natgillin/translations-raw huggingface dataset:
Timing and need of booster dose(s) has not been established.
Vremenski okvir kao ni potreba za dozom(dozama)
In two clinical studies that enrolled males aged 10 to 18 years, 2,617 males received Cervarix and were followed-up with active safety surveillance.
10 do 18 godina, Cervarix je primilo 2617 osoba muškog spola, u kojih se zatim provodilo aktivno praćenje sigurnosti.
(2) TVC: includes all vaccinated subjects (who received at least one dose of vaccine) irrespective of HPV DNA status, cytology and serostatus at baseline.
(2) TVC: uključuje sve cijepljene ispitanike (koji su primili bar jednu dozu cjepiva) neovisno o HPV DNA statusu, citologiji i serostatusu na početku ispitivanja.
The vaccination schedule depends on the age of the subject.
Doziranje Raspored cijepljenja ovisi o dobi primatelja.
Pre-filled syringe EU/1/07/419/004 EU/1/07/419/005 EU/1/07/419/006 EU/1/07/419/007 EU/1/07/419/008 EU/1/07/419/009
Napunjena štrcaljka EU/1/07/419/004 EU/1/07/419/005 EU/1/07/419/006 EU/1/07/419/007 EU/1/07/419/008 EU/1/07/419/009
0.5 ml of suspension in a vial (type I glass) for 1 dose with a stopper (rubber butyl).
Bočica 0,5 ml suspenzije u bočici (staklo tip I) za 1 dozu sa čepom (butilna guma).
PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIDOSE VIAL, PACK OF 1, 10, 100
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VIŠEDOZNA BOČICA, PAKIRANJE OD 1, 10, 100
The TVC-naïve is a subset of the TVC that includes women with normal cytology, and who were HPV DNA negative for 14 oncogenic HPV types and seronegative for HPV-16 and HPV-18 at baseline.
„TVC-neizloženi“ je podskup TVC-a koji uključuje žene sa normalnom citologijom, koje su na početku ispitivanja bile HPV DNA negativne na 14 onkogenih tipova HPV-a i seronegativne na HPV-16 i HPV-18.
The primary efficacy endpoint was incident infection with HPV-16 and/or HPV-18.
Primarna mjera ishoda djelotvornosti bila je slučajna infekcija virusima HPV-16 i/ili HPV-18.
Marketing Authorisation Holder and Manufacturer GlaxoSmithKline Biologicals s.a.
NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET GlaxoSmithKline Biologicals s.a.
Cervarix can be given with a combined booster vaccine containing diphtheria (d), tetanus (T) and pertussis [acellular] (pa) with or without inactivated poliomyelitis (IPV), (dTpa, dTpa -IPV vaccines), with a combined hepatitis A and hepatitis B vaccine (Twinrix) or a hepatitis B vaccine (Engerix B), or with a meningococcal serogroups A, C, W-135, Y tetanus toxoid conjugate vaccine (MenACWY-TT), at a separate injection site (another part of your body, e.g. the other arm) during the same visit.
Cervarix se može primijeniti istodobno uz kombinirano cjepivo za docjepljivanje protiv difterije (d), tetanusa (T), pertusisa [acelularnog] (pa), sa ili bez inaktiviranog poliomijelitisa (IPV), (dTpa, dTpaIPV), ili sa kombiniranim hepatitis A i hepatitis B cjepivom (Twinrix) ili hepatitis B cjepivom (Engerix B), ili s cjepivom protiv meningokoka serogrupe A, C, W-135, Y konjugiranim na tetanusni toksoid (MenACWY-TT), na odvojenim mjestima aplikacije (drugi dio tijela, npr. druga ruka) tijekom iste posjete liječniku.
• redness or swelling at the injection site
• crvenilo ili oticanje na mjestu injiciranja
Table 6: Vaccine efficacy for non-vaccine oncogenic HPV types
Tablica 6: Djelotvornost cjepiva na onkogene tipove HPV-a koji nisu sadržani u cjepivu
Vaccine-induced IgG Geometric Mean Titres (GMT) were well above titres observed in women previously infected but who cleared HPV infection (natural infection).
