natgillin/translations-raw huggingface dataset:
12-month persistent infection (secondary endpoint)
12- mesečna persistentna okužba (sekundarni opazovani dogodek) HPV- 16 in/ ali 18 * HPV- 16 HPV- 18
HPV-16 and/ or 18* HPV-16 HPV-18
3. 386 11 2. 945 3. 143
14 All endpoints reached statistical significance for HPV-16.
Pri HPV- 16 so vsi opazovani dogodki dosegli statistično pomembnost.
However, in a pre-specified analysis (TVC-2) that was identical to the TVC-1 analysis except that it excluded women with abnormal cytology at study entry, the 12 month persistent infection endpoint for HPV-18 reached statistical significance with vaccine efficacy of 89.9% (97.9% CI:
Učinkovitost cepiva je bila 89, 9% (97, 9% interval zaupanja:
The antibody response to HPV-16 and HPV-18 was measured using a type-specific ELISA which was shown to correlate with the pseudovirion-based neutralisation assay.
15 Protitelesni odziv proti HPV- 16 in HPV- 18 je bil ovrednoten z uporabo genotipsko specifičnih ELISA testov, za katere je bilo dokazana soodvisnost s testom nevtralizacije psevdoviriona.
The GMTs were,
V drugem kliničnem preskušanju (študija 014), izvedenem pri ženskah, starih od 15 do 55 let, se je po cepljenju s tretjim odmerkom cepiva (v 7. mesecu) serokonverzija na oba genotipa 16 in 18 HPV pojavila pri vseh osebah, vendar pa so bili pri ženskah, starejših od 25 let, geometrijski srednji titri nižji.
Sodium chloride (NaCl) Sodium dihydrogen phosphate dihydrate (NaH2PO4.2 H2O) Water for injections
natrijev klorid (NaCl) 16 natrijev dihidrogenfosfat dihidrat (NaH2PO4. 2 H2O) voda za injekcije
If not used immediately, the vaccine should be stored in a refrigerator (2°C – 8°C).
Če ni uporabljeno takoj, ga je treba shraniti v hladilniku (pri temperaturi od 2 °C do 8 °C).
For storage after first opening, see section 6.3.
Za podatke o shranjevanju po prvem odprtju glejte poglavje 6. 3.
16 1 ml of suspension in a vial (type I glass) for 2 doses with a stopper (rubber butyl) in pack sizes of 1, 10 and 100.
1 ml suspenzije v viali (iz stekla tipa I) za 2 odmerka z zamaškom (iz butilne gume) v pakiranjih po 1, 10 in 100.
When using a multidose vial, each 0.5 ml dose should be withdrawn using a sterile needle and syringe; precautions should be taken to avoid contamination of the contents.
Pri uporabi večodmerne viale je treba vsak 0, 5 ml odmerek izvleči s sterilno iglo in brizgo; upoštevati je treba previdnostne ukrepe, da ne pride do onesnaženja vsebine.
The recommended vaccination schedule is 0, 1, 6 months.
19 Priporočena shema cepljenja je 0., 1. in 6. mesec.
The need for a booster dose has not been established (see section 5.1).
Potrebnost obnovitvenega odmerka ni bila dokazana (glejte poglavje 5. 1).
18 It is recommended that subjects who receive a first dose of Cervarix complete the 3-dose vaccination course with Cervarix (see section 4.4).
Pri osebah, ki so bile cepljene s prvim odmerkom cepiva Cervarix priporočamo, da se tudi cepljenje s preostalima dvema odmerkoma opravi s cepivom Cervarix (glejte poglavje 4. 4).
There are no safety, immunogenicity or efficacy data to support interchangeability of Cervarix with other HPV vaccines.
20 Podatki o varnosti, imunogenosti ali učinkovitosti cepljenja v primeru zamenjave cepiva Cervarix z drugimi cepivi proti HPV niso na voljo.
19 Use with other vaccines
Uporaba z drugimi cepivi
The most common adverse reaction observed after vaccine administration was injection site pain which occurred after 78% of all doses.
