qanastek/EMEA-V3 huggingface dataset:
In phase III studies, at end of study 90%, 95%, 98% and 60% of subjects who received Gardasil in the per-protocol immunogenicity population were anti-HPV 6, anti-HPV 11, anti-HPV 16 and anti HPV 18 seropositive, respectively.
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.
Subjects who were seronegative for anti-HPV 6, 11, 16, 18 in the cLIA at end of study were still protected against clinical disease.
Suġġetti li kienu seronegattivi għal anti- HPV 6, 11, 16, 18 fil- cLIA fi tmiem l- istudju kienu għadhom protetti kontra mard kliniku.
Evidence of Anamnestic (Immune Memory) Response
Evidenza ta ’ Reazzjoni Anamnestika (Memorja Immuni)
Evidence of an anamnestic response was seen in vaccinated individuals who were seropositive to relevant HPV type(s) prior to vaccination.
Evidenza ta ’ reazzjoni anamnestika kienet osservata f’ individwi vaċċinati li kienu seropożittivi għat - tip( i) ta ’ HPV rilevanti qabel it- tilqima.
In addition, a subset of vaccinated individuals who received a challenge dose of Gardasil 5 years after the onset of vaccination, exhibited a rapid and strong anamnestic response that exceeded the anti-HPV GMTs observed 1 month Postdose 3.
Flimkien ma 'dan, sotto- sett ta ’ individwi vaċċinati li rċivew 11 doża ta ’ sfida ta ’ Gardasil 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.
Evaluation of pharmacokinetic studies is not required for vaccines.
L- evalwazzjoni ta ’ studji farmakokinetiċi mhix meħtieġa għall- vaċċini.
11 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.
Gardasil induced specific antibody responses against HPV types 6, 11, 16, and 18 in pregnant rats, following one or multiple intramuscular injections.
Gardasil 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.
Antibodies against all four HPV types were transferred to the offspring during gestation and possibly during lactation.
Anti- korpi kontra l- erba ’ tipi kollha ta ’ HPV kienu trasferiti lill- frieħ matul it- tqala u possibbilment waqt it- treddigħ.
There were no treatment- related effects on developmental signs, behaviour, reproductive performance, or fertility of the offspring.
Ma kien hemm l- ebda effetti marbuta mal - kura fuq sinjali ta ’ l- iżvilupp, imġiba, prestazzjoni riproduttiva, jew il- fertilità tal- frieħ.
Sodium chloride L-histidine Polysorbate 80 Sodium borate Water for injections
Sodium chloride L- histidine Polysorbate 80 Sodium borate Ilma għall- injezzjoni.
For adjuvant, see section 2.
Għal sustanzi mhux attivi, ara sezzjoni 2.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Fl- assenza ta ’ studji dwar il- kompatibilità, dan il- prodott mediċinali m’ għandux jitħallat ma ’ prodotti mediċinali oħrajn.
Store in a refrigerator (2°C - 8°C).
Aħżen fil- friġġ (2°C - 8°C).
Keep the vial in the outer carton in order to protect from light.
Żomm il- kunjett fil- kartuna ta ’ barra biex tipproteġih mid- dawl.
0.5 ml suspension in a vial (Type 1 glass) with stopper (FluroTec-coated or Teflon-coated chlorobutyl elastomer) and flip-off plastic cap (aluminium crimp band) in a pack size of 1, 10 or 20.
0. 5 ml sospensjoni f' kunjett (ħġieġ ta 'Tip 1) b’ tapp (miksi bil- FluroTec jew Teflon miksi bil - chlorobutyl elastomer) u għatu tal- plastik flip- off (strixxa crimp ta' l- aluminju) f' pakkett ta '1, 10 jew 20.
Not all pack sizes are marketed.
Mhux il- pakketti tad- daqsijiet kollha jinsabu għall- bejgħ.
The vaccine should be used as supplied; no dilution or reconstitution is necessary.
Il- vaċċin għandu jintuża kif fornut; l- ebda dilwizzjoni jew rikostitużzjoni mhi meħtieġa.
The full recommended dose of the vaccine should be used.
Id- doża sħiħa rakkomandata tal- vaċċin għandha tintuża.
Shake well before use.
12 Ħawwad sewwa qabel l- użu.
Thorough agitation immediately before administration is necessary to maintain suspension of the vaccine.
Hemm bżonn li tħawwad il- prodott sew qabel ma tużah biex iżżomm is - sospensjoni tal- vaċċin.
Parenteral drug products should be inspected visually for particulate matter and discolouration prior to administration.
Prodotti mediċinali parenterali għandhom ikunu eżaminati viżwalment għal materjal f’ sura ta ’ partikuli jew tibdil fil- kulur qabel ma jingħataw.
Discard the product if particulates are present or if it appears discoloured.
Armi l- prodott jekk ikun hemm xi partikuli jew jekk jidher li bidel il- kulur.
Single-dose Vial Use 12 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.
Once the single-dose vial has been penetrated, the withdrawn vaccine should be used promptly, and the vial must be discarded.
Ġaladarba l- kunjett għal doża waħda jkun ittaqqab, il- vaċċin miġbud għandu jintuża immedjatament, u l- kunjett għandu jintrema.
Any unused product or waste material should be disposed of in accordance with local requirements.
Kull prodott mhux użat jew materjal għar- rimi għandu jintrema skond il- liġijiet lokali.
MARKETING AUTHORISATION HOLDER
ID- DETENTUR TA 'L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
20th September 2006
20 ta ’ Settembru 2006
Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed).
Gardasil, sospensjoni għall- injezzjoni f’ siringa mimlija lesta Vaċċin għall- Papillomavirus Uman [Tipi 6, 11, 16, 18] (Rikombinanti, adsorbit).
20 micrograms 40 micrograms 40 micrograms 20 micrograms.
L1 proteina fis- sura ta 'partikuli qishom virus prodotti
L1 protein in the form of virus-like particles produced in yeast cells (Saccharomyces cerevisiae CANADE 3C-5 (Strain 1895)) by recombinant DNA technology.
CANADE 3C- 5 (Speċi 1895)) minn teknoloġija DNA rikombinanti.
Suspension for injection in a pre-filled syringe.
Sospensjoni għall- injezzjoni f’ siringa mimlija lesta
Gardasil 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).
Gardasil 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).
4.2 Posology and method of administration
4. 2 Pożologija u metodu ta ’ l- ghoti
The need for a booster dose has not been established.