Cjepivom inducirani geometrijski srednji titar (GMT) IgG protutijela bio je daleko viši od titara u prethodno zaraženih žena u kojih se
• itching, red skin rash, hives (urticaria)
• svrbež, crveni osip kože, urtikarija • bol u zglobovima
At the 84-month time point, i.e. 78 months after completion of the full vaccination course, 99.3% and 95.9% of initially seronegative women remained seropositive for anti-HPV-16 and anti-HPV-18 antibodies, respectively.
U 84. mjesecu, tj. 78 mjeseci nakon dovršetka cijelog ciklusa cijepljenja, 99,3% odnosno 95,9% početno seronegativnih žena ostalo je seropozitivno na anti
In all clinical trials individuals who had received immunoglobulin or blood-derived products within 3 months prior to the first vaccine dose were excluded.
4.5 Interakcije s drugim lijekovima i drugi oblici interakcija Osobe koje su u posljednja 3 mjeseca prije cijepljenja prvom dozom cjepiva primale imunoglobuline ili krvne derivate bile su isključene iz svih kliničkih ispitivanja.
Based on the HPV type assignment post-hoc analysis, there was 1 CIN2+ case in the vaccine group versus 92 cases in the control group (Efficacy 98.9% (95% CI: 93.8;100)) and no CIN3+ case in the vaccine group versus 22 cases in the control group (Efficacy 100% (95% CI: 81.8;100)) at the end of study analysis.
92 slučajeva u kontrolnoj grupi (djelotvornost 98,9% (95% CI: 93,8; 100)) i bez CIN3+ slučajeva u cijepljenoj grupi naprema 22 slučajeva u kontrolnoj grupi (djelotvornost 100% (95% CI : 81,8; 100)) u analizi na kraju ispitivanja.
Cervarix is available in 1 dose vials (0.5 ml) in packs of 1, 10 and 100.
Cervarix je dostupan u jednodoznim bočicama (0,5 ml) u pakiranjima od 1, 10 i 100.
In clinical studies that enrolled girls and women aged from 10 up to 72 years (of which 79.2% were aged 10-25 years at the time of enrolment), Cervarix was administered to 16,142 females whilst 13,811 females received control.
79,2% u vrijeme uključivanja bilo u dobi 10-25 godina), Cervarix je primijenjen u 16 142 djevojčice i žene, dok je 13 811 djevojčica i žena primilo kontrolno cjepivo.
METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use Intramuscular use
NAČIN I PUT(EVI) PRIMJENE LIJEKA Prije uporabe pročitajte uputu o lijeku.
An anamnestic immune response to HPV-16 and HPV-18 (by ELISA) was observed one week and one month after the challenge dose, GMTs one month after the challenge dose exceeded those observed one month after the primary 3-dose vaccination.
Anamnestički imunološki odgovor na HPV 16 i 18 (ELISA) uočen je jedan tjedan i jedan mjesec nakon primjene dodatne doze.
HPV-16/18 endpoint
HPV-16/18 ishod
Vaccine efficacy against high grade cervical lesions associated with HPV-16/18 observed in TVC at end of study is presented in Table 3.
Djelotvornost cjepiva protiv cervikalnih lezija visokog stupnja, povezanih sa HPV-16/18, a koje su uočene u TVC na kraju ispitivanja, prikazana je u Tablici 3.
Vaccine efficacy against the primary endpoint CIN2+at the end of study is presented in Table 1.
Djelotvornost cjepiva prema primarnom ishodu CIN 2+ prikazana je u Tablici 1.
A fine white deposit with a clear colourless supernatant may be observed upon storage of the syringe.
Tijekom čuvanja štrcaljke može se opaziti fini bijeli talog s bistrim bezbojnim supernatantom.
CIN2+ associated with HPV-16 and HPV-18 individually was demonstrated.
Dodatno, statistički značajna djelotvornost cjepiva za CIN2+ povezana sa HPV-16 i HPV-18 je individualno dokazana.