21 Najpogostejši neželeni učinek po cepljenju je bila bolečina na mestu injiciranja, ki se je pojavila po cepljenju z 78% vseh odmerkov cepiva.
20 Common (≥ 1/ 100 to < 1/ 10) Uncommon (≥ 1/ 1,000 to < 1/ 100)
Zelo pogosti (≥ 1/ 10) Pogosti (≥ 1/ 100 do < 1/ 10) Občasni (≥ 1/ 1. 000 do < 1/ 100)
Clinical studies
22 Klinične študije
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.
Učinkovitost cepiva Cervarix je bila ovrednotena v dveh nadzorovanih, dvojno slepih, randomiziranih kliničnih študijah II. in III. faze, v kateri je bilo skupaj vključenih 19. 778 žensk, starih od 15 do 25 let.
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:
23 V spodnji tabeli je prikazana učinkovitost cepiva Cervarix pri preprečevanju CIN2+, povezane s HPV - 16 in/ ali HPV- 18, kot je bilo ovrednoteno do 15 mesecev po prejemu zadnjega odmerka cepiva ali kontrolne učinkovine in deleže 12- mesečne persistentne okužbe v TVC- 1 kohorti.
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:
Učinkovitost cepiva je bila 89, 9% (97, 9% interval zaupanja:
The antibody response to HPV-16 and HPV-18 was measured using a type-specific ELISA which was shown to correlate with the pseudovirion-based neutralisation assay.
24 Protitelesni odziv proti HPV- 16 in HPV- 18 je bil ovrednoten z uporabo genotipsko specifičnih ELISA testov, za katere je bilo dokazana soodvisnost s testom nevtralizacije psevdoviriona.
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.
Kljub temu so vse osebe ves čas spremljanja (do 18. meseca) ostale seropozitivne na oba genotipa, pri čemer se je vrednost protiteles ohranila na ravni, ki je bila občutno nad vrednostjo titra protiteles, ugotovljeno po naravni okužbi.
23 Bridging the efficacy of Cervarix from young adult women to adolescents
Primerjava učinkovitosti cepiva Cervarix pri mlajših odraslih ženskah in mladostnicah
Sodium chloride (NaCl) Sodium dihydrogen phosphate dihydrate (NaH2PO4.2 H2O) Water for injections
natrijev klorid (NaCl) 25 natrijev dihidrogenfosfat dihidrat (NaH2PO4. 2 H2O) voda za injekcije
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 suspenzije v napolnjeni injekcijski brizgi (steklo tipa I) z batnim zamaškom (butilna guma) z injekcijskimi iglami ali brez v pakiranjih po 1 in 10.
24 A fine white deposit with a clear colourless supernatant may be observed upon storage of the syringe.
Med shranjevanjem napolnjene injekcijske brizge se lahko pojavi fina bela usedlina in bister brezbarven supernatant.
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.
Pred cepljenjem morate vsebino napolnjene injekcijske brizge, preden jo pretresete in po tem, pregledati glede morebitnih tujkov in/ ali neobičajnega fizikalnega videza.
25 ANNEX II
27 DODATEK II
89, rue de l'Institut BE-1330 Rixensart Belgium
89, rue de l' Institut BE- 1330 Rixensart Belgija
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 Belgija
Les Isnes Rue Louis Genonceau, 13 BE-5023 Gembloux Belgium
Les Isnes Rue Louis Genonceau, 13 BE- 5023 Gembloux Belgija
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.
Imetnik dovoljenja za promet mora zagotoviti sistem farmakovigilance, kot je opisan v 2. različici opisani v modulu 1. 8. 1. vloge za pridobitev dovoljenja za promet z zdravilom, ki mora delovati pred pričetkom trženja zdravila in dokler je zdravilo v uporabi.
Risk Management Plan
Načrt obvladovenje tveganja
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
Imetnik dovoljenja za promet z zdravilom se obvezuje, da bo izvedel študije in dodatne farmakovigilančne aktivnosti, navedene v farmakovigilančnem načrtu, kot je dogovorjeno v 2.
