qanastek/EMEA-V3 huggingface dataset:
The efficacy of Cervarix was assessed in two controlled, double-blind, randomised Phase II and III clinical trials that included a total of 19,778 women aged 15 to 25 years.
L- effikaċja ta ’ Cervarix ġiet assessjata f’ żewġ studji tal- Fażijiet II u III randomised, double- blind, u kontrollati (HPV- 001/ 007 u HPV- 008) li ħadu sehem fihom total ta ’ 19, 778 nisa ta ’ bejn il- 15 u l- 25 sena.
The phase II trial (study 001/ 007) enrolled only women who:
Fl- istudju f’ Fażi II (studju 001/ 007) irreġistra biss nisa li:
The primary efficacy endpoint was incident infection with HPV-16 and/ or HPV-18.
L- endpoint ta ’ effikaċja primarja kienet il- frekwenza ta ’ infezzjoni b’ HPV- 16 u/ jew HPV- 18.
The phase III trial (study 008) enrolled women without pre-screening for the presence of HPV infection, i. e. regardless of baseline cytology and HPV serological and DNA status.
Fl- istudju f’ Fażi III (studju 008) ġew irreġistrati nisa mingħajr pre- screening għal preżenza ta ’ infezzjoni b’ HPV i. e bla ma kienu meqjusa ċ- ċitoloġija ta ’ linja bażi u s- seroloġija ta ’ HPV u l- istatus ta ’ DNA.
Cervical Intraepithelial Neoplasia (CIN) grade 2 and 3 was used in the clinical trials as a surrogate marker for cervical cancer.
Neoplażja ġewwa ċ- ċellola ta ’ l- epitelju ċervikali (Cervical Intraepithelial Neoplasia- CIN) grad 2 u 3 intużaw fi studji kliniċi bħala marker ieħor ta ’ kanċer ta ’ l- għonq ta ’ l- utru.
In study 008 the primary analyses of efficacy were conducted in the total vaccinated cohort (TVC-1).
Fi studju 008 l- analiżi primarji ta ’ effikaċja saru fil- cohort kollu ta ’ dawk vaċċinati totalment (TVC- 1).
This cohort included only women who were HPV DNA negative and seronegative to the relevant HPV type (HPV-16 or HPV-18) at study entry and had received at least one dose of Cervarix or the control.
Dan il- cohort inkluda biss nisa li kienu negattivi għal HPV DNA u seronegattivi għat- tipi rilevanti ta ’ HPV (HPV- 16 jew HPV- 18) meta ddaħħlu fl- istudju u li kienu irċevew mill- inqas doża waħda ta ’ Cervarix jew il- kontroll.
The efficacy of Cervarix in the prevention of CIN2+ associated with HPV-16 and/ or HPV-18 as assessed up to 15 months after the last dose of vaccine or control and the rates of 12-month persistent infection in the TVC-1 cohort are presented in the table below:
L- effikaċja ta ’ Cervarix fil- prevenzjoni ta ’ CIN2+ assoċjat ma ’ HPV- 16 u/ jew HPV- 18 kif assessjata sa 15 il- xahar wara l- aħħar doża tal- vaċċin jew kontroll u r- rati ta ’ infezzjoni persistenti wara 12 il - xahar fil- cohort TVC- 1 huma ppreżentati fit- tabella hawn taħt:
Study 008
24 Studju 008
22 TVC-1 analysis except that it excluded women with abnormal cytology at study entry, the 12 month persistent infection endpoint for HPV-18 reached statistical significance with vaccine efficacy of 89.9% (97.9% CI:
Madankollu, f’ analiżi speċifikata minn qabel (TVC- 2), li kienet l - istess bħall- analiżi TVC- 1 barra l- fatt li eskludiet nisa b’ ċitoloġija mhux normali fid- dħul ta ’ l- istudju, l- endpoint għal infezzjoni persistenti wara 12 il- xahar għal HPV- 18 laħqet importanza statistika b’ effikaċja tal- vaċċin ta ’ 89. 9% (97. 9% CI:
In clinical trials, 99.9% of initially seronegative subjects had seroconverted to both HPV types 16 and 18 one month after the third dose.
25 Fi provi kliniċi, 99. 9% ta ’ suġġetti li għall- bidu kienu seronegattivi ġew serokonvertiti kemm għall - HPV tip 16 u kemm għall- HPV tip 18 xahar wara t- tielet doża.
Nevertheless, all subjects remained seropositive for both types throughout the follow-up phase (up to month 18) maintaining antibody levels at an order of magnitude above those encountered after natural infection.
Madankollu, is- suġġetti kollha baqgħu seropożittivi għaż - żewġ tipi matul il- fażi kollu tal- follow- up (sa t- 18 il- xahar) u b’ hekk żammew livelli tal anti- korpi akbar minn dawk li tiltaqa magħhom wara infezzjoni naturali.
23 Bridging the efficacy of Cervarix from young adult women to adolescents
Tnaqqis tad- differenza fl- effikaċja ta ’ Cervarix minn nisa żagħżagħ sa adolexxenti
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, acute and repeated dose toxicity, local tolerance, fertility, embryo-foetal and postnatal toxicity (up to the end of the lactation period).
Informazzjoni li mhix klinika, magħmula fuq studji konvenzjonali ta ’ sigurtà farmakoloġika, effett tossiku akut u minn dożi ripetuti, tolleranza lokali, fertilita`, effett tossiku fuq l- embriju/ fetu u wara t - twelid (sa tmiem il- perjodu tat- treddigħ), ma ’ turi l- ebda periklu speċjali għall- bnedmin.
6.2 Incompatibilities
26 6. 2 Inkompatibilitajiet
0.5 ml of suspension in a pre-filled syringe (type I glass) with a plunger stopper (rubber butyl) with or without needles in pack sizes of 1 and 10.
0. 5 ml suspensjoni f’ f’ siringa mimlija minn qabel (tip I tal- ħġieġ) b’ tapp plunger (butyl rubber) bil - labra jew mingħajrha f’ pakketti ta ’ 1 u 10 siringa.
24 A fine white deposit with a clear colourless supernatant may be observed upon storage of the syringe.
Depożitu fin abjad b’ likwidu ċar u bla kulur jgħum fil- wiċċ jista ’ jidher waqt li s- siringa tkun fil - ħażna.
This does not constitute a sign of deterioration.
Dan ma jfissirx li l- mediċina qed titħassar.
The content of the syringe should be inspected visually both before and after shaking for any foreign particulate matter and/ or abnormal physical appearance prior to administration.
Il- kontenut tas- siringa għandu jiġi ċċekkjat viżwalment kemm qabel u wara li jitħawwad għal xi partiċelli barranin u/ jew xi dehra fiżika mhux normali qabel ma ’ jingħata.
In the event of either being observed, discard the vaccine.
Jekk xi waħda minn dawn tkun osservata, il- vaċċin għandu jintrema.
25 ANNEX II
28 ANNESS II
MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTURI TAS- SUSTANZA BIJOLOĠIKA ATTIVA U DETENTUR TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL- LOTT B.