Twelve-month persistent infection was evaluated as additional efficacy endpoint.
Kao dodatna mjera ishoda djelotvornosti procjenjivana je perzistentna infekcija tijekom 12 mjeseci.
In the placebo group, there were 4 cases of 6-month persistent infection and 1 case of 12-month persistent infection.
6-mjesečne perzistentne infekcije i 1 slučaj 12-mjesečne perzistentne infekcije.
(2) mean follow-up of 44 months post dose 1
(2) prosječni period praćenja od 44 mjeseca nakon 1. doze
Cervical Intraepithelial Neoplasia (CIN) grade 2 and 3 (CIN2/3) and cervical adenocarcinoma in situ (AIS) were used in the clinical trials as surrogate markers for cervical cancer.
Cervikalna intraepitelna neoplazija (CIN) stupnja 2 i 3 (CIN 2/3) i cervikalni adenokarcinom in situ
Human Papillomavirus1 type 18 L1 protein2,3,4
20 mikrograma humani papilomavirus1 tip 18 L1 protein2,3,4
(3) mean follow-up of 40 months post dose 3
(3) prosječni period praćenja od 40 mjeseci nakon 3. doze
(96.1% CI: 0.3;98.1) against CIN3+.
(95% CI: 80,5; 100).
GlaxoSmithKline s.r.o.
GlaxoSmithKline S.p.A.
Vaccine efficacy against virological endpoints (6-month and 12-month persistent infection) associated with HPV-16/18 observed in the ATP cohort at the end of study is presented in Table 2.
Djelotvornost cjepiva protiv viroloških ishoda (6-mjesečna i 12-mjesečna perzistentna infekcija) povezana sa HPV-16/18, uočena u ATP kohorti na kraju ispitivanja, prikazana je u Tablici 2.
1 ml of suspension in a vial (type I glass) for 2 doses with a stopper (rubber butyl).
Višedozna bočica 1 ml suspenzije u bočici (staklo tip I) za 2 doze sa čepom (butilna guma).
In the event-triggered analysis, vaccine efficacy against CIN1 associated with HPV 16/18 observed in the ATP cohort was 94.1% (96.1% CI: 83.4;98.5).
U događajem potaknutoj analizi, djelotvornost cjepiva protiv CIN1 povezanim sa HPV 16/18, uočena u ATP kohorti, bila je 94,1% (96,1% CI: 83,4; 98,5).
Sodium dihydrogen phosphate dihydrate (NaH2PO4.2 H2O) Water for injections
6.1 Popis pomoćnih tvari natrijev klorid (NaCl) natrijev dihidrogenfosfat dihidrat (NaH2PO4×2 H2O) voda za injekcije
Animal studies have shown that the efficacy of L1 VLP vaccines is largely mediated by the development of a humoral immune response.
Ispitivanja provedena na životinjama pokazala su da je djelotvornost cjepiva s L1
The efficacy results at the event-triggered analysis were 94.3% (96.1% CI: 91.5;96.3) against 6-month persistent infection and 91.4% (96.1% CI: 89.4;95.4) against 12-month persistent infection.
6-mjesečne perzistentne infekcije, odnosno 91,4% (96,1% CI: 89,4 ; 95,4) kod 12-mjesečne perzistentne infekcije.
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GSK Services Sp. z o.o. Tel.: + 48 (22) 576 9000
(3) mean follow-up of 44 months post dose 1
(3) prosječni period praćenja od 44 mjeseci nakon 1. doze
Vaccine efficacy against virological endpoints (6-month and 12-month persistent infection) associated with HPV-16/18 observed in TVC at end of study is presented in Table 4.
Djelotvornost cjepiva na virološke ishode (6-mjesečne i 12-mjesečne perzistentne infekcije) povezane sa HPV-16/18 uočene u TVC na kraju ispitivanja prikazana je u Tablici 4.
Vaccine efficacy against CIN1+ associated with HPV 16/18 observed in the ATP cohort was 91.7% (96.1% CI: 82.4;96.7).