27 Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
29 različici načrta obvladovanja tveganja opisanega v modulu 1. 8. 2. vlode za pridobitev dovoljenja za promet z zdravilom in morebitnih naslednjih posodobitvah načrta obvladovanja tveganja, dogovorjenega s 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).
Skladno s smernicami CHMP o sistemu obvadovanja tveganja za zdravila za humano uporabo, je treba posodobljen načrt obvadovanja tveganja vložiti sočasno z naslednjim Periodičnim poročilom o varnosti zdravila.
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
Dodatno je treba predložiti posodobljen načrt obvladovanja tveganja • ob pridobitvi novega obvestila, ki lahko vpliva na obstoječo varnostno specifikacijo, sistem farmakovigilance ali aktivnosti za zmanjševanje tveganja • v 60 dneh po dosegu pomembnega mejnika (v farmakovigilanci ali zmanjševanju tveganja) • na zahtevo EMEA- e
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.
Uradna sprostitev serije: skladno s 114. členom dopolnjene in spremenjene Direktive 2001/ 83/ ES, serijo uradno sprosti državni laboratorij ali laboratorij, določen v ta namen.
28 ANNEX III
30 DODATEK III
30 PARTICULARS TO APPEAR ON THE OUTER PACKAGING MONODOSE VIAL, PACK OF 1, 10, 100
1.
HPV type 16 L1 protein1,2 HPV type 18 L1 protein1,2 1 adjuvanted by AS04 containing:
L1 protein genotipa 16 HPV1, 2 L1 protein genotipa 18 HPV1, 2 1 z adjuvansom AS04, ki vsebuje:
3-O-desacyl-4’ - monophosphoryl lipid A (MPL)2 2
3- O- desacil- 4 ’ - monofosforil lipid A (MPL) 2 2 adsorbiran na hidratirani aluminijev hidroksid (Al( OH) 3)
Sodium chloride Sodium dihydrogen phosphate dihydrate Water for injections
natrijev klorid natrijev dihidrogenfosfat dihidrat voda za injekcije
Suspension for injection 1 vial 1 dose (0.5 ml)
Suspenzija za injiciranje 1 viala 1 odmerek (0, 5 ml)
10 vials 10 x 1 dose (0.5 ml)
10 vial 10 x 1 odmerek (0, 5 ml)
100 vials 100 x 1 dose (0.5 ml)
100 vial 100 x 1 odmerek (0, 5 ml)
Read the package leaflet before use Intramuscular use Shake before use
Pred uporabo pretresite.
Keep out of the reach and sight of children
Cepivo shranjujte nedosegljivo otrokom!
Rue de l’ Institut 89 B-1330 Rixensart, Belgium
Rue de l’ Institut 89 B- 1330 Rixensart, Belgija
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 – pakiranje po 1 EU/ 1/ 07/ 419/ 002 – pakiranje po 10 EU/ 1/ 07/ 419/ 003 – pakiranje po 100
Medicinal product subject to medical prescription
Izdaja cepiva je le na recept.
32 PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIDOSE VIAL, PACK OF 1, 10, 100
1.
Cervarix suspension for injection, multidose Human Papillomavirus vaccine [Types 16, 18] (Recombinant, adjuvanted, adsorbed)
Cervarix suspenzija za injiciranje Adsorbirano rekombinantno cepivo z adjuvansom proti genotipoma 16 in 18 humanih virusov papiloma
Suspension for injection 1 vial 2 doses (1 ml)
Suspenzija za injiciranje 1 viala 2 odmerkA (1 ml)
10 vials 10 x 2 doses (1 ml)
10 vial 10 x 2 odmerka (1 ml)
100 vials 100 x 2 doses (1 ml)
100 vial 100 x 2 odmerka (1 ml)
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 – pakiranje po 1 EU/ 0/ 00/ 000/ 000 – pakiranje po 10 EU/ 0/ 00/ 000/ 000 – pakiranje po 100
INSTRUCTIONS ON USE
NAVODILA ZA UPORABO 37 16.
