNA), which makes it able to produce the L1 proteins.
Huma magħmulin minn ħmira li tkun irċiviet ġene (DNA), li jagħmilha kapaċi tipproduċi l- proteini L1.
Reproduction is authorised provided the source is acknowledged. recognise them easily). The vaccine also contains an ‘ adjuvant ’ (a compound containing aluminium) to stimulate a better response.
Reproduction is authorised provided the source is acknowledged. ikun jista ’ jagħrafhom faċilment).
When a patient is given the vaccine, the immune system (the system that fights diseases) makes antibodies against these proteins.
Il- vaċċin fih ukoll ‘ aġġuvant ’ (taħlita li fiha l- aluminju) biex jistimola rispons aħjar.
The antibodies help to block the virus from entering cells in the body.
L- antikorpi jgħinu biex jimblokkaw il- vajrus milli jidħol fiċ- ċelloli tal- ġisem.
How has Silgard been studied?
Kif ġie studjat Silgard?
The effects of Silgard were first tested in experimental models before being studied in humans.
L- effetti ta ’ Silgard għall- ewwel ġew ittestjati fuq mudelli sperimentali qabel ma ġew studjati fuq il - bniedem.
The four main studies in humans involved almost 21,000 women aged between 16 and 26 years.
L- erba ’ studji ewlenin fuq il- bnedmin involvew kważi 21, 000 mara b’ età ta ’ bejn 16 u 26 sena.
Silgard was compared with placebo (a dummy vaccine).
Silgard tqabbel ma ’ plaċebo (vaċċin finta).
What benefit has Silgard shown during the studies?
Liema benefiċċju wera Silgard waqt l- istudji mwettqa?
Silgard was effective against precancerous genital lesions of the cervix, vulva and vagina, cervical cancer, and warts related to HPV types 6, 11, 16 and 18.
Silgard kien effettiv kontra leżjonijiet ġenitali ta ’ qabel il- kanċer taċ- ċerviċi, vulva u vaġina, kanċer taċ- ċerviċi, u felul relatat ma ’ HPV tipi 6, 11, 16 u18.
Looking at the results of all four studies together, in women who had never been infected by HPV types 6, 11, 16 or 18 before, and who received the full course of vaccination, one woman out of over 8,000 vaccinated with Silgard developed a precancerous lesion in the cervix that might have been due to HPV type 16 or 18.
Meta wieħed iħares lejn ir- riżultati ta ’ l- erba ’ studji flimkien, f’ nisa li qatt qabel ma kienu infettati b’ HPV tipi 6, 11, 16 jew18, u li rċievew il- kors sħiħ tat- tilqim, mara waħda minn aktar minn 8, 000 imlaqqma b’ Silgard żviluppat leżjoni ta ’ qabel il- kanċer fiċ- ċerviċi li setgħet seħħet minħabba HPV tip 16 jew 18.
A similar effect of Silgard was seen when the analysis also included lesions of the cervix due to the other two HPV types (types 6 and 11).
Effett simili ta ’ Silgard deher meta l- analiżi inkludew ukoll leżjonijiet taċ- ċerviċi minħabba ż- żewġ tipi l- oħra ta ’ HPV (tipi 6 u 11).
Two women out of almost 8,000 in the Silgard group developed genital warts, and there were no cases of precancerous lesions of the vulva or the vagina.
Fil- grupp ta ’ Silgard żewġ nisa minn kważi 8, 000 żviluppaw felul ġenitali, u ma kien hemm l- ebda każ ta ’ leżjonijiet ta ’ qabel il- kanċer tal- vulva u l- vaġina.
What is the risk associated with Silgard?
X’ inhu r- riskju assoċjat ma ’ Silgard?
In studies, the most common side effects with Silgard (seen in more than 1 patient in 10) were pyrexia (fever) and reactions at the site of the injection (redness, pain and swelling).
Fl- istudji, l- iktar effetti sekondarji komuni b’ Silgard (li dehru f' iktar minn pazjent 1 minn kull 10) kienu deni u reazzjonijiet fis- sit ta ’ l- injezzjoni (ħmura, uġigħ u nefħa).
For the full list of all side effects reported with Silgard, see the Package Leaflet.
Għal- lista sħiħa ta ’ effetti sekondarji kollha rrappurtati b’ Silgard, ara l- Fuljett ta ’ Tagħrif.
Silgard should not be used in people who may be hypersensitive (allergic) to the active substance or any of the other ingredients.
Silgard m’ għandux jintuża f’ nies li huma ipersensittivi (allerġiċi) għas- sustanza attiva jew għal xi sustanza oħra tiegħu.
If a patient shows signs of an allergy after a dose of Silgard, she should not receive further doses of the vaccine.
Jekk pazjenta turi sinjali ta ’ allerġija wara doża ta ’ Silgard, m’ għandhiex tingħata iktar dożi tal- vaċċin.
Why has Silgard been approved?
Għaliex ġie approvat Silgard?
The Committee for Medicinal Products for Human Use (CHMP) decided that Silgard’ s benefits are greater than its risks as a vaccine for the prevention of premalignant genital lesions (cervical, vulvar and vaginal), cervical cancer and external genital warts (condyloma acuminata) causally related to HPV types 6, 11, 16 and 18.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Silgard huma ikbar mir- riskji tiegħu għall- prevenzjoni ta ’ leżjonijiet ġenitali premalinni (ċervikali, vulvari u vaġinali), kanċer taċ- ċerviċi u felul ġenitali estern (kondiloma akuminata) kawżalment relatati ma ’ HPV tipi 6, 11, 16 u 18.
The Committee recommended that Silgard be given marketing authorisation.