Djelotvornost cjepiva protiv CIN1+ povezanim sa HPV 16/18, uočena u ATP kohorti, bila je 91,7% (96,1%-tni CI: 82,4;96,7).
Fever (≥38°C) Uncommon Other injection site reactions such as induration, local paraesthesia
manje često druge reakcije na mjestu injiciranja, poput otvrdnuća i lokalne parestezije
What Cervarix looks like and contents of the pack Suspension for injection.
Kako Cervarix izgleda i sadržaj pakiranja
Instructions for administration of the vaccine in pre-filled syringe
Upute za upotrebu cjepiva u napunjenoj štrcaljki
In clinical trials, more than 99% of initially seronegative subjects had seroconverted to both HPV types 16 and 18 one month after the third dose.
U kliničkim ispitivanjima je u više od 99% početno seronegativnih ispitanica, mjesec dana nakon treće doze cjepiva, došlo do serokonverzije i na HPV-16 i na HPV-18.
Table 1: Vaccine efficacy against high grade cervical lesions associated with HPV-16/18 (ATP cohort)
Tablica 1: Djelotvornost cjepiva na cervikalne lezije visokog stupnja povezane sa HPV-16/18 (ATP kohorta)
In a pooled analysis (HPV-029,-30 & -48), 99.7% and 100% of females aged 9 years seroconverted to HPV types 16 and 18, respectively after the third dose (at month 7) with GMTs at least 1.4-fold and 2.4-fold higher as compared to females aged 10-14 years and 15 to 25 years, respectively.
U udruženoj analizi (HPV-029, -30 i -48), u djevojčica u dobi od 9 godina došlo je od serokonverzije na HPV tip 16 u 99,7%, odnosno na HPV tip 18 u 100% djevojčica nakon treće doze (u mjesecu 7).
These can be recognised by: itchy rash of the hands and feet, swelling of the eyes and face, difficulty in breathing or swallowing, sudden drop in blood pressure and loss of consciousness.
oticanju očiju i lica, poteškoćama u disanju i gutanju,
At the end of study analysis, vaccine efficacy against CIN1 associated with HPV 16/18 observed in the ATP cohort was 92.8% (95% CI: 87.1;96.4).
U analizi na kraju ispitivanja, djelotvornost cjepiva na CIN1 povezanim sa HPV 16/18, uočena u ATP kohorti, bila je 92,8% (95% CI: 87,1: 96,4).
HPV-16 and HPV-18 are estimated to be responsible for approximately 70% of cervical cancers, 90% of anal cancers, 70% of HPV-related high grade vulvar and vaginal intraepithelial neoplasia and 78% of HPV related high-grade anal (AIN 2/3) intraepithelial neoplasia.
90% slučajeva karcinoma anusa, 70% vulvarnih i vaginalnih intraepitelnih neoplazija visokog stupnja povezanih s HPV-om te 78% analnih intraepitelnih neoplazija visokog stupnja (AIN 2/3) povezanih s HPV-om.
Table 2: Vaccine efficacy against virological endpoints associated with HPV-16/18 (ATP cohort) HPV-16/18 endpoint
Tablica 2: Djelotvornost cjepiva protiv viroloških ishoda povezanih s HPV-16/18 (ATP kohorta) HPV-16/18 ishod
Intramuscular use Shake before use
Za intramuskularnu primjenu Protresti prije primjene
Suspension for injection in pre-filled syringe
Suspenzija za injekciju u napunjenoj štrcaljki.
You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Nuspojave možete prijaviti izravno putem nacionalnog sustava za prijavu nuspojava: navedenog u Dodatku V*.
The second dose given between 5 and 13 months after the first dose
1 i 2,5 mjeseci nakon prve doze, a treća doza između 5 i 12 mjeseci nakon prve doze.