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).
14 Paediatric population:
14 Il- vaċċin għandu jingħata permezz ta ’ injezzjoni ġol- muskoli.
Gardasil is not recommended for use in children below 9 years of age due to insufficient data on immunogenicity, safety and efficacy (see section 5.1).
Is- sit preferit huwa ż- żona tad- deltojd fin- naħa ta ’ fuq tad- driegħ jew fiż- żona anterolaterali ogħla tal- koxxa.
The preferred site is the deltoid area of the upper arm or in the higher anterolateral area of the thigh.
Gardasil m’ għandux jiġi injettat intravaskularment.
Therefore, vaccinees should be carefully observed for approximately 15 minutes after administration of Gardasil.
Għalhekk, il- persuni vaċċinati għandhom jiġu osservati għal madwar 15- il minuta wara l- għoti ta ’ Gardasil.
The duration of protection is currently unknown.
It- tul tal- protezzjoni għadu mhux magħruf fil- preżent.
Sustained protective efficacy has been observed for 15 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.
There are no safety, immunogenicity or efficacy data to support interchangeability of Gardasil with other HPV vaccines.
15 Ma hemm ebda tagħrif dwar is- sigurtà, l- immunoġeniċità jew l- effikaċja li jappoġġja l- interkambjalità ta ’ Gardasil ma ’ tilqim HPV ieħor.
16 In 5 clinical trials (4 placebo-controlled), subjects were administered Gardasil 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 Gardasil 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 Gardasil and 4,064 subjects who received placebo.
Is- sigurtà kienet evalwata jew fil- popolazzjoni studjata kollha (4 studji) jew f’ sett 16 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 ’ Gardasil 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 Gardasil u 4, 064 pazjent li rċevew il- plaċebo.
Gastrointestinal disorders: nausea, vomiting.
Disturbi gastrointestinali: tqalligħ, rimettar.
17 General disorders and administration site conditions: asthenia, fatigue, malaise.
17 Disturbi ġenerali u kondizzjonijiet ta 'mnejn jingħata: astenja, għeja, telqa
The efficacy for all other endpoints is based on protocols 007, 013, and 015.
L- effikaċja għall- punti ta ’ tmiem l- oħrajn kollha hija bbażata fuq il- protokolli 007, 013, u 015.
The median duration of follow-up for the combined protocols (005, 007, 013, and 015) was 3.6 years.
It- tul medjan tal- follow- up għall- protokolli flimkien (005, 007, 013, u 015) kien 3. 6 snin.
At end of study, subjects enrolled in the two Phase-III studies (Protocol-013 and Protocol-015), were followed for up to 4 years (median 3.7 years).
Fl- aħħar tal- istudju, is - 18 suġġetti rreġistrati fiż- żewġ studji ta ’ Fażi III (Protokoll 013 u Protokoll 15) ġew segwiti għal perjodu sa 4 snin (medjan 3. 7 snin).
18 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.
The efficacy results for relevant endpoints analysed at 2 years post-enrolment and at end of study (median duration of follow-up = 3.6 years) in the per-protocol population are presented in the Table 1.
Ir- riżultati ta ’ l- effikaċja għall- punti ta ’ tmiem relevanti analizzati fit- 2 u fit- 3 sena wara r - reġistrazzjoni u fl- aħħar tal- istudju (tul medjan tal- follow- up = 3. 6 snin) huma ppreżentati f’ Tabella 1.
Analysis of efficacy of Gardasil against high grade cervical lesions in the PPE population
Analiżi ta 'l- effikaċja ta' Gardasil kontra leżjonijiet ċervikali ta ’ grad għoli fil- popolazzjoni PPE
Placebo Gardasil
Plaċebo Gardasil
Number Number
Numru Numru
Number Number
Effikaċja fl- aħħar tal -
(92.9, 100.0)
100. 0)
100 (86.5, 100.0)
100. 0)
(14.8, 100.0)
100. 0)
*Number of subjects with at least one follow-up visit after Month 7 **Based on virologic evidence, this CIN 3 case in a patient chronically infected with HPV 52 is likely to be causally related to HPV 52.
* Numru ta ’ suġġetti b’ għallinqas żjara ta ’ follow- up waħda wara Xahar 7 ** Abbażi ta ’ evidenza viroloġika, dan il- każ ta ’ CIN 3 f’ pazjent infettat kronikament b’ HPV 52 x’ aktarx li huwa każwalment relatat ma ’ HPV 52.
In the second CIN 3 case observed in a patient infected with HPV 51 at Day 1 (in 2 of 9 specimens); HPV 16 was detected at a Month 51 biopsy (in 1 of 9 specimens) and HPV 56 was detected in 3 of 9 specimens at Month 52 in tissue excised during LEEP. ***Patients were followed for up to 4 years (median 3.6 years) Note:
Fit- tieni każ ta ’ CIN 3 osservat f’ pazjent infettat b’ HPV 51 f’ Jum 1 (fi 2 minn 9 kampjuni); HPV 16 ġie rilevat f’ bijopsija wara Xahar 51 (f’ 1 minn 9 kampjuniu HPV 56 ġie rilevat fi 3 minn 9 kampjuni wara Xahar 52 f’ tessut imneħħi waqt LEEP. *** Il- pazjenti ġew segwiti sa perjodu ta ’ 4 snin (medjan 3. 6 snin) Nota:
At end of study and in the combined protocols,
Fl- aħħar tal- istudju u fil- protokolli kombinati,
the efficacy of Gardasil against HPV 6-, 11-, 16-, 18-related CIN 1 was 95.9% (95% CI:
l- effikaċja ta ’ Gardasil kontra CIN 1 relatata ma ’ HPV 6 -, 11 -, 16 -, 18 kienet ta ’ 95. 9% (95% CI:
91.4, 98.4) the efficacy of Gardasil against HPV 6-, 11-, 16-, 18-related CIN (1, 2, 3) or AIS was 96.0% (95% CI:
19 l; - effikaċja ta ’ Gardasil kontra CIN (1, 2, 3) jew AIS relatata ma ’ HPV 6 -, 11 -, 16 -, 18 - kienet 96. 0% (95% CI:
92.3, 98.2)
92. 3, 98. 2) fil- protokolli kkombinati wara 3 snin.