Il- Kumitat irrakkomanda li Silgard jingħata awtorizzazzjoni għat - tqegħid fis- suq.
Other information about Silgard:
Informazzjoni oħra dwar Silgard:
The European Commission granted a marketing authorisation valid throughout the European Union for Silgard to Merck Sharp & Dohme Ltd. on 20 September 2006.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fuq is- suq madwar l- Unjoni Ewropea, għal Silgard lill- kumpanija Merck Sharp & Dohme Ltd. fl- 20 ta ’ Settembru 2006.
The full EPAR for Silgard can be found here.
L- EPAR sħiħ għal Silgard jista ’ jinstab hawn.
Pharmaceutical Form Suspension for injection Suspension for injection Suspension for injection Suspension for injection Suspension for injection
Sospensjoni għal injezzjoni
Route of Administration Intramuscular use Intramuscular use Intramuscular use Intramuscular use Intramuscular use
siringa mimlija għal- lest (ħġieġ)
Packaging vial (glass) vial (glass) pre-filled syringe (glass) pre-filled syringe (glass) pre-filled syringe (glass)
siringa mimlija għal- lest (ħġieġ)
Content 0.5 ml 0.5 ml 0.5 ml 0.5 ml 0.5 ml
10 siringi mimlijin għal- lest
Intramuscular use
Għal użu ġol - muskoli
10 pre-filled syringes with needle guard + 20 needles
20 siringa mimlija għal- lest b’ għant tal- labra + 40 labra
EU/ 1/ 06/ 358/ 017
EU/ 1/ 06/ 358/ 018
pre-filled syringe (glass)
kunjett (ħġieġ)
20 pre-filled syringes with needle guard + 40 needles
20 kunjett
Suspension for injection Suspension for injection
Sospensjoni għal injezzjoni
Intramuscular use Intramuscular use
Għal użu ġol - muskoli
vial (glass) pre-filled syringe (glass)
siringa mimlija għal- lest (ħġieġ)
20 vials 20 pre-filled syringes
20 siringa mimlija għal- lest
1 1 dose (0.5 ml) contains approximately:
1 doża 1 (0. 5 ml) fiha bejn wieħed u ieħor:
Silgard, suspension for injection.
Silgard, sospensjoni għall- injezzjoni.
2
Papillomavirus Uman1 Proteina tip 6 L12, 3 20 mikrogramma Papillomavirus Uman1 Proteina tip 11 L12, 3 40 mikrogramma Papillomavirus Uman1 Proteina tip 16 L12, 3 40 mikrogramma Papillomavirus Uman1 Proteina tip 18 L12, 3 20 mikrogramma 1 Papillomavirus Uman = HPV.
L1 protein in the form of virus-like particles produced in yeast cells (Saccharomyces cerevisiae CANADE 3C-5 (Strain 1895)) by recombinant DNA technology.
2 L1 proteina fis- sura ta 'partikuli qishom virus prodotti fiċ- ċelluli tal- moffa (Saccharomyces cerevisiae CANADE 3C- 5 (Speċi 1895)) minn teknoloġija DNA rikombinanti.
Prior to agitation, Silgard may appear as a clear liquid with a white precipitate.
Qabel ma jitħawwad, Silgard jista 'jidher bħala likwidu ċar bi preċipitat abjad.
Silgard is a vaccine for the prevention of premalignant genital lesions (cervical, vulvar and vaginal), cervical cancer and external genital warts (condyloma acuminata) causally related to Human Papillomavirus (HPV) types 6, 11, 16 and 18 (see section 5.1).
Silgard hu vaċċin għall- prevenzjoni ta ’ leżjonijiet ġenitali malinni minn qabel (ċervikali, vulvari u vaġinali), kanċer ċervikali u felul ġenitali esterni (condyloma acuminata) li l- kawża tiegħu hi marbuta mal- Papillomavirus Uman (HPV) tat- tipi 6, 11, 16 u 18 (ara sezzjoni 5, 1).
The indication is based on the demonstration of efficacy of Silgard in adult females 16 to 26 years of age and on the demonstration of immunogenicity of Silgard in 9- to 15-year old children and adolescents.
L- indikazzjoni hi bbażata fuq it- turija ta ’ l- effikaċja ta ’ Silgard f’ nisa adulti ta ’ età ta ’ bejn is- 16 u s- 26 sena u fuq it- turija ta ’ l- immunoġeniċità ta ’ Silgard fi tfal u adolexxenti ta ’ bejn id- 9 u l- 15- il sena.
Protective efficacy has not been evaluated in males (see section 5.1).
L - effikaċja protettiva ma kienitx evalwata fl- irġiel (ara sezzjoni 5. 1).
The use of Silgard should be in accordance with official recommendations.
Silgard għandu jintuża skond ir- rakkomandazzjonijiet uffiċjali.
Paediatric population:
2 Popolazzjoni pedjatrika.
2 insufficient data on immunogenicity, safety and efficacy (see section 5.1).
Silgard mhux rakkomandat għall- użu fit- tfal taħt il- 9 sena għax m’ hemmx biżżejjed informazzjoni dwar l- immunoġeniċità, is- sigurtà u l- effikaċja (ara sezzjoni 5. 1).
Silgard must not be injected intravascularly.
Silgard m’ għandux jiġi injettat intravaskularment.
It is recommended that subjects who receive a first dose of Silgard complete the 3-dose vaccination course with Silgard (see section 4.4).
Huwa rrakomandat li suġġetti li jirċievu l- ewwel doża ta ’ Silgard jtemmu l- kors ta ’ tilqim ta ’ 3 dożi b’ Silgard (ara sezzjoni 4. 4).
Individuals who develop symptoms indicative of hypersensitivity after receiving a dose of Silgard should not receive further doses of Silgard.