Prophylactic efficacy against HPV-16/18 in women naïve to HPV-16 and/or HPV-18
Djelotvornost profilakse protiv HPV-16/18 u žena bez prethodne infekcije s HPV-16 i/ili HPV-18
• fever (≥38°C)
crvenilo, oticanje, umor često vrućica (≥ 38°C)
Second injection: given between 5 and 13 months after first injection If you are 15 years old or above
Prva injekcija: odabranoga dana Druga injekcija: primjenjuje se između 5 i 13 mjeseci nakon prve injekcije
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PRE-FILLED SYRINGE LABEL
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA ZA NAPUNJENU ŠTRCALJKU
NAME OF THE MEDICINAL PRODUCT Cervarix suspension for injection in a vial
Cervarix suspenzija za injekciju u bočici
Itching/pruritus, rash, urticaria
Poremećaji kože i potkožnog tkiva često svrbež/pruritus, osip, urtikarija
9 to and including 14 years* Two doses each of 0.5 ml.
9 do uključivo 14 godina*
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.
U ispitivanje faze III (ispitivanje 008) uključene su žene bez prethodnog probira na prisutnost HPV
MARKETING AUTHORISATION NUMBER(S) EU/1/07/419/001 - pack of 1
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/07/419/001 - pakiranje od 1
Table 3: Vaccine efficacy against high grade cervical lesions associated with HPV-16/18 (TVC) HPV
Tablica 3: Djelotvornost cjepiva protiv cervikalnih lezija visokog stupnja povezanih sa HPV-16/18 (TVC)
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GlaxoSmithKline s.r.o. Tel: + 420 2 22 00 11 11 cz.info@gsk.com
Multidose vial EU/1/07/419/010 EU/1/07/419/011 EU/1/07/419/012
EU/1/07/419/010 EU/1/07/419/011 EU/1/07/419/012
Tel.: + 421 (0)2 48 26 11 11 recepcia.sk@gsk.com
Slovenská republika GlaxoSmithKline Slovakia s.r.o. Tel: + 421 (0)2 48 26 11 11 recepcia.sk@gsk.com
100 multidose vials 100 x 2 doses (1 ml)
100 višedoznih bočica 100 x 2 doze (1 ml)
Remove the needle protector, which on occasion can be a little stiff.
koji katkad može biti jače pričvršćen.
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GlaxoSmithKline d.o.o. Tel: + 386 (0) 1 280 25 00 medical.x.si@gsk.com
**If flexibility in the vaccination schedule is necessary, the second dose can be administered between 1 month and 2.5 months after the first dose and the third dose between 5 and 12 months after the first dose.
**Ako je potrebna fleksibilnost u rasporedu cijepljenja, druga se doza može primijeniti između
MARKETING AUTHORISATION NUMBER(S) EU/1/07/419/010 - pack of 1
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/07/419/010 - pakiranje od 1
No efficacy study against anal premalignant lesions has been conducted with Cervarix.
Nije provedeno ispitivanje djelotvornosti cjepiva Cervarix s obzirom na premaligne analne lezije.
Case counting for the TVC started on day 1 after the first dose.
je počelo prvog dana nakon prve primljene doze.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS MONODOSE VIAL LABEL
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA ZA JEDNODOZNU BOČICU
1 pre-filled syringe + 2 needles 1 dose (0.5 ml)
1 napunjena štrcaljka + 2 igle 1 doza (0,5 ml)
In study 007 the efficacy of Cervarix against 12-month persistent HPV-16/18 infection was 100% (95% CI: 80.5; 100).
U ispitivanju 007 djelotvornost cjepiva Cervarix protiv 12-mjesečne perzistentne infekcije HPV-16/18 iznosila je 100%
In another clinical trial (study 014) performed in women aged 15 to 55 years, all subjects seroconverted to both HPV types 16 and 18 after the third dose (at month 7).