55.4, 100) respectively
55. 4, 100) rispettivament fil- protokolli kkombinati wara 3 snin
19 the efficacy of Gardasil against HPV 6-, 11-, 16-, 18-related genital warts was 99.0% (95% CI:
l- effikaċja ta ’ Gardasil kontra felul ġenetali relatat ma ’ HPV 6 -, 11 -, 16 -, 18 kienet 99. 0% (95% CI:
96.2,99.9).
96. 2, 99. 9) fil- protokolli kkombinati wara 3 snin.
Placebo
Gardasi Placebo l Numru Numru
Number of Number
ta ’
Number
ta ’
Efficacy**
ta ’
cases
każijiet
of cases
Effikaċja **
Efficacy** of cases
każijiet każijiet
at end of
Numru ta ’
Number of Number
każijiet
at 2 years Num
f’ sena 2
Number of Number at 2 years Number Number
fl- aħħar tal - istudju
subjects*
suġġetti *
of
Numru
(95% CI) of of
Numru Numru
of (95% CI) of of
(95% CI) (95% CI)
(95% CI)
ta ’ ta ’
subjects*
ta ’
subjects* subjects*
suġġetti *
HPV 16- or HPV
suġġetti suġġetti * *
51.8
(41. 1, 60. 7)
18-related CIN 2/ 3 or AIS
relatati ma ’ HPV 16 jew HPV 18
46.0 (31.0, 57.9)
(12. 7, 50. 8)
HPV 16/ 18-
(31. 0, 57. 9)
60.0
(< 0, 87. 6)
related AIS
(< 0, 87. 3)
9904
990
Efficacy against HPV 6-, 11-, 16-, 18-related VIN 2/ 3 was 73.3% (95% CI:
20 L- effikaċja kontra VIN 2/ 3 relatata ma ’ HPV 6 -, 11 -, 16 -, 18 kienet ta ’ 73. 3% (95% CI:
20 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 Gardasil 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 ’ Gardasil 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 Gardasil reduced the incidence of CIN 2/ 3 or AIS caused by vaccine- or non-vaccine HPV types by 42.7% (95% CI:
Fil - popolazzjoni naïve għall- HPV (naïve għal 14- il tip ta ’ HPV komuni u li kellhom test Pap negattiv f’ Jum 1), Gardasil naqqas il- proporzjon ta ’ nisa li esperjenzaw, proċedura ta ’ terapija ċervikali definittiva (Loop Electro- Excision Procedure jew Cold- Knife Conization) b’ 41. 9% (95% CI:
23.7, 57.3) and of genital warts by 82.8% (95% CI:
27. 7, 53. 5) fl- aħħar tal- istudju.
74.3, 88.8)at end of study.
15. 2, 31. 7.
In the HPV naïve population (naïve to 14 common HPV types and had a negative Pap test at Day 1), Gardasil 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 naïve għall- HPV, Gardasil naqqas il- proporzjon ta ’ nisa li esperjenzaw, proċedura ta ’ terapija ċervikali definittiva (Loop Electro- Excision Procedure jew Cold- Knife Conization) b’ 41. 9% (95% CI:
27.7, 53.5) at end of study.
27. 7, 53. 5;) fl- aħħar tal- istudju.
Cross-protective efficacy The efficacy of Gardasil 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 ’ Gardasil 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 medjan ta ’ 3. 7 snin (fl- aħħar ta ’ l- istudju).
Efficacy against disease endpoints caused by pre-specified combinations of non-vaccine HPV types was measured.
L- effikaċja kontra punti ta ’ tmiem tal- marda ikkawżata minn kombinazzjonijiet pre- speċifikati ta ’ tipi HPV tal- vaċċin ġiet imkejla.
The final end-of-study results for the combined incidence of CIN 2/ 3 or AIS in this population after a median follow-up of 3.7 years are shown in Table 3.
Ir- riżultati finali ta ’ l- aħħar ta ’ l- istudju għall- inċidenza kombinata ta ’ CIN 2/ 3 jew AIS f’ din il- popolazzjoni wara follow- up medjan ta ’ 3. 7 snin huma murija fit- Tabella 1.
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 18 (inkluż HPV 45).
Immune Responses to Gardasil
Risponsi Immuni għal Gardasil
In the clinical studies, 99.9%, 99.8%, 99.8%, and 99.6% of individuals who received Gardasil 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 Gardasil 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.
22 Bridging the Efficacy of Gardasil from Young Adult Women to Young Adolescents
22 Ħolqien ta ’ Pont fl- Effikaċja ta ’ Gardasil minn Nisa Żgħażagħ Adulti sa Adolexxenti Żgħar
Subjects who were seronegative for anti-HPV 6, 11, 16, 18 in the cLIA at end of study were still protected against clinical disease.
Suġġetti li kienu seronegattivi għal anti- HPV 6, 11, 16, 18 fil- cLIA fi tmiem l- istudju kienu għadhom protetti kontra mard kliniku
In addition, a subset of vaccinated individuals who received a challenge dose of Gardasil 5 years after the onset of vaccination, exhibited a rapid and strong anamnestic response that exceeded the anti-HPV GMTs observed 1 month Postdose 3.
Flimkien ma 'dan, sotto- sett ta ’ individwi vaċċinati li rċivew doża ta ’ sfida ta ’ Gardasil 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.
23 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.
Gardasil induced specific antibody responses against HPV types 6, 11, 16, and 18 in pregnant rats, following one or multiple intramuscular injections.
23 Gardasil 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.
Keep the pre-filled syringe in the outer carton in order to protect from light.
Żomm is- siringa mimlija lesta fil- kartuna ta ’ barra biex tipproteġiha mid- dawl.
0.5 ml suspension in a pre-filled syringe (Type 1 glass) with plunger stopper (siliconized FluroTec- coated bromobutyl elastomer or non-coated chlorobutyl elastomer) and tip cap (bromobutyl) with needle guard (safety) device, without needle or with one or two needle(s) - pack size of 1, 10 or 20.
Sospensjoni ta '0. 5 ml f' siringa mimlija lesta (ħġieġ ta' Tip 1) b' tapp planġer (siliconized FluroTec - coated bromobutyl elastomer jew non- coated chlorobutyl elastomer) u għatu tat- tarf (bromobutyl) b' apparat tal- protezzjoni tal- labra (sigurtà), mingħajr labra jew b' labra waħda jew tnejn - daqs tal - pakkett ta '1, 10 jew 20.
0.5 ml suspension in a pre-filled syringe (Type 1 glass) with plunger stopper (siliconized FluroTec- coated bromobutyl elastomer or non-coated chlorobutyl elastomer) and tip cap (bromobutyl) without needle guard (safety) device without needle or with one or two needle(s) - pack size of 1, 10 or 20.