CONDITIONS OF THE MARKETING AUTHORISATION
KUNDIZZJONIJIET TA 'L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS - SUQ
MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTURI TAS- SUSTANZA BIJOLOĠIKA ATTIVA U DETENTUR TA ’ L - AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL- LOTT
89, rue de l'Institut BE-1330 Rixensart Belgium
89, rue de l' Institut BE- 1330 Rixensart Il- Belġju
GlaxoSmithKline Biologicals SA Parc de la Noire Epine rue Flemming 20-1300 Wavre Belgium
GlaxoSmithKline Biologicals SA Parc de la Noire Epine rue Flemming 20- 1300 Wavre Il- Belġju
Les Isnes Rue Louis Genonceau, 13 BE-5023 Gembloux Belgium
Les Isnes Rue Louis Genonceau, 13 BE- 5023 Gembloux Il- Belġju
CONDITIONS OF THE MARKETING AUTHORISATION
B KUNDIZZJONIJIET TA 'L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
The MAH must ensure that the system of pharmacovigilance, as described in version 2 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.
L- MAH għandu jiżgura li s- sistema ta ’ farmakoviġilanza, kif deskritta f’ verżjoni 2 ippreżentata fit - Taqsima 1. 8. 1 ta ’ l- Applikazzjoni għall- Awtorizzazzjoni għat- Tqegħid fis- Suq, qiegħda f’ postha u tiffunzjona qabel ma ’ l- prodott jitqiegħed fis- suq u waqt li l- prodott ikun fis- suq.
Risk Management Plan
Pjan dwar il- Maniġġjar ta ’ Riskju
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 2 of the Risk Management Plan (RMP) presented in
L- MAH jimpenja ruħu li jwettaq l- istudji u l- attivitajiet addizzjonali ta ’ farmakoviġilanza dettaljati fil - Pjan ta ’ Farmakoviġilanza, kif miftiehem fil- verżjoni 1. 2 tal- Pjan dwar il- Maniġġjar ta ’ Riskju (RMP)
27 Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
30 ippreżentat fit- Taqsima 1. 8. 2 ta ’ l- Applikazzjoni għall- Awtorizzazzjoni għat- Tqegħid fis- Suq u fl - aġġornamenti sussegwenti tal- RMP mifthema mil- 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).
L- RMP aġġornat għandu jiġi ppreżentat fl- istess żmien tar- Rapport Perjodikament Aġġornat dwar Sigurta` (PSUR) li jmiss, skond il- linji gwida tal- CHMP dwar Sistemi għal- Maniġġjar ta ’ Riskji għal - prodotti mediċinali għall- użu fil- bniedem.
In addition, an updated RMP should be submitted • 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
Barra minn hekk, RMP aġġornat għandu jiġi ppreżentat: • Meta tasal informazzjoni ġdida li jista ’ jkollha effett fuq l- ispeċifikazzjoni tas- sigurta` kurrenti, fuq il- Pjan ta ’ Farmakoviġilanza kurrenti jew fuq l- attivitajiet għat- tnaqqis tar- riskji. • F’ żmien ta ’ 60 ġurnata wara li tkun intlaħqet xi mira importanti (ta ’ farmakoviġilanza jew ta ’ tnaqqis ta '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.
Ħruġ tal- lott uffiċjali: skond Artiklu 114 tad- Direttiva 2001/ 83/ EC kif emendata, il- ħruġ tal- lott uffiċjali jsir minn laboratorju ta 'l- Istat jew laboratorju ieħor li jiġi maħtur għal dak il- għan.
28 ANNEX III
31 ANNESS III
30 PARTICULARS TO APPEAR ON THE OUTER PACKAGING MONODOSE VIAL, PACK OF 1, 10, 100
33 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA KUNJETT B’ DOŻA WAĦDA, PAKKETT TA ’ 1, 10, 100
Cervarix suspension for injection Human Papillomavirus vaccine [Types 16, 18] (Recombinant, adjuvanted, adsorbed)
Cervarix, suspensjoni għall- injezzjoni Vaċċin tal- Papillomavirus Uman [Tipi 16 u 18] (Rikombinanti, imsaħħaħ, adsorbit)
HPV type 16 L1 protein1,2 HPV type 18 L1 protein1,2 1 adjuvanted by AS04 containing:
Proteina HPV tat- tip 16 LI1, 2 Proteina HPV tat- tip 18 LI1, 2 1 imsaħħaħ b’ AS04 li fih:
3-O-desacyl-4’ - monophosphoryl lipid A (MPL)2 2
3- O- desacyl- 4 ’ - monophosphoryl lipid A (MPL) 2 2 adsorbit fuq aluminium hydroxide, idratat, (Al( OH) 3)
0.5 milligrams Al3+ in total
50 mikrogrammi total ta ’ 0. 5 milligrammi Al3+
Sodium chloride Sodium dihydrogen phosphate dihydrate Water for injections
Sodium chloride Sodium dihydrogen phosphate dihydrate Ilma għall- injezzjonijiet
Suspension for injection 1 vial 1 dose (0.5 ml)
Suspensjoni għall- injezzjoni Kunjett wieħed Doża waħda (0. 5 ml)
10 vials 10 x 1 dose (0.5 ml)
10 kunjetti 10 dożi x 1 (0. 5 ml)
100 vials 100 x 1 dose (0.5 ml)
100 kunjett 100 doża x 1 (0. 5 ml)
Read the package leaflet before use Intramuscular use Shake before use
Għal użu fil- muskoli Ħawwad sew qabel tużah
Store in a refrigerator Do not freeze Store in the original package in order to protect from light
Aħżen fi friġġ Tiffriżax Aħżen fil- pakkett oriġinali biex tħarsu mid- dawl
Dispose of in accordance with local regulations
Armi l- mediċina skond ir- regoli tal- lokal
EU/ 1/ 07/ 419/ 001 – pack of 1 EU/ 1/ 07/ 419/ 002 – pack of 10 EU/ 1/ 07/ 419/ 003 – pack of 100
EU/ 1/ 07/ 419/ 001 - pakkett ta ’ wieħed EU/ 1/ 07/ 419/ 002 - pakkett ta ’ 10 EU/ 1/ 07/ 419/ 003 - pakkett ta ’ 100
LOT:
LOTT:
Justification for not including Braille accepted.
Il- Ġustifikazzjoni biex ma jkunx inkluż il- Braille hija aċċettata
32 PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIDOSE VIAL, PACK OF 1, 10, 100
35 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA KUNJETT B’ ĦAFNA DOŻI, PAKKETT TA ’ 1, 10, 100
Cervarix suspension for injection, multidose Human Papillomavirus vaccine [Types 16, 18] (Recombinant, adjuvanted, adsorbed)
Cervarix, suspensjoni għall- injezzjoni, b’ ħafna dożi Vaċċin tal- Papillomavirus Uman [Tipi 16 u 18] (Rikombinanti, imsaħħaħ, adsorbit)
Suspension for injection 1 vial 2 doses (1 ml)
Suspensjoni għall- injezzjoni Kunjett wieħed 2 dożi (1 ml)
10 vials 10 x 2 doses (1 ml)
10 kunjetti 10 x 2 dożi (1 ml)
100 vials 100 x 2 doses (1 ml)
100 kunjett 100 x 2 dożi (1 ml)
After first opening, use immediately or within 6 hours if stored in a refrigerator
Użah immedjatament kif tiftħu, jew fi żmien 6 sigħat jekk jinħażen fi friġġ.