Individwi li jiżviluppaw sintomi ta ’ sensittività eċċessiva wara li jirċievu doża ta ’ Silgard m’ għandhomx jirċievu dożi addizzjonali ta ’ Silgard.
Administration of Silgard should be postponed in subjects suffering from an acute severe febrile illness.
L- għoti ta ’ Silgard għandu jkun pospost f’ pazjenti li jbatu minn mard b’ deni serju u akut.
Syncope (fainting) may follow any vaccination, especially in adolescents and young adults.
Wara kwalunkwe vaċċinazzjoni tista ’ sseħħ sinkope (ħass ħażin), b’ mod speċjali f’ adoloxxenti u żgħażagħ.
Syncope, sometimes associated with falling, has occurred after vaccination with Silgard (See section 4.8).
Sinkope, xi kultant assoċjata ma ’ waqgħat, seħħet wara vaċċinazzjoni b’ Silgard (Ara sezzjoni 4. 8).
Therefore, vaccinees should be carefully observed for approximately 15 minutes after administration of Silgard.
Għaldaqstant, dawk li jieħdu t- tilqima għandhom jiġu osservati għal madwar 15- il minuta wara l- għoti ta ’ Silgard.
As with any vaccine, vaccination with Silgard may not result in protection in all vaccine recipients.
Bħal kull vaċċin, it- tilqima b’ Silgard tista ’ ma tirriżultax fi protezzjoni għar- reċipjenti kollha tal - vaċċin.
Silgard will only protect against diseases that are caused by HPV types 6, 11, 16 and 18 and to a limited extent against diseases caused by certain related HPV types (See section 5.1).
Silgard ser jipproteġi biss kontra l- mard ikkawżat mit- tipi 6, 11, 16 u 18 tal- HPV u sa ċertu punt, kontra l- mard ikkawżat minn ċerti tipi ta ’ HPV relatati (ara sezzjoni 5. 1).
Silgard has not been shown to have a therapeutic effect.
Ma ntweriex li Silgard għandu effett terapewtiku.
It is also not intended to prevent progression of other established HPV-related lesions.
Silgard, ukoll, mhuwiex maħsub biex jevita l- progress ta ’ feriti oħra stabbiliti marbuta mal- HPV.
Since no vaccine is 100% effective and Silgard will not provide protection against every HPV type, or against existing HPV infections, routine cervical screening remains critically important and should follow local recommendations.
Peress li l- ebda vaċċin mhu effettiv 100% u Silgard mhux se jipprovdi protezzjoni kontra kull tip ta ’ HPV jew kontra infezzjonijiet HPV eżistenti, screening ċervikali ta ’ rutina jibqa ’ ta ’ importanza kritika u għandu jsegwi r- rakkomandazzjonijiet lokali.
There are no data on the use of Silgard in subjects with impaired immune responsiveness.
M’ hemm l- ebda informazzjoni dwar l- użu ta ’ Silgard f’ pazjenti bi ħsara fir- rispons tas- sistema immuni.
Sustained protective efficacy has been observed for 4.5 years after completion of the 3-dose series.
Effikaċja protettiva sostnuta kienet osservata għal 4. 5 snin wara li ntemmet serje ta ’ 3 dożi.
3 There are no safety, immunogenicity or efficacy data to support interchangeability of Silgard with other HPV vaccines.
Ma hemm ebda tagħrif dwar is- sigurtà, l- immunoġeniċità jew l- effikaċja li jappoġġja l- interkambjalità ta ’ Silgard ma ’ tilqim HPV ieħor.
Administration of Silgard at the same time (but, for injected vaccines, at a different injection site) as hepatitis B (recombinant) vaccine did not interfere with the immune response to the HPV types.
L- għoti ta ’ Silgard fl- istess ħin (iżda, għal vaċċini injettati, f’ sit ta 'l- injezzjoni differenti) bħal vaċċin ta ’ l- epatite B (rikombinanti) ma jinterferixxix mar- rispons immuni għat- tipi HPV.
The concomitant administration of Silgard with vaccines other than hepatitis B (recombinant) vaccine has not been studied.
L- għoti fl- istess ħin ta ’ Silgard ma ’ vaċċini oħrajn li mhumiex vaċċini ta ’ l- epatite B (rikombinanti) ma kienx studjat.
In clinical studies, 57.5% of women (age 16 to 26 years) who received Silgard used hormonal contraceptives.
Fi studji kliniċi, 57. 5% tan- nisa (ta ’ età bejn 16 u 26 sena) li rċivew Silgard użaw kontraċettivi ormonali.
Use of hormonal contraceptives did not appear to affect the immune response to Silgard.
Ma deherx li l- użu ta ’ kontraċettivi ormonali kellu effett fuq ir- rispons immuni għal Silgard.
There were no significant differences in types of anomalies or proportion of pregnancies with an adverse outcome in Silgard and placebo treated subjects.
Ma kien hemm ebda differenza sinifikanti f’ tipi ta ’ anomaliji jew proporzjonijiet ta ’ tqaliet b’ riżultat avvers f’ suġġetti ikkurati b’ Gardasil u f’ dawk ikkurati bi plaċebo.
The data on Silgard administered during pregnancy did not indicate any safety signal.
L- informazzjoni fuq Silgard mogħti waqt it- tqala ma tindikax l- ebda sinjal tas- sigurtà.
However, these data are insufficient to recommend use of Silgard during pregnancy.
Madankollu, din l- informazzjoni mhix biżżejjed biex ikun irrakkomandat l- użu ta ’ Silgard waqt it- tqala.
In breastfeeding mothers given Silgard or placebo during the vaccination period of the clinical trials the rates of adverse reactions in the mother and the breastfed infant were comparable between the vaccination and the placebo groups.