INFORMATION IN BRAILLE
Sprejeta je utemeljitev, da Braillova pisava ni potrebna.
34 Justification for not including Braille accepted.
38 PODATKI NA ZUNANJI OVOJNINI NAPOLNJENA INJEKCIJSKA BRIZGA Z INJEKCIJSKO IGLO ALI BREZ, PAKIRANJA PO 1, 10
35 PARTICULARS TO APPEAR ON THE OUTER PACKAGING PRE-FILLED SYRINGE WITH OR WITHOUT NEEDLE, PACK OF 1, 10
1.
Suspension for injection in pre-filled syringe 1 pre-filled syringe 1 dose (0.5 ml)
Suspenzija za injiciranje v napolnjeni injekcijski brizgi 1 napolnjena injekcijska brizga 1 odmerek (0, 5 ml)
10 pre-filled syringes 10 x 1 dose (0.5 ml)
10 napolnjenih injekcijskih brizg 10 x 1 odmerek (0, 5 ml)
1 pre-filled syringe + 1 needle 1 dose (0.5 ml)
1 napolnjena injekcijska brizga + 1 injekcijska igla 1 odmerek (0, 5 ml)
10 pre-filled syringes + 10 needles 10 x 1 dose (0.5 ml)
10 napolnjenih injekcijskih brizg + 10 injekcijskih igel 10 x 1 odmerek (0, 5 ml)
1 pre-filled syringe + 2 needles 1 dose (0.5 ml)
1 napolnjena injekcijska brizga + 2 injekcijski igli 1 odmerek (0, 5 ml)
10 pre-filled syringes + 20 needles 10 x 1 dose (0.5 ml)
10 napolnjenih injekcijskih brizg + 20 injekcijskih igel 10 x 1 odmerek (0, 5 ml)
Read the package leaflet before use
Intramuskularna uporaba.
36 Intramuscular use Shake before use
Pred uporabo pretresite.
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 – pakiranje po 1 brez injekcijske igle EU/ 1/ 07/ 419/ 009 – pakiranje po 10 brez injekcijskih igel EU/ 1/ 07/ 419/ 004 – pakiranje po 1 z 1 injekcijsko iglo EU/ 1/ 07/ 419/ 006 – pakiranje po 10 z 10 injekcijskimi iglami EU/ 1/ 07/ 419/ 005 – pakiranje po 1 z 2 injekcijskima iglama EU/ 1/ 07/ 419/ 007 – pakiranje po 10 z 20 injekcijskimi iglami
37 Medicinal product subject to medical prescription
Izdaja cepiva je le na recept.
38 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS MONODOSE VIAL LABEL
41 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH NALEPKA NA ENOODMERNI VIALI
Cervarix Suspension for injection
Cervarix suspenzija za injiciranje
1 dose (0.5 ml)
1 odmerek (0, 5 ml)
39 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS MULTIDOSE VIAL LABEL
42 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH NALEPKA NA VEČODMERNI VIALI
2 doses (1 ml)
1 odmerek (0, 5 ml)
40 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PRE-FILLED SYRINGE LABEL
43 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH NALEPKA NA NAPOLNJENI INJEKCIJSKI BRIZGI
Cervarix Suspension for injection in pre-filled syringe
Cervarix suspenzija za injiciranje v napolnjeni injekcijski brizgi
Read all of this leaflet carefully before you start receiving this vaccine.
Pred začetkom cepljenja natančno preberite navodilo!
Do not pass it on to others.
- Cepivo je bilo predpisano vam osebno in ga ne smete dajati drugim.
What Cervarix is and what it is used for 2.
Kaj je cepivo Cervarix in za kaj ga uporabljamo 2.
Before you receive Cervarix 3.
Kaj morate vedeti, preden boste prejeli cepivo Cervarix 3.