EU/ 0/ 00/ 000/ 000 – pack of 1 EU/ 0/ 00/ 000/ 000 – pack of 10 EU/ 0/ 00/ 000/ 000 – pack of 100
EU/ 0/ 00/ 000/ 000 - pakkett ta ’ wieħed EU/ 0/ 00/ 000/ 000 - pakkett ta ’ 10 EU/ 0/ 00/ 000/ 000 - pakkett ta ’ 100
34 Justification for not including Braille accepted.
37 Il- Ġustifikazzjoni biex ma jkunx inkluż il- Braille hija aċċettata
35 PARTICULARS TO APPEAR ON THE OUTER PACKAGING PRE-FILLED SYRINGE WITH OR WITHOUT NEEDLE, PACK OF 1, 10
38 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA SIRINGA MIMLIJA MINN QABEL, BI JEW MINGĦAJR LABRA, PAKKETT TA ’ 1, 10
Cervarix suspension for injection in pre-filled syringe Human Papillomavirus vaccine [Types 16, 18] (Recombinant, adjuvanted, adsorbed)
Cervarix, suspensjoni għall- injezzjoni f' siringa mimlija minn qabel Vaċċin Papillomavirus Uman [Tipi 16 u 18] (Rikombinanti, imsaħħaħ, adsorbit)
3-O-desacyl-4’ - monophosphoryl lipid A (MPL)2 2
3- O- desacyl- 4 ’ - monophosphoryl lipid A (MPL) 2 2
0.5 milligrams Al3+ in total
total ta ’ 0. 5 milligrammi Al3+ adsorbit fuq aluminium hydroxide, idratat, (Al( OH) 3)
Suspension for injection in pre-filled syringe 1 pre-filled syringe 1 dose (0.5 ml)
Suspensjoni għall- injezzjoni f’ siringa mimlija minn qabel Siringa waħda mimlija minn qabel Doża waħda (0. 5 ml)
10 pre-filled syringes 10 x 1 dose (0.5 ml)
10 siringi mimlija minn qabel 10 dożi x 1 (0. 5 ml)
1 pre-filled syringe + 1 needle 1 dose (0.5 ml)
1 siringa mimlija minn qabel + labra waħda Doża waħda (0. 5 ml)
10 pre-filled syringes + 10 needles 10 x 1 dose (0.5 ml)
10 siringi mimlija minn qabel + 10 labriet 10 dożi x 1 (0. 5ml)
1 pre-filled syringe + 2 needles 1 dose (0.5 ml)
1 siringa mimlija minn qabel + 2 labriet Doża waħda (0. 5ml)
10 pre-filled syringes + 20 needles 10 x 1 dose (0.5 ml)
10 siringi mimlija minn qabel + 20 labra 10 dożi x 1 (0. 5ml)
Read the package leaflet before use
Aqra l- fuljett ta ’ tagħrif qabel l- użu.
36 Intramuscular use Shake before use
39 Għal użu fil- muskoli Ħawwad sew qabel tużah
EU/ 1/ 07/ 419/ 008 – pack of 1 without needle EU/ 1/ 07/ 419/ 009 – pack of 10 without needle EU/ 1/ 07/ 419/ 004 – pack of 1 with 1 needle EU/ 1/ 07/ 419/ 006 – pack of 10 with 10 needles EU/ 1/ 07/ 419/ 005 – pack of 1 with 2 needles EU/ 1/ 07/ 419/ 007 – pack of 10 with 20 needles
EU/ 1/ 07/ 419/ 008 - pakkett ta ’ wieħed mingħajr labra EU/ 1/ 07/ 419/ 009 - pakkett ta ’ 10 mingħajr labra EU/ 1/ 07/ 419/ 004 - pakkett ta ’ 1 b' labra waħda EU/ 1/ 07/ 419/ 006 - pakkett ta ’ 10 b’ 10 labriet EU/ 1/ 07/ 419/ 005 - pakkett ta ’ 1 b’ 2 labriet EU/ 1/ 07/ 419/ 007 - pakkett ta ’ 10 b’ 20 labra
37 Medicinal product subject to medical prescription
Prodott mediċinali jingħata bir- riċetta tat- tabib.
38 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS MONODOSE VIAL LABEL
41 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN TIKKETTA TAL- KUNJETT B’ DOŻA WAĦDA
Cervarix Suspension for injection
Cervarix Suspensjoni għall- injezzjoni
1 dose (0.5 ml)
Doża waħda (0. 5 ml)
39 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS MULTIDOSE VIAL LABEL
42 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN TIKKETTA TAL- KUNJETT B’ ĦAFNA DOŻI
2 doses (1 ml)
2 dożi (1 ml)
40 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PRE-FILLED SYRINGE LABEL
43 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN TIKKETTA TAS- SIRINGA MIMLIJA MINN QABEL
Cervarix Suspension for injection in pre-filled syringe
Cervarix Suspensjoni għall- injezzjoni f' siringa mimlija minn qabel
42 PACKAGE LEAFLET:
45 FULJETT TA ’ TAGĦRIF:
Cervarix suspension for injection Human Papillomavirus vaccine [Types 16, 18] (Recombinant, adjuvanted, adsorbed)
Cervarix, suspensjoni għall- injezzjoni Vaċċin tal- Papillomavirus Uman [Tipi 16 u 18] (Rikombinanti, imsaħħah, adsorbit)
Read all of this leaflet carefully before you start receiving this vaccine.
Aqra sew dan il- fuljett kollu qabel tibda tuża din il- mediċina.
What Cervarix is and what it is used for 2.
X’ inhu Cervarix u għalxiex jintuża 2.
Before you receive Cervarix 3.
Qabel ma tieħu Cervarix 3.
How Cervarix is given 4.
Kif għandek tieħu Cervarix 4.
How to store Cervarix 6.
Kif taħżen Cervarix 6.
WHAT CERVARIX IS AND WHAT IT IS USED FOR
X’ INHU CERVARIX U GĦALXIEX JINTUŻA
Cervarix is a vaccine intended to protect females against the diseases caused by infection with Human Papillomavirus (HPV) types 16 and 18.
Cervarix hu vaċċin li qiegħed biex jipproteġi lil nisa kontra mard kawżat mill- infezzjoni bil - Papillomavirus (HPV) tat- tipi 16 u 18.
These diseases include:
Dan il- mard jinkludi:
- cervical cancer (cancer of the cervix i. e. lower part of the uterus or womb),
- kanċer ċervikali (kanċer fl- għonq ta ’ l- utru i. e in- naħa t’ isfel ta ’ l- utru),
- precancerous cervical lesions (changes in cells of the cervix that have a risk of turning into
- feriti fl- għonq ta ’ l- utru mhux normali u ta ’ qabel il- kanċer (bidliet fiċ- ċelluli fl- għonq ta ’ l- utru
cancer).
b’ riskju li jwasslu għal kanċer).