F’ nisa li kienu qed ireddgħu mogħtija Silgard jew plaċebo waqt il- perjodu tat- tilqima tal- provi kliniċi, ir- rati ta ’ reazzjonijiet avversi fl- omm u fit- tarbija mredda ’ kienu komparabbli bejn il- gruppi tal - vaċinazzjoni u dawk tal- plaċebo.
In addition, vaccine immunogenicity was comparable among breastfeeding mothers and women who did not breastfeed during the vaccine administration.
Flimkien ma 'dan, l- immunoġeniċità tal- vaċċin kienet komparabbli fost l- ommijiet li kienu jreddgħu u n- nisa li ma kienux qed ireddgħu waqt l- għoti tal- vaċċin.
Therefore Silgard can be given to breastfeeding women.
Għaldaqstant, Silgard jista ’ jingħata lil nisa li jreddgħu.
In 5 clinical trials (4 placebo-controlled), subjects were administered Silgard or placebo on the day of enrolment and approximately 2 and 6 months thereafter.
F’ 5 provi kliniċi (4 ikkontrollati bil- plaċebo), il- pazjenti ngħataw Silgard jew il- plaċebo fil- jum tar - reġistrazzjoni u madwar xahrejn u 6 xhur wara dan.
The subjects who were monitored using VRC-aided surveillance included 6,160 subjects (5,088 females 9 to 26 years of age and 1,072 males 9 to 15 years of age at enrolment) who received Silgard and 4,064 subjects who received placebo.
Is- sigurtà kienet evalwata jew fil- popolazzjoni studjata kollha (4 studji) jew f’ sett speċifiku definit minn qabel (studju wieħed) tal- popolazzjoni studjata bl- użu ta sorveljanza megħjuna b' kard ta ’ rappurtaġġ tat- tilqima (VRC) għal 14- il jum wara kull injezzjoni ta ’ Silgard jew tal- plaċebo Il- pazjenti li kienu mmonitorjati bl- użu ta ’ sorveljanza megħjuna bil- VRC inkludew 6, 160 pazjent (5, 088 mara, ta ’ età bejn 9 u 26 sena, u 1, 072 raġel ta ’ età bejn 9 u 15- il sena fiż- żmien tar - reġistrazzjoni) li rċivew Silgard u 4, 064 pazjent li rċevew il- plaċebo.
The following vaccine-related adverse reactions were observed among recipients of Silgard at a frequency of at least 1.0% and also at a greater frequency than observed among placebo recipients.
Ir- reazzjonijiet avversi li ġejjin, li kienu marbuta mal- vaċċin, kienu osservati fost ir- reċipjenti ta ’ Silgard fi frekwenza ta ’ mill- anqas 1. 0% u anke fi frekwenza akbar minn dik li kienet osservata fost ir - reċipjenti tal- plaċebo.
They are ranked under headings of frequency using the following convention:
Dawn huma kklassifikati taħt kategoriji ta 'frekwenza billi tintuża l- konvenzjoni li ġejja:
[Very Common (≥ 1/ 10); Common (≥ 1/ 100, < 1/ 10); Uncommon (≥ 1/ 1,000, < 1/ 100); Rare (≥ 1/ 10,000, < 1/ 1,000); Very Rare (< 1/ 10,000), including isolated reports]
[Komuni Ħafna (≥ 1/ 10); Komuni (≥ 1/ 100, < 1/ 10); Mhux Komuni (≥ 1/ 1, 000, < 1/ 100); Rari (≥ 1/ 10, 000, < 1/ 1, 000); Rari Ħafna (< 1/ 10, 000), inklużi rapporti iżolati]
Seven cases (0.06%) of urticaria were reported in the Silgard group and 17 cases (0.18%) were seen in the adjuvant-containing placebo group.
Seba ’ każijiet (0. 06%) ta ’ urtikarja kienu rrappurtati fil- grupp ta 'Silgard u 17- il każ (0. 18%) kienu osservati fil- grupp li kienet qed jingħata is- sustanza li kien fiha l- plaċebo.
Among 11,778 subjects who received Silgard and 9,686 subjects who received placebo, there were 28 cases of non-specific arthritis/ arthropathy reported, 20 in the Silgard group and 8 in the placebo group.
Fost il- 11, 778 pazjent li rċivew Silgard u 9, 686 pazjent li rċivew il - plaċebo, kien hemm 28 każ ta ’ artrite/ artropatija mhux speċifika li kienu rrappurtati, 20 fil- grupp ta ’ Silgard u 8 fil- grupp tal- plaċebo.
Post Marketing adverse events have been spontaneously reported for Silgard and are not listed above.
Episodji avversi ta ’ wara t- tqegħid fis- suq ġew irrapportati b’ mod spontanju għal Silgard u m’ humiex elenkati hawn fuq.
Because these events were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or to establish, for all events, a causal relationship to vaccine exposure.
Minħabba li dawn l- episodji ġew irrapportati b’ mod volontarju minn popolazzjoni ta ’ ċertu daqs, mhuwiex possibbli li l- frekwenza tagħhom tkun stmata b’ mod affidabbli jew li tkun stabbilita, għall - episodji kollha, relazzjoni kawżali għall- espożizzjoni tal- vaċċin.
Gastrointestinal disorders: nausea, vomiting.
5 Disturbi gastro- intestinali: nawsea, rimettar.
Musculoskeletal and connective tissue disorders: arthralgia, myalgia.
Disturbi muskuloskeletali u tal- connective tissue: artralġija, mijalġija.
General disorders and administration site conditions: asthenia, fatigue, malaise.