Sospensjoni ta '0. 5 ml f' siringa mimlija lesta (ħġieġ ta' Tip 1) b' tapp planġer (siliconized FluroTec - coated bromobutyl elastomer jew non- coated chlorobutyl elastomer) u għatu tat- tarf (bromobutyl) mingħajr apparat tal- protezzjoni tal- labra (sigurtà), mingħajr labra jew b' labra waħda jew tnejn - daqs tal- pakkett ta '1, 10 jew 20.
Gardasil is available in a pre-filled syringe ready to use for intramuscular injection (IM), preferably in the deltoid area of the upper arm.
Gardasil huwa disponibbli f’ siringa mimlija għal- lest biex tintuża għal injezzjoni ġol - muskoli (IM), preferibbilment fiż- żona tad- deltojd tan- naħa ta ’ fuq tad- driegħ.
If 2 needles of different lengths are provided in the pack, choose the appropriate needle to ensure an IM administration depending on your patient’s size and weight.
Jekk fil- pakkett ikun hemm 2 labriet ta ’ tulijiet differenti, agħżel il- labra adattata sabiex tiżgura amministrazzjoni IM skond id- daqs u l- piż tal- pazjent tiegħek.
Using the pre-filled syringe with needle guard (safety) device
Kif għandek tuża s- siringa mimlija b’ apparat ta ’ protezzjoni (sigurtà) tal- labra
The needle guard (safety) device consists of a plastic cylinder (needle guard) that, before the dose is given, covers the syringe barrel.
L- apparat ta ’ protezzjoni (sigurtà) tal- labra huwa magħmul minn ċilindru tal- plastik (protezzjoni tal - labra) li, qabel ma tingħata d- doża, jgħatti l- bettija tas- siringa.
The needle guard covers the needle after injection to prevent needle stick injury.
L- apparat ta ’ protezzjoni tal- labra jgħatti l- labra wara l- injezzjoni sabiex jevita korriment bil- labra.
When the injection is completed and the plunger is fully depressed, the plunger will engage the activation clips.
Malli titlesta l- injezzjoni u l- planġer jiġi magħfus għalkollox, il- planġer jħaddem il- clips ta ’ l- attivazzjoni.
Upon release of the plunger, the plastic cylinder will rapidly move to cover the needle.
Malli jintelaq il- planġer, iċ - ċilindru tal- plastik, b’ għaġla kbira, se jgħatti l- labra.
If no needle is available in the pack, use a needle not exceeding 25 mm in length to allow the needle guard to cover the needle completely.
Jekk ma jkunx hemm labra fil- pakkett, uża labra b’ tul ta ’ mhux iktar minn 25 mm biex tippermetti l- apparat ta ’ protezzjoni (sigurtà) tal- labra li jgħattiha kompletament.
Prior to completion of the injection, avoid contact with the activation clips (as indicated by asterisks * in the first illustration) on the device to keep from prematurely covering the needle with the needle guard.
Qabel ma tkun lesta l- injezzjoni, evita kuntatt mal- klips ta ’ l- attivazzjoni (kif indikat bl - asterisks * fl- ewwel stampa) fuq l- apparat biex tevita li l- labra tiġi mgħottija kmieni wisq bl - apparat ta ’ protezzjoni tal- labra.
Ensure that the air bubbles are removed from the syringe before injection.
Kun żgur li kwalunkwe bżieżaq ta ’ l- arja jitneħħew mis- siringa qabel l- injezzjoni.
The labels can only be removed after vaccine injection and when the needle guard covers the needle.
It- tikketti jistgħu jitneħħew biss wara l- injezzjoni tal- vaċċin u meta l- għant tal- labra tgħatti l- labra.
Shake well before use.
Ħawwad sewwa qabel l- użu.
Remove the syringe tip cap and the needle cap.
Neħħi l- għatu tal- ponta tas- siringa u l- għatu tal- labra.
Screw the needle onto the syringe barrel in a clockwise direction while pressing in the 2 plastic beads to lock the needle securely onto the syringe.
Invita l- labra mal- bettija tas- siringa fid- direzzjoni tal- ħin waqt li tagħfas fuq iż- żewġ żibġiet tal- plastik biex tillokkja l- labra sewwa għal fuq is- siringa.
Remove the needle shield.
Neħħi l- għant tal- labra.
Inject the full dose by slowly pushing the plunger forward until it cannot be pushed further.
Injetta d- doża sħiħa billi tagħfas bil- mod il- planġer ’ il quddiem sakemm ma jkunx jista ’ jiġi imbottat aktar.
Do not release the pressure on the plunger.
Terħix il- pressjoni fuq il- planġer.
While maintaining pressure on the plunger, remove the syringe from the patient.
Filwaqt li żżomm il- pressjoni fuq il- planġer, neħħi s- siringa mill - pazjent.
Release the plunger slowly.
Itlaq il- planġer bil- mod.
The needle guard will rapidly move to cover the needle.
L- apparat ta ’ protezzjoni tal- labra jiċċaqlaq b’ għaġla kbira biex jgħatti l- labra.
25 To remove the detachable labels, rotate the plunger until the coloured tab becomes visible.
25 Biex tneħħi t- tikketti li jinqalgħu, dawwar il- planġer sakemm it- tab bil- kulur jiġi jidher.
Pull on the coloured tab while continuing to rotate the plunger as needed.
Iġbed it- tab tal- kulur filwaqt li tkompli ddawwar il- planġer kif meħtieġ.
Using the pre-filled syringe without needle guard (safety) device
Kif għandek tuża s- siringa mimlija għal- lest mingħajr apparat ta ’ protezzjoni (sigurtà) tal- labra
Attach the needle by twisting in a clockwise direction until the needle fits securely on the syringe.
Waħħal il- labra billi ddawwarha fid- direzzjoni tal- ħin sakemm il- labra teħel sod mas- siringa.
Administer the entire dose as per standard protocol.
Agħti d- doża sħiħa skond il- protokoll standard.