Cervarix will not protect against all types of Human Papillomavirus.
Cervarix mhuwiex protezzjoni kontra t- tipi kollha tal- Papillomavirus Uman.
HPV types 16 and 18 are responsible for approximately 70% of cervical cancer cases.
It- tipi 16 u 18 ta ’ HPV huma l- kaġun ta ’ madwar 70% tal- każi ta ’ kanċer ċervikali.
When a female is vaccinated with Cervarix, the immune system (the body’ s natural defence system) will make antibodies against HPV types 16 and 18.
Meta mara titlaqqam b’ Cervarix, is- sistema immunitarja tal- ġisem (is- sistema ta ’ difiża naturali tal - ġisem) tipproduċi anti- korpi kontra t- tipi 16 u 18 ta ’ HPV.
In clinical trials Cervarix has been shown to prevent HPV types 16 and 18 related diseases in women 15-25 years of age.
Provi kliniċi wrew li dawn l- anti- korpi jipproteġu nisa ta ’ bejn il- 15 u l- 25 sena kontra mard relatat mat- tipi 16 u 18 ta ’ HPV.
Cervarix also stimulates production of antibodies in females 10-14 years of age.
Cervarix jistimola wkoll il- produzzjoni ta ’ anti- korpi f’ nisa ta ’ bejn l- 10 snin u l- 14– il sena.
Cervarix is not infectious and so, it cannot cause HPV related diseases.
Cervarix mhux infettiv u għalhekk ma jistax jikkaġuna xi mard relatat ma HPV.
Cervarix is not used to treat HPV related diseases already present at the time of vaccination.
Cervarix ma jintużax biex jikkura mard relatat ma ’ HPV li digà jkun hemm fiż- żmien tal - vaċċinazzjoni
Cervarix should be used in accordance with official guidelines.
Cervarix għandu jintuża skond il- linji gwida uffiċjali.
BEFORE YOU RECEIVE CERVARIX
QABEL MA TIEĦU CERVARIX
Cervarix should not be given if the person to be vaccinated: • is allergic (hypersensitive) to any of the active substances or any of the other ingredients of Cervarix.
Cervarix m’ għandux jingħata jekk il- persuna li se tieħu l- vaċċinazzjoni: • hi allerġika (uriet sensittività eċċessiva) għal xisustanzi attivi jew għal xi sustanzi oħra li fih Cervarix.
The active substances and other ingredients of Cervarix are listed at the end of the leaflet (see section 6).
Is- sustanzi attivi u sustanzi oħra li fih Cervarix huma mniżżla f’ lista fl- aħħar tal- fuljett (ara sezzjoni 6).
Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue.
Sinjali ta ’ reazzjoni allerġika jistgħu ikunu raxx fil- ġilda, qtugħ ta ’ nifs u nefħa fil- wiċċ jew fl- ilsien.
43 • has a severe infection with a high temperature.
46 • għandha xi infezzjoni qawwija b’ deni għoli.
It might be necessary to postpone the vaccination until recovery.
Jista ’ jkun hemm bżonn li l- vaċċinazzjoni titħalla għal xi darb ’ oħra sakemm tgħaddi l- infezzjoni.
A minor infection such as a cold should not be a problem, but talk to the doctor first.
Infezzjoni żgħira bħal riħ m’ għandhiex tkun problema, iżda tajjeb li dejjem tkellem lit- tabib.
Take special care with Cervarix You should tell the doctor if the person to be vaccinated: • has a bleeding problem or bruises easily. • has any disease which reduces her resistance to infection such as HIV infection
Oqgħod attent ħafna b’ Cervarix Għandek tgħarraf lit- tabib jekk il- persuna li tieħu l- vaċċinazzjoni: • għandha xi problema ta ’ ħruġ ta ’ demm jew titbenġel mix- xejn. • għandha xi marda li tnaqqas ir- reżistenza tagħha għall– infezzjoni bħal infezzjoni b’ HIV
As with all vaccines, Cervarix may not fully protect all people who are vaccinated.
Cervarix, bħal vaċċini kollha, jistà ma jipproteġix għal kollox in- nies kollha li jkunu vaċċinati.
Cervarix does not protect people from diseases caused by infection with HPV types 16 or 18 if they are already infected with Human Papillomavirus type 16 or 18 at the time of vaccination.
Cervarix ma jagħtix protezzjoni minn mard ikkawżat minn HPV tipi 16 jew 18 jekk dawn diġà jkunu infettati bil- Papillomavirus Uman tip 16 jew 18 fiż- żmien tal- vaċċinazzjoni.
Although vaccination may protect you against cervical cancer, it is not a substitute for regular cervical screening.
Għalkemm il- vaċċinazzjoni tista ’ tipproteġik kontra l- kanċer ċervikali, din ma tissostitwix l- iscreening regolari ta ’ l- għonq ta ’ l- utru.
You should continue to follow your doctor’ s advice on cervical smear/ Pap test (test to screen for changes in cells of the cervix caused by an HPV infection) and preventative and protective measures.
Għandek tkompli miexi fuq il- parir tat- tabib tiegħek dwar il- ħtieġa ta ’ smear/ Pap test u miżuri oħra ta ’ prevenzjoni u protezzjoni.
As Cervarix will not protect against all types of Human Papillomavirus, appropriate precautions against exposure to HPV and sexually transmitted diseases should continue to be used.
Billi Cervarix ma jipproteġix kontra t- tipi kollha tal- Papillomavirus Uman, għandhom ikomplu jittieħdu prekawzjonijiet appropjati kontra espożizzjoni għal HPV u mard li jittieħed sesswalment.
Cervarix will not protect against other diseases that are not caused by Human Papillomavirus.
Cervarix ma jagħtix protezzjoni kontra mard ieħor mhux ikkawżat mill- Papillomavirus Uman.
The duration of protection after vaccination is currently unknown.
Bħalissa mhux magħruf kemm iddum il- protezzjoni wara l- vaċċinazzjoni.
In clinical trials, sustained protection has been observed in females aged 15 to 25 years for up to 6.4 years after the first dose.
Fi provi kliniċi, kienet osservata protezzjoni dejjiema sa 6. 4 snin f’ nisa ta ’ bejn il- 15 u l- 25 sena wara l- ewwel doża.
The need for booster dose(s) has not been investigated.
Ma ġiex investigat il- bżonn ta ’ doża( i) booster.
Using other medicines Cervarix may not have an optimal effect if used with medicines that suppress the immune system.
Meta tieħu mediċini oħra Cervarix jista ’ ma jkunx effettiv daqs kemm mixtieq jekk jintuża ma ’ mediċini oħra li jrażżnu s - sistema immunitarja.
In clinical trials, oral contraceptives (e. g. the pill) did not reduce the protection obtained by Cervarix.
Fi provi kliniċi, kontraċettivi li jittieħdu mill- ħalq (e. g. il- pillola) ma naqqsux mill- protezzjoni li jagħti Cervarix.
Please tell the doctor if the person to be vaccinated is taking or has recently taken any other medicines, including medicines obtained without a prescription or has recently received any other vaccine.