How Cervarix is given 4.
Kako uporabljati cepivo Cervarix 4.
How to store Cervarix 6.
Shranjevanje cepiva Cervarix 6.
WHAT CERVARIX IS AND WHAT IT IS USED FOR
KAJ JE CEPIVO CERVARIX IN ZA KAJ GA UPORABLJAMO
Cervarix is a vaccine intended to protect females against the diseases caused by infection with Human Papillomavirus (HPV) types 16 and 18.
Cepivo Cervarix je namenjeno za zaščito žensk pred boleznimi, ki so posledica okužbe z genotipoma 16 in 18 humanih virusov papiloma (HPV).
- cervical cancer (cancer of the cervix i. e. lower part of the uterus or womb),
- rak materničnega vratu (rak spodnjega dela maternice ali uterusa).
- precancerous cervical lesions (changes in cells of the cervix that have a risk of turning into
- predrakave spremembe na materničnem vratu (spremembe v celicah materničnega vratu iz
cancer).
katerih se lahko razvije rak).
Cervarix will not protect against all types of Human Papillomavirus.
Cepivo Cervarix ne ščiti pred vsemi genotipi humanih virusov papiloma.
HPV types 16 and 18 are responsible for approximately 70% of cervical cancer cases.
Genotipa 16 in 18 HPV sta odgovorna za približno 70% vseh primerov raka materničnega vratu.
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.
Po cepljenju s cepivom Cervarix imunski sistem (naravni obrambni sistem telesa) tvori protitelesa proti genotipoma 16 in 18 HPV.
In clinical trials Cervarix has been shown to prevent HPV types 16 and 18 related diseases in women 15-25 years of age.
Klinična preskušanja so pokazala, da cepivo Cervarix pri ženskah, starih od 15 do 25 let, prepreči pojav bolezni, ki so povezane z genotipoma 16 in 18 HPV.
Cervarix also stimulates production of antibodies in females 10-14 years of age.
Cepivo Cervarix spodbuja tvorbo protiteles tudi pri deklicah, starih od 10 do 14 let.
BEFORE YOU RECEIVE CERVARIX
KAJ MORATE VEDETI, PREDEN BOSTE PREJELI CEPIVO 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.
Cepiva Cervarix ne smete prejeti Oseba cepiva Cervarix ne sme prejeti: • če je alergična na (preobčutljiva za) katerokoli zdravilno učinkovino ali katerokoli drugo sestavino cepiva Cervarix.
The active substances and other ingredients of Cervarix are listed at the end of the leaflet (see section 6).
Zdravilne učinkovine in druge sestavine cepiva Cervarix so navedene
43 • has a severe infection with a high temperature.
46 na koncu tega navodila (glejte poglavje 6).
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
Bodite posebno pozorni pri uporabi cepiva Cervarix Obvestite svojega zdravnika, če ima oseba, ki bo cepljena: • težave s krvavitvami ali hitrim pojavom modric. • katerokoli bolezen, ki zmanjšuje odpornost proti okužbam, npr okužbo z virusom 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.
Kljub cepljenju morate še naprej upoštevati navodila svojega zdravnika o preiskavah brisa materničnega vratu (test Pap - presejalni test za odkrivanje sprememb v celicah materničnega vratu, ki so posledica okužbe s HPV) in drugih preventivnih ter zaščitnih ukrepih.
The duration of protection after vaccination is currently unknown.
Trajanje zaščite po cepljenju trenutno ni znano.
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.
S kliničnimi preskušanji so ugotovili, da se je pri ženskah, starih od 15 do 25 let, zaščita ohranila do 6, 4 let po cepljenju s prvim odmerkom cepiva.
The need for booster dose(s) has not been investigated.
Potrebnost cepljenja z obnovitvenim odmerkom (obnovitvenimi odmerki) ni bila raziskana.
Using other medicines Cervarix may not have an optimal effect if used with medicines that suppress the immune system.