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR( I) TAS- SUSTANZA( I) BIJOLOĠIKA( ĊI) ATTIVA( I) U SID/ SIDIEN TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI MILL- ĦRUĠ TAL- LOTT
Name and address of the manufacturer(s) of the biological active substance(s)
Isem u indirizz tal- manifattur( i) tas- sustanza bijoloġika attiva
Merck & Co., INC Sumneytown Pike P.O.Box 4 West Point PA 19486 USA
Merck & Co., INC Sumneytown Pike P. O. Box 4 West Point PA 19486 Stati Uniti ta ’ l- Amerika
CONDITIONS OF THE MARKETING AUTH ORISATION
KUNDIZZJONIJIET TA 'L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
Not aplicable.
Mhux applikabbli
Pharmacovigilance system
Sistema ta 'farmako- viġilanza
The MAH must ensure that the system of pharmacovigilance, as described in version 1 (dated October 2005) presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Il- MAH irid jiżgura li s- sistema ta 'farmako- viġilanza kif deskritta fil- verżjoni 1 (datata Ottubru 2005) ippreżentata fil- Modulu 1. 8. 1. ta ’ l- Applikazzjoni għall- Awtorizzazzjoni għat- Tqegħid fis- Suq tkun fis- seħħ u li din tkun qed taħdem qabel u waqt li l- prodott ikun fis- suq.
Risk Management plan
Pjan ta 'l- Immaniġġjar tar- Riskju
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 2 (dated August 2007) of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Il- MAH iwiegħed li jwettaq l- istudji u l- attivitajiet ta ’ farmakoviġilanza addizzjonali deskritti fid - dettall fil- Pjan ta ’ Farmakoviġilanza, kif sar qbil fuqu fil- verżjoni 2 (datata Awissu 2007) tal- Pjan tal - Ġestjoni tar- Riskju (RMP) ippreżentat fil- Modulu 1. 8. 2 ta ’ l- Applikazzjoni għall- Awtorizzazzjoni għat- Tqegħid fis- Suq u kwalunkwe aġġornament sussegwenti tal- RMP li jkun sar qbil fuqu mill - CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
28 Fir- rigward tal- Linja Gwida tal- CHMP dwar Sistemi ta ’ Ġestjoni tar- Riskji għal prodotti mediċinali għal użu mill- bniedem, l- RMP aġġornat għandu jiġi ppreżentat fl- istess ħin tar- Rapport Perjodiku ta ’ Aġġornament tas- Sigurtà (PSUR).
In addition, an updated RMP should be submitted:
Barra minn hekk, għandu jiġi ppreżentat RMP aġġornat:
28  When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities  Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached  At the request of the EMEA
• Meta tasal informazzjoni ġdida li jista ’ jkollha impatt fuq l- Ispeċifikazzjoni tas- Sigurtà attwali, il- Pjan ta ’ Farmakoviġilanza jew l- attivitajiet ta ’ minimizzazzjoni tar- riskji • Fi żmien 60 jum minn meta tintlaħaq mira importanti (farmakoviġilanza jew minimizzazzjoni tar- riskji) • Fuq talba ta ’ l- EMEA
Official batch release: in accordance with Article 114 Directive 2001/83/EC as amended, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.
Skond Artikolu 114 tad- Direttiva 2001/ 83/ KE kif emendata, il- ħruġ uffiċjali tal - lott ser ikun ir- responsabbiltà ta 'laboratorju ta' l- Istat jew ta 'laboratorju magħżul għal dak il- għan.
31 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON TEXT Gardasil, suspension for injection – single dose vial, pack of 1, 10, 20
31 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA KLIEM FUQ IL- KARTUNA TA 'BARRA Gardasil, sospensjoni għall- injezzjoni – kunjett għal doża waħda, pakkett ta' 1, 10, 20
1 dose (0.5 ml) contains:
Doża waħda (0. 5 ml) fiha:
HPV Type 6 L1 protein HPV Type 11 L1 protein HPV Type 16 L1 protein HPV Type 18 L1 protein
Proteina HPV Tip 6 L1 Proteina HPV Tip 11 L1 Proteina HPV Tip 16 L1 Proteina HPV Tip 18 L1
Adsorbed on amorphous aluminium hydroxyphosphate sulphate (225 µg Al).
Adsorbit fuq amorphous aluminium hydroxyphosphate sulphate (225 µg Al).
Sodium chloride, L-histidine, polysorbate 80, sodium borate, water for injections.
Sodium chloride, L- histidine, polysorbate 80, sodium borate, ilma għall- injezzjoni.
Suspension for injection.
Kunjett b' doża waħda, 0. 5 ml.
Intramuscular (IM) use.
Biex jingħata ġol- muskoli (IM).
Read the package leaflet before use.
Aqra l- fuljett ta 'tagħrif fil- pakkett qabel l- użu.
EXP MM/YYYY 32 9.
JIS XX/ SSSS
Store in a refrigerator.
Aħżen fil- friġġ.
Sanofi Pasteur MSD SNC 8 rue Jonas Salk F-69007 Lyon France
Sanofi Pasteur MSD SNC 8, rue Jonas Salk F- 69007 Lyon Franza
EU/1/06/357/001 – pack of 1 EU/1/06/357/002– pack of 10 EU/1/06/357/018– pack of 20
EU/ 1/ 06/ 357/ 001 – pakkett ta ’ 1 EU/ 1/ 06/ 357/ 002 – pakkett ta ’ 10 EU/ 1/ 06/ 357/ 018 – pakkett ta ’ 20
MANUFACTURER’S BATCH NUMBER
NUMRU TAL- LOTT TAL- MANIFATTUR
33 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL TEXT
33 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN KLIEM TAT- TIKKETTA TAL- KUNJETT
IM use.
IM use.
EXP MM/YYYY
JIS XX/ SSSS
1 dose, 0.5 ml.
Doża waħda, 0. 5 ml.
34 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON TEXT Gardasil, suspension for injection – pre-filled syr inge without needle, p ack of 1, 10, 20
34 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA KLIEM FUQ IL- KARTUNA TA 'BARRA Gardasil, sospensjoni għall- injezzjoni – siringa mimlija lesta mingħajr labra, pakkett ta' 1, 10, 20
Gardasil, suspension for injection in a pre-filled syringe.
Gardasil, sospensjoni għall- injezzjoni f’ siringa mimlija lesta.
1 dose (0.5 ml) dose contains:
Doża waħda (0. 5 ml) fiha:
Suspension for injection in a pre-filled syringe.
Sospensjoni għall- injezzjoni f’ siringa mimlija lesta.
1 dose, 0.5 ml pre-filled syringe without needle.
Doża waħda, siringa mimlija lesta ta '0. 5 ml mingħajr labra.