U drugom kliničkom ispitivanju (ispitivanje 014), provedenom u žena u dobi od 15 do 55 godina, nakon treće doze cjepiva (u 7. mjesecu) sve su ispitanice imale serokonverziju na oba tipa HPV (HPV
Human Papillomavirus vaccine [Types 16, 18] (Recombinant, adjuvanted, adsorbed)
Cjepivo protiv humanog papilomavirusa [tipova 16, 18] (rekombinantno, adsorbirano, s adjuvansom)
HPV-31 6M PI HPV-45 6M PI HPV-31 ASC-US+ HPV-45 ASC-US+ N = number of subjects in each group n = number of subjects reporting at least one event in each group 6M PI = 6-month persistent infection CI = Confidence Interval ASC-US= Atypical Cells of Undetermined Significance (abnormal cytology) (1) 3 doses of vaccine, DNA negative and seronegative at month 0 (unless specified) and DNA negative at month 6 for the relevant HPV type (HPV-16 and/or HPV-18) (2) at least one dose of vaccine, irrespective of HPV DNA and serostatus (unless specified) at month 0.
Atypical Cells of Undetermined Significance) (abnormalan citološki nalaz) (1) 3 doze cjepiva, DNA negativne i seronegativne u nultom mjesecu (osim ako nije posebno navedeno) i DNA negativne u 6. mjesecu za relevantni tip HPV-a (HPV-16 i/ili HPV-18) (2) najmanje jedna doza cjepiva, bez obzira na status HPV DNA i serološki status (osim ako nije posebno navedeno) u nultom mjesecu.
N = number of subjects included in each group n = number of cases (1) ATP: includes women who received 3 doses of vaccine, were DNA negative and seronegative at month 0 and DNA negative at month 6 to the relevant HPV type (HPV
(1) ATP: uključuje žene koje su primile 3 doze cjepiva, bile DNA negativne u nultom mjesecu i 6. mjesecu na relevantne tipove HPV-a.
EU/1/07/419/011 - pack of 10
EU/1/07/419/011 - pakiranje od 10
EU/1/07/419/012 - pack of 100
EU/1/07/419/012 - pakiranje od 100
% Efficacy (96.2% CI)
Cervarix Kontrola % djelotvornosti (96,2% CI)
In two clinical trials (HPV-012 & -013) performed in girls aged 10 to 14 years, all subjects seroconverted to both HPV types 16 and 18 after the third dose (at month 7) with GMTs at least 2-fold higher as compared to women aged 15 to 25 years.
U dva klinička ispitivanja (HPV-012 i -013) provedena u djevojčica u dobi od 10 do 14 godina, u svih je ispitanica nakon treće doze cjepiva (u 7. mjesecu) došlo do serokonverzije i na HPV-16 i na HPV-18.
EU/1/07/419/003 - pack of 100
EU/1/07/419/003 - pakiranje od 100
♦ Very common (side effects which may occur in more than 1 per 10 doses of vaccine):
U kliničkim ispitivanjima s cjepivom Cervarix zabilježene su sljedeće nuspojave: ♦ Vrlo česte (nuspojave koje se mogu javiti kod više od 1 na 10 doza cjepiva):
HPV-16 related types (A9 species) HPV-31 HPV-33 HPV-35 HPV-52 HPV-58 HPV-18 related types (A7 species) HPV-39 HPV-45 HPV-59 HPV-68 Other types HPV-51 HPV-56 HPV-66 n= number of cases (1) ATP: includes women who received 3 doses of vaccine, were DNA negative at month 0 and at month 6 to the relevant HPV type.
HPV-31 6M PI HPV-45 6M PI HPV-31 ASC-US+ HPV-45 ASC-US+ N = broj ispitanica uključenih u pojedinu skupinu n = broj ispitanica u pojedinoj skupini koji su prijavili najmanje jedan događaj 6M PI =
1 pre-filled syringe + 1 needle 1 dose (0.5 ml)
1 napunjena štrcaljka + 1 igla 1 doza (0,5 ml)
DNA technology using a Baculovirus expression system which uses Hi-5 Rix4446 cells derived from the insect Trichoplusia ni. - The other ingredients are sodium chloride (NaCl), sodium dihydrogen phosphate dihydrate
DNA sustavom ekspresije bakulovirusa koji koristi Hi-5 Rix4446 stanice dobivene iz vrste Trichoplusia ni.