Jek jogħġbok għarraf lit- tabib jekk il- persuna li għandha tieħu l- vaċċinazzjoni qed tieħu, jew ħadet xi mediċini oħra, inklużi dawk bla riċetta jew jekk reċentement tkun ħadet xi vaċċinazzjoni oħra.
Pregnancy and breast-feeding There are insufficient data concerning the use of Cervarix during pregnancy.
Tqala u Treddigħ Ma hemmx informazzjoni biżżejjed fuq l- użu ta ’ Cervarix waqt it- tqala.
If pregnancy occurs during the course of vaccination your doctor should be consulted.
Jekk toħroġ tqila waqt il- kors tal- vaċċinazzjoni għandek tikkonsulta mat- tabib tiegħek.
It is recommended to postpone vaccination until after completion of the pregnancy.
Huwa irrakkomandat li tipposponi il - vaċċinazzjoni sa wara li tintemm it- tqala.
Ask your doctor for advice about breast-feeding before receiving Cervarix.
Staqsi lit- tabib tiegħek għal parir dwar it- treddigħ qabel ma ’ tieħu Cervarix.
Driving and using machines There is no information on the effect of Cervarix on your ability to drive or use machinery.
Sewqan u tħaddim ta ’ magni Ma hemmx tagħrif dwar l- effett ta ’ Cervarix fuq il- ħila għas- sewqan jew tħaddim ta ’ makkinarju.
HOW CERVARIX IS GIVEN
KIF GĦANDEK TIEĦU CERVARIX
The doctor or nurse will give Cervarix as an injection into the muscle of the upper arm.
It- tabib jew l- infermier jagħtik Cervarix bħala injezzjoni fil- muskolu tal- parti ta ’ fuq tad- driegħ.
Cervarix is intended for females from 10 years of age onwards.
Cervarix huwa intenzjonat għal nisa minn 10 snin il- fuq.
A total of three injections will be administered by your doctor or nurse according to the following schedule:
B’ kollox jingħatawlek tliet injezzjonijiet mit - tabib jew l- infermier tiegħek skond l- iskeda li ġejja:
First injection: at chosen date Second injection:
L- ewwel injezzjoni: f’ data li tiġi magħżula It- tieni injezzjoni: xahar wara l- ewwel injezzjoni
1 month after first injection Third injection:
47 It- tielet injezzjoni:
6 months after first injection
6 xhur wara l- ewwel injezzjoni
44 If necessary, the vaccination schedule can be more flexible.
Jekk ikun hemm bżonn, l- iskeda tal- vaċċinazzjoni tista ’ tkun aktar flessibbli.
Please speak to your doctor for more information.
Jekk jogħġbok kellem lit- tabib tiegħek għal aktar informazzjoni.
When Cervarix is given for the first dose, it is recommended that Cervarix (and not another vaccine against HPV) be given for the complete 3-dose vaccination course.
Huwa irrakkommandat li meta Cervarix jingħata bħala l- ewwel doża, Cervarix (u mhux vaċċin ieħor kontra HPV) jibqa ’ jingħata biex jitkompla l- kors ta ’ vaċċinazzjoni ta ’ 3 dożi.
The vaccine should never be given into a vein.
Il- vaċċin qatt m’ għandu jingħata ġol- vina.
It is important that you follow the instructions of your doctor or nurse regarding return visits.
Jekk tinsa terġa ’ tmur għal vista għal Cervarix Huwa importanti li timxi fuq l- istruzzjonijiet tat- tabib jew l- infermier tiegħek dwar iż- żjarat li jkollok tagħmel.
If you forget to go back to your doctor at the scheduled time, ask your doctor for advice.
Jekk tinsa tmur għand it- tabib meta kien imissek, ħu l- parir tat- tabib.
If you do not finish the complete vaccination course of three injections, you may not get the best response and protection from the vaccination.
Jekk ma tagħmilx it- tliet injezzjonijiet kollha tal- vaċċinazzjoni, jista ’ ma jkollokx l- aħjar riżultat u protezzjoni mixtieqa mill- vaċċinazzjoni.
Like all medicines, Cervarix can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Cervarix jista ’ jkollu effetti sekondarji, għalkemm dawn ma jidhrux fuq kulħadd.
Side effects that occurred during clinical trials with Cervarix were as follows:
Effetti mhux mixtieqa li seħħew waqt provi kliniċi b’ Cervarix kienu kif ġej:
♦ Very common (side effects which may occur in more than 1 per 10 doses of vaccine): • pain or discomfort at the injection site • redness or swelling at the injection site • headache • aching muscles, muscle tenderness or weakness (not caused by exercise) • tiredness
♦ Komuni ħafna (effetti mhux mixtieqa li jistgħu iseħħu f’ aktar minn 1 kull 10 dożi ta ’ vaċċin): • uġigħ jew skonfort fis- sit ta 'l- injezzjoni • ħmura jew nefħa fis- sit ta ’ l- injezzjoni • uġigħ ta ’ ras • uġigħ fil- muskoli, dgħjufija jew nuqqas ta ’ saħħa fil- muskoli (li ma tkunx ġejja mill - eżerċizzju) • għejja
♦ Common (side effects which may occur in less than 1 per 10 but more than 1 per 100 doses of vaccine): • gastrointestinal symptoms including nausea, vomiting, diarrhoea and abdominal pain • itching, red skin rash, hives (urticaria) • joint pain • fever (≥ 38°C)
♦ Komuni (effetti mhux mixtieqa li jistgħu jiġru f’ anqas minn 1 kull 10 iżda aktar minn 1 kull 100 doża ta ’ vaċċin). • sintomi gastrointestinali li jinkludu dardir, rimettar, dijarrea u uġigħ ta ’ żaqq • ħakk, raxx u ħmura fil- ġilda, hives (urtikarja) • uġigħ fil- ġogi • deni (≥38°C)
♦ Uncommon (side effects which may occur in less than 1 per 100 but more than 1 per 1,000 doses of vaccine): • upper respiratory tract infection (infection of the nose, throat or trachea) • dizziness • other injection site reactions such as hard lump, tingling or numbness.
♦ Mhux komuni (effetti mhux mixtieqa li jistgħu jiġru f’ anqas minn 1 kull 100 iżda aktar minn 1 kull 1, 000 doża ta ’ vaċċin): • infezzjoni fl- apparat respiratorju tan- naħa ta ’ fuq (infezzjoni ta ’ l- imnieħer, griżmejn jew trakea) • sturdament • reazzjonijiet oħra fis- sit ta ’ l- injezzjoni bħal xi għoqda iebsa, tnemnin jew titrix.
HOW TO STORE CERVARIX
KIF TAĦŻEN CERVARIX
Do not use Cervarix after the expiry date which is stated on the carton.
Tużax Cervarix wara d- data ta ’ skadenza li tidher fuq il- kaxxa.
The expiry date refers to the last day of that month.
Id- data ta ’ skadenza tirreferi għall - aħħar ġurnata ta ’ dak ix- xahar
Store in a refrigerator (2°C – 8°C).