Disturbi ġenerali u kondizzjonijiet ta 'mnejn jingħata: astenja, għejja, ħass ħażin.
There have been reports of administration of higher than recommended doses of Silgard.
Kien hemm rapporti dwar l- għoti ta ’ doża ogħla mid- dożi rakkomandati ta ’ Silgard.
5 In general, the adverse event profile reported with overdose was comparable to recommended single doses of Silgard.
B’ mod ġenerali, il- profil ta ’ l- avvenimenti avversi rrapputati b’ doża eċċessiva kien komparabbli ma 'dak tad- doża waħidha rakkomandata ta ’ Silgard.
Silgard is an adjuvanted non-infectious recombinant quadrivalent vaccine prepared from the highly purified virus-like particles (VLPs) of the major capsid L1 protein of HPV types 6, 11, 16 and 18.
Silgard huwa vaċċin mhux infettuż, rikombinanti, kwadrivalenti, adjuvanted ippreparat minn partikuli qishom virus- like particles (VLPs) ippurifikati ħafna tal- proteina maġġuri kapsida L1 tat- tipi ta ’ HPV 6, 11, 16 u 18.
The efficacy of Silgard was assessed in 4 placebo-controlled, double-blind, randomized Phase II and III clinical studies including a total of 20,541 16- to 26-year old women, who were enrolled and vaccinated without pre-screening for the presence of HPV infection.
L- effikaċja ta ’ Silgard kienet evalwata f’ 4 provi kliniċi kkontrollati bil- plaċebo, double- blind, randomized ta ’ Fażi II u III, li kienu jinkludu total ta ’ 20, 541 mara ta ’ età ta 'bejn 16 u 26 sena, li kienu rreġistrati u vaċċinati mingħajr screening minn qabel, għall- preżenza ta ’ infezzjoni tal- HPV.
The median duration of follow-up for these studies was 4.0, 3.0, 3.0, and 3.0 years for Protocol 005, Protocol 007, Protocol 013, and Protocol 015, respectively.
6 3. 0, 3. 0, u 3. 0 snin għal Protokoll 005, Protokoll 007, Protokoll 013, u Protokoll 015, rispettivament.
Silgard was efficacious against HPV disease caused by each of the four vaccine HPV type.
Silgard kien effikaċji kontra l - mard tal- HPV ikkawżat minn kull wieħed mill- erba ’ tipi ta ’ vaċċin HPV.
Cervical Intraepithelial Neoplasia (CIN) Grade 2/ 3 (moderate to high-grade dysplasia) and adenocarcinoma in situ (AIS) were used in the clinical trials as a surrogate marker for cervical cancer.
In- Neoplasja Intraepiteljali Ċervikali (CIN) ta ’ Grad 2/ 3 (displasja moderata sa grad għoli) u adenokarċinoma in situ (AIS) intużaw fi provi kliniċi bħala indikazzjoni sostituttiva għall- kanċer ċervikali.
6 conducted in the per-protocol efficacy (PPE) population (n= all 3 vaccinations within 1 year of enrolment, no major protocol deviations and naïve to the relevant HPV type(s) prior to dose 1 and through 1 month Postdose 3 (Month 7)).
L- analiżi primarji ta ’ l- effikaċja, fir- rigward ta ’ tipi ta ’ vaċċini HPV (HPV 6, 11, 16, u 18), saru fil - popolazzjoni ta ’ l- effikaċja skond il- protokoll (PPE) (n= it- 3 tilqimiet kollha fi żmien sena mir - reġistrazzjoni, l- ebda devjazzjonijiet kbar mill- protokoll u naïve għat- tip( i) ta ’ HPV rilevanti qabel l- 1 doża u matul l- ewwel xahar tal- perjodu ta ’ Wara d- Doża 3 (Xahar 7)).
In a supplemental analysis, the efficacy of Silgard was evaluated against HPV 16/ 18-related CIN 3 and AIS.
F’ analiżi supplimentali, l- effikaċja ta ’ Silgard ġiet evalwata kontra CIN 3 u AIS relatati ma ’ HPV 16/ 18
Analysis of efficacy of Silgard against high grade cervical lesions in the PPE population
Analiżi ta 'l- effikaċja ta' Silgard kontra leżjonijiet ċervikali ta ’ grad għoli fil- popolazzjoni PPE
Silgard
Plaċebo Silgard
Efficacy***
Effikaċja ***
of cases of cases
ta ’
Efficacy of cases
ta ’
Number
Effikaċja
Number at 2 years Number Number
fl- aħħar tal -
Number Number at 2 years Number Number
każijiet
study
f’ sena 2
0 8487
96. 9
100 (86.5, 100.0)
2 **
AIS
(30. 6, 100. 0)
the efficacy of Silgard against HPV 6-, 11-, 16-, 18-related CIN 1 was 95.9% (95% CI:
l- effikaċja ta ’ Silgard kontra CIN 1 relatata ma ’ HPV 6 -, 11 -, 16 -, 18 kienet ta ’ 95. 9% (95% CI:
91.4, 98.4)
91. 4, 98. 4)
the efficacy of Silgard against HPV 6-, 11-, 16-, 18-related CIN (1, 2, 3) or AIS was 96.0% (95% CI:
l- effikaċja ta ’ Silgard kontra CIN (1, 2, 3) jew AIS relatata ma ’ HPV 6 -, 11 -, 16 -, 18 - kienet 96. 0% (95% CI:
the efficacy of Silgard against HPV 6-, 11-, 16-, 18-related VIN2/ 3 and VaIN 2/ 3 was 100% (95% CI:
l- effikaċja ta ’ Silgard kontra VIN2/ 3 u VaIN 2/ 3 relatata ma ’ HPV 6 -, 11 -, 16 -, 18 kienet 100% (95% CI:
the efficacy of Silgard against HPV 6-, 11-, 16-, 18-related genital warts was 99.0% (95% CI:
l- effikaċja ta ’ Silgard kontra felul ġenetali relatat ma ’ HPV 6 -, 11 -, 16 -, 18 kienet 99. 0% (95% CI:
In Protocol 012 the efficacy of Silgard against the 6 month definition of persistent infection [samples positive on two or more consecutive visits 6 months apart (±1 month) or longer] related to HPV 16 was 98.7% (95% CI:
Fi Protokoll 012, l- effikaċja ta ’ Silgard kontra d- definizzjoni ta ’ 6 xhur ta ’ infezzjoni persistenti [kampjuni pożittivi fuq żewġ żjarat konsekuttivi jew aktar b’ 6 xhur bejniethom (±1 xahar) jew aktar] relatati ma ’ HPV 16 kienet 98. 7% (95% CI:
7 Efficacy in individuals with evidence of HPV 6, 11, 16, or 18 infection or disease at day 1
Effikaċja f’ individwi b’ evidenza ta ’ infezzjoni jew marda b’ HPV 6, 11, 16 jew 18 fil- linja bażi f’ jum 1
Efficacy of Silgard in high grade cervical lesions in the modified ITT-population including women regardless of baseline HPV status
L- effikaċja ta ’ Silgard f’ leżjonijiet ċervikali ta ’ grad għoli fil- popolazzjoni ITT mibdula li tinkludi nisa irrispettivament mill- istat tal- linja bażi ta ’ HPV
at 2 years N
każijiet
subjects*
każijiet
(95% CI) of of
Numru ta ’
of (95% CI) of of
(95% CI)
(95% CI)
tal- istudju
HPV 16-or HPV
(95% CI)
46.0 (31.0, 57.9)
(31. 0, 57. 9)
HPV 16/ 18-
ma ’ HPV 16/ 18
*Number of subjects with at least one follow-up visit after 30 days after Day 1 **Percent efficacy is calculated from the combined protocols.
L- effikaċja għal CIN 2/ 3 jew
The efficacy for HPV 16/ 18 related CIN 2/ 3 or AIS is based on data from protocols 005 (16-related endpoints only), 007, 013, and 015.
8 AIS relatat ma ’ HPV 16/ 18 hija bbażata fuq it- tagħrif mill- protokolli 005 (16- il punt ta ’ tmiem relatat biss), 007, 013 u 015.
Protection Against the Overall Burden of Cervical HPV disease in 16- Through 26-Year-Old Women
Protezzjoni Kontra l- Piż Globali tal- marda HPV Ċervikali f’ Nisa ta ’ Bejn 16 u 26 Sena
The impact of Silgard against the overall risk for cervical, HPV disease (i. e., disease caused by any HPV type) was evaluated starting 30 days after the first dose in 17,599 subjects enrolled in the two phase III efficacy trials (Protocols 013 and 015).
L- impatt ta ’ Silgard fuq ir- rati ta ’ Proċeduri ta ’ Terapija Ċervikali Definittivi irrispettivament mit- tipi ta ’ HPV kawżali kien evalwat fi 18, 150 suġġett reġistrati fil- Protokoll 007, Protokolli 013 u 015.
Among subjects who were naïve to 14 common HPV types and had a negative Pap test at Day 1, administration of Silgard reduced the incidence of CIN 2/ 3 or AIS caused by vaccine- or non-vaccine HPV types by 42.7% (95% CI:
27. 7, 53. 5) fl- aħħar tal- istudju.
23.7, 57.3) and of genital warts by 82.8% (95% CI:
Fil- popolazzjoni ITT, it- tnaqqis korrespondenti kien 23. 9% (95% CI:
74.3, 88.8) at end of study.
15. 2, 31. 7.
In the modified ITT population, the benefit of the vaccine with respect to the overall incidence of CIN 8 2/ 3 or AIS (caused by any HPV type) and of genital warts was much lower, with a reduction of 18.4% (95% CI:
Fil- popolazzjoni ITT mibdula, il- benefiċċju tal- vaċċin fir- rigward ta ’ l- inċidenza globali ta ’ CIN 2/ 3 jew AIS (ikkawżata minn kwalunkwe tip ta ’ HPV) u ta ’ felul ġenitali kien ferm inqas, bi tnaqqis ta ’ 18. 4% (95% CI:
54.0, 69.5), respectively, as Silgard does not impact the course of infections or disease that are present at vaccination onset.
54. 0, 69. 5), rispettivament, minħabba li Silgard ma għandux impatt fuq il- kors ta ’ l- infezzjonijiet jew mard li jfeġġu mal- bidu tat- tilqima.
The impact of Silgard on rates of Definitive Cervical Therapy Procedures regardless of causal HPV types was evaluated in 18,150 subjects enrolled in Protocol 007, Protocols 013 and 015.
L- impatt ta ’ Silgard fuq ir- rati ta ’ Proċeduri ta ’ Terapija Ċervikali Definittivi irrispettivament mit- tipi ta ’ HPV kawżali kien evalwat fi 18, 150 suġġett reġistrati fil- Protokoll 007, Protokolli 013 u 015.
In the HPV naïve population (naïve to 14 common HPV types and had a negative Pap test at Day 1), Silgard reduced the proportion of women who experienced, a definitive cervical therapy procedure (Loop Electro-Excision Procedure or Cold-Knife Conization) by 41.9% (95% CI:
Fil- popolazzjoni ITT, it- tnaqqis korrespondenti kien 23. 9% (95% CI:
27.7, 53.5) at end of study.
15. 2, 31. 7).