Since no vaccine is 100% effective and Cervarix will not provide protection against every HPV type, or against existing HPV infections, routine cervical screening remains critically important and should follow local recommendations.
učinkovito i Cervarix ne štiti od svakog HPV tipa, niti djeluje kod već postojećih HPV infekcija,
Very common Injection site reactions including pain, redness, swelling, fatigue
Opći poremećaji i reakcije na mjestu primjene vrlo često reakcije na mjestu injiciranja, uključujući bol,
10 pre-filled syringes 10 x 1 dose (0.5 ml)
10 napunjenih štrcaljki 10 x 1 doza (0,5 ml)
10 multidose vials 10 x 2 doses (1 ml)
10 višedoznih bočica 10 x 2 doze (1 ml)
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to medical prescription.
PRIMJENU C. OSTALI UVJETI I ZAHTJEVI ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET D. UVJETI ILI OGRANIČENJA VEZANI UZ SIGURNU I UČINKOVITU PRIMJENU LIJEKA
Vaccine-induced IgG GMTs for both HPV-16 and HPV-18 peaked at month 7 and then declined to reach a plateau from month 18 up to the [M107-M113] interval with ELISA GMTs for both HPV-16 and HPV-18 at least still 10-fold higher than the ELISA GMTs observed in women who cleared a natural HPV infection.
Tijekom razdoblja od 107. do 113. mjeseca, ELISA GMT-i oba tipa (HPV-16 i HPV-18) bili su najmanje 10 puta viši od titara u žena koje su imale prirodnu infekciju HPV, koja se povukla.
Cervarix may be administered concomitantly with a combined booster vaccine containing diphtheria (d), tetanus (T) and pertussis [acellular] (pa) with or without inactivated poliomyelitis (IPV), (dTpa, dTpa-IPV vaccines), with no clinically relevant interference with antibody response to any of the components of either vaccine.
Cervarix se može primijeniti istodobno uz kombinirano cjepivo za docjepljivanje protiv difterije (d), tetanusa (T), pertusisa [acelularnog] (pa), sa ili bez inaktiviranog poliomijelitisa (IPV), (cjepiva dTpa,
Posology
Bočica
2adsorbed on aluminium hydroxide, hydrated (Al(OH)3)
50 mikrograma 2 adsorbiran na aluminijev hidroksid, hidratizirani (Al(OH)3) ukupno 0,5 mg Al3+
10 pre-filled syringes + 20 needles 10 x 1 dose (0.5 ml)
10 napunjenih štrcaljki + 20 igala 10 x 1 doza (0,5 ml)
Musculoskeletal and connective tissue disorders
Poremećaji mišićno-koštanog sustava i vezivnog tkiva vrlo često mialgija često artralgija
100 vials 100 x 1 dose (0.5 ml)
100 x 1 doza (0,5 ml)
Very common Headache Uncommon Dizziness
Poremećaji živčanog sustava vrlo često glavobolja manje često omaglica
Luxembourg/Luxemburg GlaxoSmithKline Pharmaceuticals s.a./n.v.
Luxembourg/Luxemburg GlaxoSmithKline Pharmaceuticals s.a./n.v. Tél/Tel: + 32 10 85 52 00
If you get any side effects , talk to your doctor or pharmacist.
Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika ili ljekarnika.
Uncommon Upper respiratory tract infection
Infekcije i infestacije manje često infekcija gornjih dišnih putova
No minimal antibody level associated with protection against CIN of grade 2 or 3 or against persistent infection associated with vaccine HPV types has been identified for HPV vaccines.
Za HPV cjepiva nije određena minimalna razina protutijela povezanih sa zaštitom od CIN-a stupnja 2
How the vaccine is given
NAČIN PRIMJENE LIJEKA
Vial
Nuspojave
10 vials 10 x 1 dose (0.5 ml)
10 x 1 doza (0,5 ml)
10 pre-filled syringes + 10 needles 10 x 1 dose (0.5 ml)
10 napunjenih štrcaljki + 10 igala 10 x 1 doza (0,5 ml)