48 Aħżen fi friġġ (2°Ċ – 8°Ċ).
45 Store in the original package in order to protect from light.
Tiffriżax Żommu fil- kaxxa oriġinali tiegħu biex tħarsu mid- dawl.
What Cervarix contains
X’ fih Cervarix:
- The active substances are:
- Is- sustanzi attivi huma:
0.5 milligrams Al3+ in total
Proteina L1 f’ għamla ta ’ partiċelli mhux infettivi qiishom virus (VLP’ s) prodotta bl- użu ta ’ teknoloġija rikombinanti ta ’ DNA bl- użu ta ’ sistema ta ’ espressjoni Baculovirus li tuża ċelluli Hi- 5 Rix4446 derivat mill- insett Trichoplusia ni.
- The other ingredients are sodium chloride (NaCl), sodium dihydrogen phosphate dihydrate
- Is- sustanzi l- oħra huma sodium chloride (NaC1), sodium dihydrogen phosphate dihydrate
(NaH2PO4.2 H2O) and water for injections.
(NaH2PO4. 2 H2O) u ilma għall- injezzjonijiet.
What Cervarix looks like and contents of the pack
Id- Dehra tal- prodott u d- daqs u l- kontenut tal- pakkett:
Cervarix is a turbid white suspension.
Cervarix hu suspensjoni bajda u mdardra.
Cervarix is available in vials for 1 dose (0.5 ml) in packs of 1, 10 and 100.
Cervarix tista ’ ssibu f’ kunjetti b’ doża 1 (0. 5 ml) f’ kaxxi ta ’ 1, 10 u 100.
Marketing Authorisation Holder and Manufacturer
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq u l- Manifattur:
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
49 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq:
Italia GlaxoSmithKline S. p. A.
50 Suomi/ Finland Italia GlaxoSmithKline Oy GlaxoSmithKline S. p. A.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu/. ------------------------------------------------------------------------------------------------------------------------- The following information is intended for medical or healthcare professionals only:
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - Mediċini (EMEA) http: // www. emea. europa. eu /. --------------------------------------------------------------------------------------------------------------------- It- tagħrif li jmiss qed jingħata biss għall- professjonisti fil- qasam mediku:
A fine white deposit with a clear colourless supernatant may be observed upon storage of the vial.
Depożitu fin abjad b’ likwidu ċar u bla kulur jgħum fil- wiċċ jista ’ jidher waqt li s- siringa tkun maħżuna.
In the event of either being observed, discard the vaccine.
Jekk xi waħda minn dawn tkun osservata, armi l- vaċċin.
48 PACKAGE LEAFLET:
51 FULJETT TA ’ TAGĦRIF:
Cervarix suspension for injection, multidose Human Papillomavirus vaccine [Types 16, 18] (Recombinant, adjuvanted, adsorbed)
Cervarix, suspensjoni għall- injezzjoni, b’ ħafna dożi Vaċċin tal- Papillomavirus Uman [Tipi 16 u 18] (Rikombinanti, imsaħħah, adsorbit)
49 • has a severe infection with a high temperature.
52 • għandha xi infezzjoni qawwija b’ deni għoli.
1 month after first injection Third injection:
53 It- tielet injezzjoni:
50 If necessary, the vaccination schedule can be more flexible.
Jekk ikun hemm bżonn, l- iskeda tal- vaċċinazzjoni tista ’ tkun aktar flessibbli.
Store in a refrigerator (2°C – 8°C).
54 Aħżen fi friġġ (2°Ċ – 8°Ċ).
51 Store in the original package in order to protect from light.
Tiffriżax Żommu fil- kaxxa oriġinali tiegħu biex tħarsu mid- dawl.
Cervarix is available in vials for 2 doses (1 ml) in packs of 1, 10 and 100.
Cervarix tista ’ ssibu f’ kunjetti b’ 2 dożi (1 ml) f’ kaxxi ta ’ 1, 10 u 100.
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
55 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq:
Italia GlaxoSmithKline S.p.A.
56 Suomi/ Finland Italia GlaxoSmithKline Oy GlaxoSmithKline S. p. A.
This leaflet was last approved in.
Dan il- fuljett kien approvat l- aħħar f ’
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/. ------------------------------------------------------------------------------------------------------------------------- The following information is intended for medical or healthcare professionals only:
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - Mediċini (EMEA) http: // www. emea. europa. eu /. --------------------------------------------------------------------------------------------------------------------- It- tagħrif li jmiss qed jingħata biss għall- professjonisti fil- qasam mediku:
The content of the vial should be inspected visually both before and after shaking for any foreign particulate matter and/or abnormal physical appearance prior to administration.
Il- kontenut tal- kunjett għandu jiġi ċċekkjat viżwalment kemm qabel u wara li jitħawwad għal xi partiċelli barranin u/ jew xi dehra fiżika mhux normali qabel ma ’ jingħata.
54 PACKAGE LEAFLET:
57 FULJETT TA ’ TAGĦRIF:
Cervarix suspension for injection in pre-filled syringe Human Papillomavirus vaccine [Types 16, 18] (Recombinant, adjuvanted, adsorbed)
Cervarix, suspensjoni għall- injezzjoni f’ siringa mimlija minn qabel Vaċċin tal- Papillomavirus Uman [Tipi 16 u 18] (Rikombinanti, imsaħħah, adsorbit)
- cervical cancer (cancer of the cervix i.e. lower part of the uterus or womb),
- kanċer ċervikali (kanċer fl- għonq ta ’ l- utru i. e in- naħa t’ isfel ta ’ l- utru),
- pre cancerous cervical lesions (changes in cells of the cervix that have a risk of turning into
- feriti fl- għonq ta ’ l- utru mhux normali u ta ’ qabel il- kanċer (bidliet fiċ- ċelluli fl- għonq ta ’ l- utru
When a female is vaccinated with Cervarix, the immune system (the body’s natural defence system) will make antibodies against HPV types 16 and 18.
Meta mara titlaqqam b’ Cervarix, is- sistema immunitarja tal- ġisem (is- sistema ta ’ difiża naturali tal - ġisem) jipproduċi anti- korpi kontra t- tipi 16 u 18 ta ’ HPV.
Cervarix also stimulates production of antibodies in females 10-14 years of age.
Cervarix jistimola wkoll il- produzzjoni ta ’ anti- korpi f’ nisa ta ’ bejn l- 10 snin u l- 14 – il sena.
Cervarix is not infectious and so, it cannot cause HPV related diseases.
Cervarix mhuwiex infettiv u għalhekk ma jistax jikkaġuna xi mard relatat ma HPV.
Cervarix is not used to treat HPV related diseases already present at the time of vaccination.
Cervarix ma jintużax biex jikkura mard relatat ma ’ HPV li jkun ġa preżenti waqt il- vaċċinazzjoni.
Cervarix should be used in accordance with official guidelines.
Cervarix għandu jintuża skond il- linja gwida uffiċjali.
Cervarix should not be given if the person to be vaccinated: • is allergic (hypersensitive) to any of the active substances or any of the other ingredients of Cervarix.