The efficacy of Silgard against CIN (any grade) and CIN 2/ 3 or AIS caused by 10 non-vaccine HPV types (HPV 31, 33, 35, 39, 45, 51, 52, 56, 58, 59) structurally related to HPV 16 or HPV 18 was evaluated in the combined Phase III efficacy database (N = 17,599) after a median follow-up of 3.7 years (at end of study).
Effikaċja kross- protettiva L- effikaċja ta ’ Silgard kontra CIN (kull grad) u CIN 2/ 3 jew AIS ikkawżati minn 10 tipi ta ’ HPV mhux vaċċin (HPV 31, 33, 35, 39, 45, 51, 52, 56, 58, 59) strutturalment relatati ma ’ HPV 16 jew ma ’ HPV 18, ġiet evalwata fid- database kombinata ta ’ l- effikaċja ta ’ Fażi III (N = 17, 599) wara follow- up medjan ta ’ 3. 7 snin (fl- aħħar ta ’ l- istudju).
For composite endpoints, statistically significant efficacy against disease was demonstrated against HPV types phylogenetically related to HPV 16 (primarily HPV 31) whereas no statistically significant efficacy was observed for HPV types phylogenetically related to HPV 18 (including HPV 45).
Għal punti ta ’ tmiem komposti, l- effikaċja b’ sinjifikat statistiku kontra l- marda ntweriet kontra tipi ta ’ HPV relatati filoġenetikament għal HPV 16 (primarjament HPV 31) billi ebda effikaċja li hija statistikament sinjifikanti ma ġiet osservata għal tipi ta ’ HPV filoġenetikament relatati ma ’ HPV
Results for CIN 2/ 3 or AIS in Type-Specific HPV-Naïve Subjects† (end of study results) Naïve to ≥ 1 HPV Type
Riżultati għal CIN 2/ 3 jew AIS f’ Suġġetti naïve għall- HPV Speċifiku għat- Tip † (riżultati ta ’ tmiem l - istudju) Naïve għal ≥ Tip ta ’ HPV 1
Silgard
Każijiet ta ’
Composite Endpoint ‡
Punt ta ’ tmiem kompost
cases
Silgard
(HPV 31/ 33/ 45/ 52/ 58) §
43. 2%
4.6, 42.5
25. 8% 23. 0%
5.1, 37.7
4. 6, 42. 5 5. 1, 37. 7
26.2, 74.1† < 0, 52.1† < 0, 61.9† < 0, 44.2† < 0, 61.0†
< 0, 61. 0 †
A5 species (HPV 51)
Speċi A5 (HPV 51)
The studies were not powered to assess efficacy against disease caused by individual HPV types. ‡ Efficacy was based on reductions in HPV 31-related CIN 2/ 3 or AIS
L- istudji ma kinux mgħammra biex jivvalutaw l- effikaċja kontra marda kkawżata minn tipi ta ’ HPV individwali. ‡ L- effikaċja kienet ibbażata fuq tnaqqis f’ CIN 2/ 3 jew AIS relatati ma ’ HPV 31 § 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 59.
Composite Endpoint §
Immunoġeniċità
The immunogenicity of Silgard was assessed in 8,915 (Silgard n = 4,666; placebo n = 4,249) women 18 to 26 years of age and 3,400 female (Silgard n = 1,471; placebo n = 583) and male (Silgard n = 1,071; placebo n = 275) adolescents 9 to 17 years of age.
L- immunoġeniċità ta ’ Silgard kienet evalwata fi 8, 915- il mara (Silgard n = 4, 666; plaċebo n = 4, 249) ta ’ età bejn 18 u 26 sena u fi 3, 400 mara (Silgard n = 1, 471; plaċebo n = 583) u raġel (Silgard n = 1, 071; plaċebo n = 275) adolexxenti ta ’ età bejn 9 u 17- il sena.
Immune Responses to Silgard
Risponsi Immuni għal Silgard
In the clinical studies, 99.9%, 99.8%, 99.8%, and 99.6% of individuals who received Silgard became anti-HPV 6, anti-HPV 11, anti-HPV 16, and anti-HPV 18-seropositive respectively, by 1 month Postdose 3 across all age groups tested.
Fl- istudji kliniċi, 99. 9%, 99. 8%, 99. 8%, u 99. 6% ta ’ l- individwi li rċivew Silgard saru seropożittivi għal anti- HPV 6, anti- HPV 11, anti- HPV 16, u anti- HPV 18, rispettivament, sa żmien xahar Wara d - Doża 3 fost il- gruppi ta ’ etajiet kollha li kienu ttestjati.
Silgard induced high anti-HPV Geometric Mean Titres (GMTs) 1 month Postdose 3 in all age groups tested.
Silgard wassal għal Titres Medji Ġeometriċi (Geometric Mean Titres - GMTs) għoljin ta ’ kontra l- HPV xahar Wara d- Doża 3 fil- gruppi ta ’ etajiet kollha li kienu ttestjati.
Furthermore, anti-HPV levels (GMTs) in vaccinated subjects remained at or above serostatus cut-off during the long-term follow-up of the phase III studies (see below under Persistence).
Aktar minn hekk, il- livelli ta ’ l- anti- HPV (GMTs) fis- suġġetti vaċċinati baqgħu fil- livell tal- qtugħ il- linja ta ’ serostatus
Bridging the Efficacy of Silgard from Young Adult Women to Young Adolescents
Ħolqien ta ’ Pont fl- Effikaċja ta ’ Silgard minn Nisa Żgħażagħ Adulti sa Adolexxenti Żgħar
A clinical study (Protocol 016) compared the immunogenicity of Silgard in 10- to 15-year-old boys and girls to those in 16- to 23-year old adolescent and young women.