Uporaba drugih zdravil V primeru uporabe zdravil, ki zavirajo imunski sistem, učinek cepiva Cervarix morda ne bo optimalen.
In clinical trials, oral contraceptives (e. g. the pill) did not reduce the protection obtained by Cervarix.
V kliničnih preskušanjih peroralni kontraceptivi (kontracepcijske tablete) niso zmanjšali zaščite, pridobljene s cepivom 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.
Zdravnika ali farmacevta obvestite tudi, če ste bili pred kratkim cepljeni s katerimkoli drugim cepivom.
Pregnancy and breast-feeding There are insufficient data concerning the use of Cervarix during pregnancy.
Nosečnost in dojenje O cepljenju s cepivom Cervarix med nosečnostjo ni dovolj podatkov.
If pregnancy occurs during the course of vaccination your doctor should be consulted.
Če zanosite preden prejmete vse odmerke cepiva Cervarix, se posvetujte s svojim zdravnikom.
It is recommended to postpone vaccination until after completion of the pregnancy.
V tem primeru je priporočljivo, da se cepljenje s preostalimi odmerki cepiva odloži na čas po koncu nosečnosti.
Ask your doctor for advice about breast-feeding before receiving Cervarix.
O dojenju se posvetujte s svojim zdravnikom pred začetkom cepljenja s cepivom Cervarix.
Driving and using machines There is no information on the effect of Cervarix on your ability to drive or use machinery.
Vpliv na sposobnost upravljanja vozil in strojev O vplivu cepiva Cervarix na sposobnost upravljanja vozil in strojev ni podatkov.
HOW CERVARIX IS GIVEN
KAKO UPORABLJATI CEPIVO CERVARIX
Cervarix is intended for females from 10 years of age onwards.
47 Cepivo Cervarix je namenjeno za cepljenje žensk, starejših od 10 let.
A total of three injections will be administered by your doctor or nurse according to the following schedule:
Zdravnik ali medicinska sestra vas bo cepil/ cepila s tremi odmerki cepiva v skladu z naslednjo shemo:
First injection: at chosen date Second injection:
Drugi odmerek:
1 month after first injection Third injection:
Tretji odmerek:
6 months after first injection
6 mesecev po prvem odmerku.
44 If necessary, the vaccination schedule can be more flexible.
Shemo cepljenja se po potrebi lahko tudi prilagodi.
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.
Po cepljenju s prvim odmerkom cepiva Cervarix priporočamo, da se tudi cepljenje s preostalima dvema odmerkoma opravi s cepivom Cervarix (in ne z drugim cepivom proti HPV).
If you forget a return visit for Cervarix:
Če ste pozabili na cepljenje s predvidenim odmerkom cepiva Cervarix:
If you do not finish the complete vaccination course of three injections, you may not get the best response and protection from the vaccination.
Če niste prejeli vseh treh predvidenih odmerkov cepiva, sta odziv na cepljenje in zaščita lahko slabši.
Like all medicines, Cervarix can cause side effects, although not everybody gets them.
Kot vsa zdravila ima lahko tudi cepivo Cervarix neželene učinke, ki pa se ne pojavijo pri vseh cepljenih osebah.
♦ 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
♦ Zelo pogosti (neželeni učinki, ki se lahko pojavijo pri več kot 1 od 10 odmerkov cepiva): • bolečina ali neugodje na mestu injiciranja. • rdečina ali oteklina na mestu injiciranja. • glavobol. • bolečine v mišicah in občutljivost ali slabotnost mišic (ki niso posledica telesne aktivnosti). • utrujenost.
♦ 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)
♦ Pogosti (neželeni učinki, ki se lahko pojavijo pri manj kot 1 od 10, vendar več kot 1 od 100 odmerkov cepiva): • prebavni simptomi, vključno s siljenjem na bruhanje, bruhanjem, drisko in bolečinami v trebuhu. • srbenje, rdeč kožni izpuščaj, koprivnica (urtikarija). • bolečine v sklepih. • zvišana telesna temperatura (≥ 38 °C).