10 single doses, 0.5 ml pre-filled syringes without needles.
10 dożi singli, siringi mimlijin lesti ta '0. 5 ml mingħajr labar.
20 single doses, 0.5 ml pre-filled syringes without needles.
20 doża singola, siringi mimlijin lesti ta '0. 5 ml mingħajr labar.
EXP MM/YYYY 35 9.
JIS XX/ SSSS 35 9.
Keep the syringe in the outer carton in order to protect from light.
Żomm is- siringa fil- kartuna ta ’ barra biex tipproteġiha mid- dawl.
Sanofi Pasteur MSD SNC 8, rue Jonas Salk F-69007 Lyon France
Sanofi Pasteur MSD SNC 8, rue Jonas Salk F- 69007 Lyon Franza
EU/1/06/357/003 – pack of 1 EU/1/06/357/004 – pack of 10 EU/1/06/357/019 – pack of 20
EU/ 1/ 06/ 357/ 003 – pakkett ta ’ 1 EU/ 1/ 06/ 357/ 004 – pakkett ta ’ 10 EU/ 1/ 06/ 357/ 019 – pakkett ta ’ 20
36 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON TEXT Gardasil, suspension for injection – pre-filled syr inge with 1 needle, p ack of 1, 10, 20
36 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA KLIEM FUQ IL- KARTUNA TA 'BARRA Gardasil, sospensjoni għall- injezzjoni – siringa mimlija lesta b' labra waħda, pakkett ta' 1, 10, 20
1 dose, 0.5 ml pre-filled syringe with 1 needle.
Doża waħda, siringa mimlija lesta ta '0. 5 ml b' labra waħda.
10 single doses, 0.5 ml pre-filled syringes with 1 needle each.
10 dożi singli, siringi mimlijin lesti ta '0. 5 ml b' labra waħda kull waħda.
20 single doses, 0.5 ml pre-filled syringes with 1 needle each.
20 doża singola, siringi mimlijin lesti ta '0. 5 ml b' labra waħda kull waħda.
EXP MM/YYYY 37 9.
JIS XX/ SSSS
EU/1/06/357/005 – pack of 1 EU/1/06/357/006 – pack of 10 EU/1/06/357/020 – pack of 20
EU/ 1/ 06/ 357/ 005 – pakkett ta '1 EU/ 1/ 06/ 357/ 006 – pakkett ta' 10 EU/ 1/ 06/ 357/ 020 – pakkett ta ’ 20
38 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON TEXT Gardasil, suspension for injection – pre-filled syr inge with 2 needles, p ack of 1, 10, 20
38 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA KLIEM FUQ IL- KARTUNA TA 'BARRA Gardasil, sospensjoni għall- injezzjoni – siringa mimlija lesta b' 2 labriet, pakkett ta' 1, 10, 20
adsorbed on amorphous aluminium hydroxyphosphate sulphate (225 µg Al).
adsorbit fuq amorphous aluminium hydroxyphosphate sulphate (225 µg Al).
1 dose, 0.5 ml pre-filled syringe with 2 needles.
Doża waħda, siringa mimlija lesta ta '0. 5 ml b' 2 labriet.
10 single doses, 0.5 ml pre-filled syringes with 2 needles each.
10 dożi singli, siringi mimlijin lesti ta '0. 5 ml b' 2 labriet kull waħda.
20 single doses, 0.5 ml pre-filled syringes with 2 needles each.
20 doża singola, siringi mimlijin lesti ta '0. 5 ml b' labra waħda kull waħda.
EXP MM/YYYY 39 9.
JIS XX/ SSSS
EU/1/06/357/007– pack of 1 EU/1/06/357/008 – pack of 10 EU/1/06/357/021 – pack of 20
EU/ 1/ 06/ 357/ 007 – pakkett ta '1 EU/ 1/ 06/ 357/ 008 – pakkett ta' 10 EU/ 1/ 06/ 357/ 021 – pakkett ta ’ 20
40 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON TEXT Gardasil, suspension for injection – pre-filled syr inge with a needle guard and no needles, pack of 1, 10, 20
40 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA KLIEM FUQ IL- KARTUNA TA 'BARRA Gardasil, sospensjoni għall- injezzjoni – siringa mimlija lesta bi protezzjoni tal- labra u bla labar, pakkett ta' 1, 10, 20
1 dose, 0.5 ml pre-filled syringe with a needle guard and no needles.
Doża waħda, siringa mimlija lesta ta '0. 5 ml bi protezzjoni tal- labra u mingħajr labar.
10 single doses, 0.5 ml pre-filled syringes with needle guards and no needles.
10 dożi singli, siringi mimlijin lesti ta '0. 5 ml bi protezzjoni tal- labra u u mingħajr labar.
20 single doses, 0.5 ml pre-filled syringes with needle guards and no needles.
20 dożi singli, siringi mimlijin lesti ta '0. 5 ml bi protezzjoni tal- labra u u mingħajr labar.
41 EXP MM/YYYY
JIS XX/ SSSS 41 9.
EU/1/06/357/009– pack of 1 EU/1/06/357/010 – pack of 10 EU/1/06/357/011 – pack of 20
EU/ 1/ 06/ 357/ 009 – pakkett ta '1 EU/ 1/ 06/ 357/ 010 – pakkett ta' 10 EU/ 1/ 06/ 357/ 011 – pakkett ta '20
42 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON TEXT Gardasil, suspension for injection – pre-filled syr inge with a needle guard and 1 needle, pack of 1, 10, 20
42 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA KLIEM FUQ IL- KARTUNA TA 'BARRA Gardasil, sospensjoni għall- injezzjoni – siringa mimlija lesta bi protezzjoni tal- labra u labra waħda, pakkett ta' 1, 10, 20
1 dose, 0.5 ml pre-filled syringe with a needle guard and 1 needle.
Doża waħda, siringa mimlija lesta ta '0. 5 ml bi protezzjoni tal- labra u b' labra waħda.
10 single doses, 0.5 ml pre-filled syringes with needle guards and 1 needle each.
10 dożi singli, siringi mimlijin lesti ta '0. 5 ml bi protezzjoni tal- labra u b' labra waħda kull waħda.
20 single doses, 0.5 ml pre-filled syringes with needle guards and 1 needle each.
20 dożi singli, siringi mimlijin lesti ta '0. 5 ml bi protezzjoni tal- labra u b' labra waħda kull waħda.
43 EXP MM/YYYY
JIS XX/ SSSS 43 9.