Studju kliniku (Protokoll 016) qabbel l- immunoġeniċità ta ’ Silgard f’ subien u bniet li kellhom minn 10 sa 15- il sena ma ’ dik f’ nisa adolexxenti u żgħażagħ ta ’ età bejn 16 u 23 sena.
10 On the basis of this immunogenicity bridging, the efficacy of Silgard in 9- to 15-year-old girls is inferred.
Fuq bażi ta ’ l- ħolqien ta ’ pont ta ’ l- immunoġeniċità, l- effikaċja ta 'Silgard fi bniet ta ’ bejn 9 u 15- il sena hija inferita.
Immunogenicity and safety of Silgard have been demonstrated in 9- to 15-year-old boys.
L- immunoġeniċità u s- sigurtà ta ’ Silgard intweriet f’ subien ta ’ bejn 9 u 15- il sena.
In Protocol 007 peak anti-HPV 6, 11, 16, 18 GMTs were observed at Month 7.
Fi studji ta ’ fażi III, fi tmiem l- istudju, 90%, 95%, 98% u 60% tas- suġġetti li rċievew Gardasil fil - popolazzjoni ta ’ immunoġeniċità skont il- protokoll kienu seropożittivi għal anti- HPV 6, anti- HPV 11, anti- HPV 16 u anti HPV 18, rispettivament.
The GMTs declined through Month 24 and then stabilized until at least Month 60.
Suġġetti li kienu seronegattivi għal anti- HPV 6, 11, 16, 18 fil- cLIA fi tmiem l- istudju kienu għadhom protetti kontra mard kliniku.
The exact duration of immunity following a 3-dose series has not been established.
Evidenza ta ’ Reazzjoni Anamnestika (Memorja Immuni)
In phase III studies, at end of study 90%, 95%, 98% and 60% of subjects who received Silgard in the per-protocol immunogenicity population were anti-HPV 6, anti-HPV 11, anti-HPV 16 and anti HPV 18 seropositive, respectively.
Evidenza ta ’ reazzjoni anamnestika kienet osservata f’ individwi vaċċinati li kienu seropożittivi għat - tip( i) ta ’ HPV rilevanti qabel it- tilqima.
Subjects who were seronegative for anti-HPV 6, 11, 16, 18 in the cLIA at end of study were still protected against clinical disease.
Flimkien ma 'dan, sotto- sett ta ’ individwi vaċċinati li rċivew doża ta ’ sfida ta ’ Silgard 5 snin wara l- bidu tal- tilqima, urew reazzjoni anamnestika mgħaġġla u b’ saħħitha li qabżet l- anti- HPV GMTs osservati xahar Wara d- Doża 3.
Evidence of Anamnestic (Immune Memory) Response
5. 2 Tagħrif farmakokinetiku
5.3 Preclinical safety data
11 5. 3 Tagħrif ta ’ qabel l- użu kliniku dwar is- sigurtà tal- mediċina
Single-dose and repeated-dose toxicity and local tolerance studies revealed no special hazards to humans.
Studji fuq it- tossiċità wara doża waħda u wara doża ripetuta u fuq it- tolleranzi lokali ma żvelaw l- ebda riskji speċjali għall- bnedmin.
Silgard induced specific antibody responses against HPV types 6, 11, 16, and 18 in pregnant rats, following one or multiple intramuscular injections.
Silgard ikkawża risponsi speċifiċi ta ’ l- anti- korpi kontra t- tipi HPV 6, 11, 16, u 18 f’ firien tqal, wara injezzjoni waħda jew aktar fil- muskoli.
11 6.3 Shelf life
6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
Parenteral drug products should be inspected visually for particulate matter and discolouration prior to administration.
12 Prodotti mediċinali parenterali għandhom ikunu eżaminati viżwalment għal materjal f’ sura ta ’ partikuli jew tibdil fil- kulur qabel ma jingħataw.
Single-dose Vial Use Withdraw the 0.5 ml dose of vaccine from the single-dose vial using a sterile needle and syringe free of preservatives, antiseptics, and detergents.
Kif Tuża l- Kunjett għal Doża Waħda Iġbed doża ta ’ 0. 5 ml tal- vaċċin mill- kunjett għal doża waħda permezz ta ’ labra sterilizzata u siringa li tkun ħielsa minn preservattivi, antisettiċi u deterġenti.
Any unused product or waste material should be disposed of in accordance with local requirements.
Rimi Kull prodott mhux użat jew materjal għar- rimi għandu jintrema skond il- liġijiet lokali.
Merck Sharp & Dohme Ltd, Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom
Merck Sharp & Dohme Ltd Hertford Road, Hoddesdon Hertfordshire EN11 9BU Renju Unit
Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed).
Silgard, sospensjoni għall- injezzjoni f’ siringa mimlija lesta Vaċċin għall- Papillomavirus Uman [Tipi 6, 11, 16, 18] (Rikombinanti, adsorbit).
14 insufficient data on immunogenicity, safety and efficacy (see section 5.1).
1q mhux rakkomandat għall- użu fit- tfal taħt il- 9 sena għax m’ hemmx biżżejjed informazzjoni dwar l - immunoġeniċità, is- sigurtà u l- effikaċja (ara sezzjoni 5. 1).
The vaccine should be administered by intramuscular injection.
14 Il- vaċċin għandu jingħata permezz ta ’ injezzjoni ġol- muskoli.
15 There are no safety, immunogenicity or efficacy data to support interchangeability of Silgard with other HPV vaccines.
15 Ma hemm ebda tagħrif dwar is- sigurtà, l- immunoġeniċità jew l- effikaċja li jappoġġja l- interkambjalità ta ’ Silgard ma ’ tilqim HPV ieħor.