Cervarix m’ għandux jingħata jekk il- persuna li se tieħu l- vaċċinazzjoni: • hi allerġika (uriet sensittività eċċessiva) għal xi sustanzi attivi jew għal xi sustanzi oħra li fih Cervarix.
Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue. • has a severe infection with a high temperature.
Sinjali ta ’ reazzjoni allerġika jistgħu ikunu raxx fil- ġilda, qtugħ ta ’ nifs u nefħa fil- wiċċ jew fl- ilsien.
55 Take special care with Cervarix You should tell the doctor if the person to be vaccinated: • has a bleeding problem or bruises easily. • has any disease which reduces her resistance to infection such as HIV infection
Oqgħod attent ħafna b’ Cervarix Għandek tgħarraf lit- tabib jekk il- persuna li tieħu l- vaċċinazzjoni: • għandha xi problema ta ’ ħruġ ta ’ demm jew titbenġel mix- xejn. • għandha xi marda li tnaqqas ir- reżistenza tagħha għall– infezzjoni bħal infezzjoni b’ HIV
You should continue to follow your doctor’s advice on cervical smear/Pap test (test to screen for changes in cells of the cervix caused by an HPV infection) and preventative and protective measures.
Għandek tkompli miexi fuq il- parir tat- tabib tiegħek dwar il- ħtieġa ta ’ smear/ Pap test u miżuri oħra ta ’ prevenzjoni u protezzjoni.
The duration of protection after vaccination is currently unknown.
Bħalissa m’ hux magħruf kemm iddum il- protezzjoni wara l- vaċċinazzjoni.
The need for booster dose(s) has not been investigated.
Ma ġietx investigat il- bżonn ta ’ doża( i) booster.
In clinical trials, oral contraceptives (e.g. the pill) did not reduce the protection obtained by Cervarix.
Fi provi kliniċi, kontraċettivi li jittieħdu mill- ħalq (e. g. il- pillola) ma naqqsux mill- protezzjoni li jagħti Cervarix.
The doctor or nurse will give Cervarix as an injection into the muscle of the upper arm.
It- tabib jew infermier Cervarix bħala injezzjoni fil- muskolu tal- parti ta ’ fuq tad- driegħ.
1 month after first injection Third injection:
59 It- tielet injezzjoni:
If necessary, the vaccination schedule can be more flexible.
Jekk ikun hemm bżonn, l- iskeda tal- vaċċinazzjoni tista ’ tkun aktar flessibbli.
56 When Cervarix is given for the first dose, it is recommended that Cervarix (and not another vaccine against HPV) be given for the complete 3-dose vaccination course.
Huwa irrakkommandat li meta Cervarix jingħata bħala l- ewwel doża, Cervarix (u mhux vaċċin ieħor kontra HPV) jibqa ’ jingħata biex jittkompla l- kors ta ’ vaċċinazzjoni ta ’ 3 dożi.
♦ Common (side effects which may occur in less than 1 per 10 but more than 1 per 100 doses of vaccine): • gastrointestinal symptoms including nausea, vomiting, diarrhoea and abdominal pain • itching, red skin rash, hives (urticaria) • joint pain • fever (≥38°C)
♦ Komuni (effetti mhux mixtieqa li jistgħu jiġru f’ anqas minn 1 kull 10 iżda aktar minn 1 kull 100 doża ta ’ vaċċin). • sintomi gastrointestinali li jinkludu dardir, rimettar, dijarrea u uġigħ ta ’ żaqq • ħakk, raxx u ħmura fil- ġilda, hives (urtikarja) • uġigħ fil- ġogi • deni (≥38°C)
Do not use Cervarix after the expiry date which is stated on the carton.
60 Tużax Cervarix wara d- data ta ’ skadenza li tidher fuq il- kaxxa.
Store in the original package in order to protect from light.
Tiffriżax Żommu fil- kaxxa oriġinali tiegħu biex tħarsu mid- dawl.
57 Medicines should not be disposed of via wastewater or household waste.
Il- mediċini m’ għandhomx jintremew ma ’ l- ilma tad- dranaġġ jew ma ’ l- iskart domestiku.
3-O-desacyl-4’- monophosphoryl lipid A (MPL)3 3
3- O- desacyl- 4 ’ - monophosphoryl lipid A (MPL) 3 3 adsorbit fuq aluminium hydroxide idratat, (Al( OH) 3) 4
0.5 milligrams Al3+ in total
Proteina L1 f’ għamla ta ’ partiċelli mhux infettivi qieshom virus (VLP’ s) prodotta bl- użu ta ’ teknoloġija rikombinanti ta ’ DNA bl- użu ta ’ sistema ta ’ espressjoni Baculovirus li tuża ċelluli Hi- 5 Rix4446 derivat mill- insett Trichoplusia ni.
Suspension for injection in pre-filled syringe.
Suspensjoni għall- injezzjoni f’ siringa mimilija minn qabel.
Cervarix is a turbid white suspension.
Cervarix hija suspensjoni bajda u mdardra.
Cervarix is available in pre-filled syringes with or without needles in packs of 1 and 10.
Cervarix tista ’ ssibu f’ kunjetti f’ siringi mimlijin minn qabel bil- labar jew mingħajr labar f’ pakketti ta ’ 1 u ta ’ 10
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
61 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq:
Italia GlaxoSmithKline S.p.A.
62 Suomi/ Finland Italia GlaxoSmithKline Oy GlaxoSmithKline S. p. A.
This leaflet was last approved in
Dan il- fuljett kien approvat f ’
A fine white deposit with a clear colourless supernatant may be observed upon storage of the syringe.
Depożitu fin abjad b’ likwidu ċar u bla kulur tgħum fil- wiċċ jista ’ jidher waqt li s- siringa tkun maħżuna.
The content of the syringe should be inspected visually both before and after shaking for any foreign particulate matter and/or abnormal physical appearance prior to administration.
Il- kontenut tas- siringa għandu jiġi ċċekkjat viżwalment kemm qabel u wara li jitħawwad għal xi partiċelli barranin u/ jew xi dehra fiżika mhux normali qabel ma ’ jingħata.
Invented Name
Isem inventat Qawwa
Strength
Għamla farmaċewtika
Pharmaceutical form Route of administration Packaging
Mnejn jingħata
Powder and solvent for Subcutaneous use Powder: vial (glass) solution for injection Solvent: pre-filled syringe (glass)
Trab u solvent għal soluzzjoni Użu għal taħt il- ġilda għall- injezzjoni
1 vial + 1 pre-filled syringe + 2 injection needles + 2 alcohol swabs
1 kunjett + 1 siringa mimlija għal - lest + 2 labra ta 'l- injezzjoni + 2 ċraret bl- alkoħol
Powder and solvent for Subcutaneous use solution for injection
Trab u solvent għal soluzzjoni Użu għal taħt il- ġilda għall- injezzjoni
Powder: vial (glass) Solvent: pre-filled syringe (glass)
trab: kunjett; solvent: siringa mimlija għal- lest
7 vials + 7 pre-filled syringes + 14 injection needles + 14 alcohol swabs
7 kunjett + 7 siringa mimlija għal - lest + 14 labra ta 'l- injezzjoni + 14 ċraret bl- alkoħol
NAME OF THE MEDICINAL PRODUCT
1 ISEM TAL- PRODOTT MEDIĊINALI 1.
Cetrotide 0.25 mg powder and solvent for solution for injection
Cetrotide 0. 25 mg trab u solvent għal soluzzjoni għall- injezzjoni.