EU/1/06/357/012– pack of 1 EU/1/06/357/013 – pack of 10 EU/1/06/357/014 – pack of 20
EU/ 1/ 06/ 357/ 012 – pakkett ta '1 EU/ 1/ 06/ 357/ 013 – pakkett ta' 10 EU/ 1/ 06/ 357/ 014 – pakkett ta '20
44 PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON TEXT Gardasil, suspension for injection – pre-filled syr inge with a needle guard and 2 needles, pack of 1, 10, 20
44 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA KLIEM FUQ IL- KARTUNA TA 'BARRA Gardasil, sospensjoni għall- injezzjoni – siringa mimlija lesta bi protezzjoni tal- labra u b' 2 labriet, pakkett ta' 1, 10, 20
Adsorbed on amorphous aluminium hydroxyphosphate sulphate (225 µg Al).
adsorbit fuq amorphous aluminium hydroxyphosphate sulphate (225 µg Al).
1 dose, 0.5 ml pre-filled syringe with a needle guard and 2 needles.
Sospensjoni għall- injezzjoni f’ siringa mimlija lesta Doża waħda, siringa mimlija lesta ta '0. 5 ml bi protezzjoni tal- labra u b' 2 labriet.
10 single doses, 0.5 ml pre-filled syringes with needle guards and 2 needles each.
10 dożi singli, siringi mimlijin lesti ta '0. 5 ml bi protezzjoni tal- labra u b' 2 labriet kull waħda.
20 single doses, 0.5 ml pre-filled syringes with needle guards and 2 needles each.
20 dożi singli, siringi mimlijin lesti ta '0. 5 ml bi protezzjoni tal- labra u b' 2 labriet kull waħda.
45 EXP MM/YYYY
JIS XX/ SSSS 45 9.
EU/1/06/357/015– pack of 1 EU/1/06/357/016 – pack of 10 EU/1/06/357/017 – pack of 20
EU/ 1/ 06/ 357/ 015 – pakkett ta '1 EU/ 1/ 06/ 357/ 016 – pakkett ta' 10 EU/ 1/ 06/ 357/ 017 – pakkett ta '20
46 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Pre-filled syringe label text
46 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN Kliem fuq it- tikkett tas- siringa mimlija lesta
PACKAGE LEAFLET (VIAL)
FULJETT TA 'TAGĦRIF (KUNJETT)
48 PACKAGE LEAFLET:
48 FULJETT TA ’ TAGĦRIF:
Gardasil, suspension for injection Human Papillomavirus Vaccine [Types 6, 11, 16, 18] (Recombinant, adsorbed)
Vaċċin għall- Papillomavirus Uman [Tipi 6, 11, 16, 18] (Rikombinanti, adsorbit)
Read all of this leaflet carefully before you or your child are vaccinated.
Aqra dan il- fuljett kollu bl- attenzjoni qabel int jew it- tifel/ tifla tiegħek tkunu mlaqqma.
- This vaccine has been prescribed for you or your child.
- Dan il- vaċċin ingħata lilek jew lit- tifel/ tifla tiegħek.
Do not pass it on to others.
TAGĦTIHX lil persuni oħra.
please tell your doctor or pharmacist.
imniżżlin f' dan il- fuljett, jekk jogħġbok għid it- tabib jew lill- ispiżjar tiegħek.
What Gardasil is and what it is used for 2.
X’ inhu Gardasil u għalxiex jintuża 2.
Before you use Gardasil 3.
Qabel ma tuża Gardasil 3.
How to use Gardasil 4.
Kif għandek tuża Gardasil 4.
How to store Gardasil 6.
Kif taħżen Gardasil 6.
WHAT GARDASIL IS AND WHAT IT IS USED FOR
X’ INHU GARDASIL U GĦALXIEX JINTUŻA
Gardasil is a vaccine.
Gardasil hu vaċċin.
Vaccination with Gardasil is intended to protect against diseases caused by Human Papillomavirus (HPV) types 6, 11, 16, and 18.
It- tilqima b’ Gardasil hi maħsuba biex tipproteġi kontra l- mard ikkawżat mill - Papillomavirus Uman (HPV) tat- tipi 6, 11, 16 u 18.
These diseases include cervical cancer; pre-cancerous lesions of the female genitals (cervix, vulva and vagina); and genital warts.
Dan il- mard jinkludi l- kanċer ċervikali, feriti pre- kanċeroġeni tal- partijiet ġenitali femminili (cervix, vulva u vaġina); u l- felul ġenitali.
HPV types 16 and 18 are responsible for ~70% of cervical cancer cases and 70% of HPV-related pre-cancerous lesions of the vulva and vagina.
It- tipi HPV 16 u 18 huma responsabbli għal ~70% ta ’ leżjonijiet pre- kanċerużi relatati ma ’ HPV.
HPV types 6 and 11 are responsible for approximately 90% of genital wart cases.
It- tipi HPV 6 u 11 huma responsabbli għal madwar 90% tal- każijiet ta ’ felul ġenitali.
Gardasil cannot cause the diseases it protects against.
Gardasil ma jistax jikkawża l- mard li jagħti protezzjoni kontrihom.
Gardasil produces type-specific antibodies and has been shown in clinical trials to prevent these HPV 6-, 11-, 16-, and 18-related diseases in adult women 16-26 years of age.
Gardasil jipproduċi anti- korpi speċifiċi għat- tip u fil- provi kliniċi ntwera li jippreveni dan il- mard marbut ma ’ HPV 6, 11, 16, u 18 f’ nisa adulti ta ’ età ta ’ bejn 16 u 26 sena.
The vaccine also produces antibodies in 9- to 15-year-old children and adolescents.
Il- vaċċin jipproduċi wkoll anti- korpi fit- tfal u fl- adolexxenti ta ’ bejn 9 u 15- il sena.
Whether these type-specific antibodies prevent disease in adult males has not been evaluated.
Ma kienx evalwat jekk dawn l- anti- korpi speċifiċi għat- tip jipprevenux il- mard f’ irġiel adulti.
Gardasil should be used in accordance with official guidelines.
Gardasil għandu jintuża skond il- linji gwida uffiċjali.
The most benefit from Gardasil is expected before infection with any of the Human Papillomavirus types covered by the vaccine.
L- ikbar benefiċċju minn Gardasil hu mistenni qabel l- infezzjoni b’ xi wieħed mit- tipi ta ’ Papillomavirus Umani koperti mill- vaċċin.