QUALITATIVE AND QUANTITATIVE COMPOSITION
GĦAMLA KWALITTATIVA U KWANTITATTIVA
1 vial contains:
Fjala waħda tinkludi:
0.26 - 0.27 mg cetrorelix acetate equivalent to 0.25 mg cetrorelix.
0. 26 - 0. 27 mg cetrorelix acetate ekwivalenti għall- 0. 25 mg cetrorelix.
After reconstitution with the solvent provided, the concentration of cetrorelix is 0.25 mg/ ml.
Wara t- taħlita mas- solvent provdut, il- konċentrazzjoni ta ’ cetrorelix hi ta ’ 0. 25 mg/ ml.
Excipients:
Sustanzji mhux attivi:
54.80 mg mannitol.
54. 80mg mannitol
For a full list of excipients, see section 6.1.
Għal lista completa ta ’ sustanzi mhux attivi, ara sezzjoni 6. 1.
Appearance of the powder: white lyophilized pellet Appearance of the solvent: clear colourless solution
Apparenza tat- trab: pelitts bojod lajofiliżjati Apparenza tas- solvent għal soluzzjoni: soluzzjoni ċara mingħajr kulur.
The pH of the reconstituted solution is 4.0 – 6.0
Il - pH tas- soluzzjoni rrikostitut huwa 4. 0 – 6. 0
Prevention of premature ovulation in patients undergoing a controlled ovarian stimulation, followed by oocyte pick-up and assisted reproductive techniques.
Prevenzjoni ta ’ ovulazzjoni prematura f’ pazjenti li għaddejjin minn stimulazzjoni kontrollata ta ’ l - ovarji, segwita minn ġbir ta ’ l- ooċit u minn teknika ta ’ riproduzzjoni assistita.
In clinical trials Cetrotide 0.25 mg was used with human menopausal gonadotropin (HMG), however, limited experience with recombinant FSH suggested similar efficacy.
F’ eżamijiet kliniċi Cetrotide 0. 25 mg intuża mal- gonadotropin uman tal- menopawża (HMG), iżda l - esperjenza limitata ma ’ l- FSH rikombinanti tissuġġerixxi effiċjenza simili.
Cetrotide 0.25 mg should only be prescribed by a specialist experienced in this field.
Cetrotide 0. 25 mg għandu jiġi preskritt biss minn speċjalista espert f’ dan il- qasam.
Cetrotide 0.25 mg is for subcutaneous injection into the lower abdominal wall.
Cetrotide 0. 25 mg jingħata permezz ta ’ injezzjoni għal taħt il- ġilda fil- parti t’ isfel tal- membrana ta ’ l - addome.
The following injections may be self-administered as long as the patient is made aware of the signs and symptoms that may indicate hypersensitivity, the consequences of such a reaction and the need for immediate medical intervention.
L- ewwel amministrazzjoni ta ’ Cetrotide għandha sseħħ taħt is- superviżjoni ta ’ tabib u taħt kundizzjonijiet fejn il- kura għal rejazzjonijiet psewdo- allerġiċi li jistgħu jinqalgħu tkun disponibbli immedjatament. Dawn l- injezzjonijiet li jingħataw wara jistgħu jittieħdu mill- pazjent stess sakemm dan jingħata għarfien tas- sinjali u tas- sintomi li jistgħu jindikaw sensittività eċċessiva, il- konsegwenzi ta ’ din it- tip ta ’ reazzjoni u l- bżonn ta ’ intervent mediku immedjat.
The contents of 1 vial (0.25 mg cetrorelix) are to be administered once daily, at 24 h intervals, either in the morning or in the evening.
Il- kontenut ta ’ fjala waħda (0. 25 mg cetrorelix) irid jingħata darba kuljum, b’ intervalli ta ’ 24 siegħa, jew filgħodu jew filgħaxija.
Following the first administration, it is advised that the patient be kept under medical supervision for 30 minutes to ensure there is no allergic/ pseudo-allergic reaction to the injection.
Wara li jingħata għall- ewwel darba, hu suġġerit li l- pazjent jinżamm taħt osservazzjoni medika għal 30 minuta biex ikun ċert li m’ hemm l- ebda rejazzjoni allerġika/ psewdo - allerġika għall- injezzjoni.
Facilities for the treatment of such reactions should be immediately available.
Il- faċilitajiet għat- trattament ta ’ dawn ir- rejazzjonijiet għandhom ikunu disponibbli immedjatament.
2 Administration in the morning:
2 Kif tingħata l- injezzjoni filgħodu:
Treatment with Cetrotide 0.25 mg should commence on day 5 or 6 of ovarian stimulation (approximately 96 to 120 hours after start of ovarian stimulation) with urinary or recombinant gonadotropins and is to be continued throughout the gonadotropin treatment period including the day of ovulation induction.
It- trattament b’ Cetrotide 0. 25 mg għandu jibda fil- 5 jew 6 ġurnata ta ’ l- istimulazzjoni ta ’ l- ovarji (madwar 96 sa 120 siegħa wara l- bidu ta ’ l- istimulazzjoni ta ’ l- ovarji) b’ gonadotropini urinarji jew rikombinanti u għandu jitkompla matul il- perjodu ta ’ trattament b’ gonadotropini inkluża l- ġurnata li fiha jkun hemm l- induzzjoni ta ’ l- ovulazzjoni.
Administration in the evening:
Kif tingħata l- injezzjoni filgħaxija:
Treatment with Cetrotide 0.25 mg should commence on day 5 of ovarian stimulation (approximately 96 to 108 hours after start of ovarian stimulation) with urinary or recombinant gonadotropins and is to be continued throughout the gonadotropin treatment period until the evening prior to the day of ovulation induction.
It- trattament b’ Cetrotide 0. 25 mg għandu jibda fil- 5 ġurnata ta ’ l - istimulazzjoni ta ’ l- ovarji (madwar 96 sa 108 siegħa wara l- bidu ta ’ l- istimulazzjoni ta ’ l- ovarji) b’ gonadotropini urinarji jew rikombinanti u għandu jitkompla matul il- perjodu ta ’ trattament b’ gonadotropini sal- lejl ta ’ qabel il- ġurnata li fiha jkun hemm l- induzzjoni ta ’ l- ovulazzjoni.
For instructions on preparation, see section 6.6.
Għall- istruzzjonijiet dwar l- użu u l- immaniġġar ara sezzjoni 6. 6.
• Hypersensitivity to the active substance or any structural analogues of GnRH, extrinsic peptide hormones or to any of the excipients.
• Sensittività eċċessiva għal cetrorelix acetate jew analogi strutturali tal- GnRH, ormoni estrinsiċi tal- peptide jew għal mannitol.
• Pregnancy and lactation.
• Tqala u waqt li qed tredda ’.
• Postmenopausal women.
• F’ nisa wara l- menopawża