However, in individuals who are already infected by one or more of the vaccine HPV types, the vaccine will protect against the remaining vaccine related HPV types.
Madankollu, f’ individwi li huma diġà infettati b’ wieħed jew iktar mill- vaċċini tat- tipi HPV, il- vaċċin se jipproteġi kontra l- bqija tat- tipi ta ’ HPV marbuta mal - vaċċin.
BEFORE YOU USE GARDASIL
QABEL MA TUŻA GARDASIL
Do not use Gardasil if:
Tużax Gardasil jekk:
 is allergic (hypersensitive) to any of the active substances or any of the other ingredients of Gardasil (listed under “other ingredients”– see section 6).  has developed an allergic reaction after receiving a dose of Gardasil.
il- persuna li ser titlaqqam • hi allerġika (għandha sensittività eċċessiva) għal xi waħda mis- sustanza attivi li jinsabu f’ Gardasil (elenkati taħt “ sustanzi oħra ” – ara sezzjoni 6). • żviluppat reazzjoni allerġika wara li rċeviet doża ta ’ Gardasil.
49  suffers from an illness with high fever.
49 • issofri minn mard b’ deni qawwi.
However, a mild fever or upper respiratory infection (for example cold) itself is not a reason to delay vaccination.
Madankollu, deni ħafif jew infezzjoni fl- apparat respiratorju ta ’ fuq (pereżempju riħ) mhumiex fihom infushom raġuni biex tkun it- tilqima tingħata aktar tard.
Take special care with Gardasil:
Oqgħod attent ħafna b’ Gardasil:
 has a bleeding disorder (a disease that makes you bleed more than normal), for example haemophilia  has a weakened immune system, for example due to a genetic defect or HIV infection
Għandek tgħid lit- tabib tiegħek jekk il- persuna li ser titlaqqam: • għandha mard ta 'ħruġ ta' demm (marda li ġġiegħelek titlef aktar demm mis- soltu), pereżempju l- emofilja • għandha sistema immuni batuta, pereżempju minħabba difett ġenetiku jew infezzjoni bl- HIV.
As with any vaccine, Gardasil may not fully protect 100% of those who get the vaccine.
Bħal kull vaċċin, Gardasil jista ’ ma jipproteġix kompletament 100% lil dawk li jingħataw il- vaċċin.
Gardasil will not protect against every type of Human Papillomavirus.
Gardasil mhux ser jipproteġi kontra kull tip ta ’ Papillomavirus Uman.
Therefore appropriate precautions against sexually transmitted disease should continue to be used.
Għaldaqstant, għandhom jibqgħu jintużaw prekawzjonijiet xierqa kontra mard trasmess sesswalment.
Gardasil will not protect against other diseases that are not caused by Human Papillomavirus.
Gardasil mhux ser jipproteġi kontra mard ieħor li mhux ikkawżat mill- Papillomavirus Uman.
You should continue to follow your doctor’s advice on cervical smear/Pap tests and preventative and protective measures.
Inti għandek tkompli ssegwi l- parir tat- tabib tiegħek dwar is- smear ċervikali/ testijiet Pap u l- miżuri preventivi u protettivi.
What other important information should I know about Gardasil?
X’ informazzjoni importanti oħra għandi nkun naf dwar Gardasil?
Longer term follow-up studies are ongoing to determine whether a booster dose is needed.
Studji ta ’ follow- up li saru fuq perjodu iktar fit- tul u li għadhom għaddejjin, ser jiddeterminaw jekk hemmx bżonn ta ’ doża booster.
Taking other medicines:
L- użu ta ’ mediċini oħra:
Gardasil can be given with Hepatitis B vaccine at a separate injection site (another part of your body, e.g. the other arm or leg) at the same visit.
Gardasil jista ’ jingħata mal- vaċċin ta ’ l- Epatite B f’ sit differenti ta ’ l- injezzjoni (parti oħra minn ġismek, eż. id- driegħ l- ieħor jew ir- riġel l- ieħor) waqt l- istess żjara.
 used with medicines that suppress the immune system.
Gardasil jista ’ ma jkollux l- aħjar effett jekk: • jintuża ma ’ mediċini li jrażżnu s- sistema immuni.
In clinical trials, oral or other contraceptives (e.g. the pill) did not reduce the protection obtained by Gardasil.
Fi provi kliniċi, kontraċettivi orali jew kontraċettivi oħrajn (eż. pilloli) ma naqqsux il- protezzjoni miksuba minn Gardasil.
Please tell your doctor or pharmacist if the person for whom the vaccine is intended is taking or has recently taken any other medicines, including medicines obtained without a prescription.
Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk il- persuna li għaliha l- vaċċin hu intenzjonat, qed tieħu, jew dan l- aħħar ħadet xi mediċini oħra, anki dawk mingħajr riċetta.
Pregnancy and breast-feeding:
Tqala u treddigħ:
Consult your doctor if the person to be vaccinated is pregnant, trying to become pregnant or becomes pregnant during the course of vaccination.
Jekk jogħġbok tkellem mat- tabib tiegħek jekk il- persuna li ser titlaqqam hi tqila, qed tipprova tinqabad tqila jew tinqabad tqila matul il- kors tat- tilqima.
Gardasil may be given to women who are breast-feeding or intend to breast-feed.
Gardasil jista ’ jingħata lil nisa li qed ireddgħu jew li beħsiebhom ireddgħu.
Driving and using machines:
Sewqan u l- użu tal- magni:
There is no information to suggest that Gardasil affects your ability to drive or use machinery.
M’ hemm l- ebda informazzjoni li tissuġġerixxi li Gardasil jaffettwa l- ħila tiegħek waqt li tkun qed issuq jew waqt li tkun qed tħaddem il- magni.
HOW TO USE GARDASIL
KIF GĦANDEK TUŻA GARDASIL
50 Gardasil is given as an injection by your doctor.
Gardasil jingħata bħala injezzjoni mit- tabib tiegħek.
The person to be vaccinated will receive three doses of the vaccine.
Il- persuna li ser titlaqqam ser tirċievi tliet dożi tal- vaċċin.
First injection: at chosen date Second injection: ideally 2 months after first injection Third injection: ideally 6 months after first injection
L- ewwel injezzjoni: fid- data magħżula It- tieni injezzjoni: idealment xahrejn wara l- ewwel injezzjoni It- tielet injezzjoni: idealment 6 xhur wara l- ewwel injezzjoni