natgillin/translations-raw huggingface dataset:
Table 8: Percentage of 3-dose primed subjects with antibody concentrations ≥ 0.20 µg/ml one month post-primary and one month post-booster Antibody
Tablica 8: Postotak ispitanika primarno cijepljenih s 3 doze, s koncentracijom protutijela ≥ 0,20 µg/ml jedan mjesec nakon primarnog cijepljenja i jedan mjesec nakon doze docjepljivanja protutijelo
In COMPAS, serotypes 5 (2 cases), 18C (4 cases) and 23F (1 case) were detected in control group in addition to serotypes 6B and 14.
U ispitivanju COMPAS su uz serotipove 6B i 14 u kontrolnoj skupini pronađeni i serotipovi 5 (2 slučaja), 18C (4 slučaja) i 23F (1 slučaj).
4-dose vial
4-dozna bočica
1 adsorbed on aluminium phosphate
1 adsorbirani na aluminijev fosfat ukupno 0,5 miligrama
For the cross-reactive serotype 19A, the results did not suggest any differences in ELISA antibody GMCs and OPA GMTs between groups.
Za ukriženo reaktivni serotip 19A, rezultati nisu ukazali na razlike između skupina s obzirom na ELISA
Kawasaki disease
Krvožilni poremećaji vrlo rijetko Kawasakijeva bolest
92.7% of subjects achieved ELISA antibody concentrations ≥ 0.20 µg/ml and at least 81.7% achieved OPA titres ≥ 8 except serotype 1 (at least 58.8% with OPA titres ≥ 8).
Jedan mjesec nakon primarnog cijepljenja (tj. nakon treće doze), za svaki serotip sadržan u cjepivu najmanje 92,7% djece je postiglo ELISA koncentraciju protutijela ≥ 0,20 µg/ml, a najmanje 81,7% je postiglo OPA titre ≥ 8, osim za serotip 1 (najmanje 58,8% s OPA titrom ≥ 8).
2-dose vial
2-dozna bočica
The first dose may be given as early as 6 weeks of age with a second dose administered 2 months later.
Prva doza može se primijeniti već u dobi od navršenih 6 tjedana, a druga doza 2 mjeseca nakon prve doze.
0.5 milligram Al3+ in total 2 conjugated to protein D (derived from non-typeable Haemophilus influenzae) carrier protein
1 adsorbirani na aluminijev fosfat ukupno 0,5 miligrama Al3+ 2 konjugirani na protein D, proteinski nosač (dobiven iz netipiziranog Haemophilus influenzae)
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Synflorix injection
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Synflorix injekcija i.m.
• Synflorix is available in pre-filled syringes for 1 dose with or without needles in packs of 1, 10 or 50.
• Synflorix za 1 dozu je dostupan u pakiranju od 1, 10 ili 50 napunjenih štrcaljki sa ili bez igala.
If your child gets any side effects, talk to your doctor or pharmacist.
Ako Vaše dijete dobije bilo koju nuspojavu, potrebno je obavijestiti liječnika ili ljekarnika.
In a large-scale phase III/IV, double-blind, cluster-randomized, controlled, clinical trial in Finland (FinIP), children were randomised into 4 groups according to the two infant vaccination schedules [2-dose (3, 5 months of age) or 3-dose (3, 4, 5 months of age) primary schedule followed by a booster dose as of 11 months of age] to receive either Synflorix (2/3rd of clusters) or hepatitis vaccines as control (1/3rd of clusters).
U velikom dvostruko slijepom, klaster-randomiziranom, kontroliranom kliničkom ispitivanju faze III/IV provedenom u Finskoj (FinIP), djeca su bila randomizirana u 4 skupine prema dva rasporeda cijepljenja za dojenčad [primarna imunizacija s 2 doze (u 3. i 5. mjesecu života) ili 3 doze (u 3., 4. i 5. mjesecu života) te zatim doza docjepljivanja u dobi od 11 mjeseci ili više].
For most vaccine serotypes and serotype 19A, group comparisons did not suggest any differences post-booster dose in ELISA antibody GMCs and OPA GMTs between the HIV+/+ and HIV-/- groups, or the HIV+/- and HIV-/- groups.
Za većinu serotipova sadržanih u cjepivu, usporedbe nisu ukazale na razlike u imunološkom odgovoru nakon primarnog cijepljenja između skupina HIV+/+ i HIV-/- kao ni između skupina HIV+/- i HIV-/-,
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Synflorix suspension for injection
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Synflorix suspenzija za injekciju i.m.
A booster (fourth) dose is recommended at least 6 months after the last primary dose and may be given from the age of 9 months onwards (preferably between 12 and 15 months of age) (see sections 4.4 and 5.1).
Primjena doze docjepljivanja (četvrte doze) (docjepljivanje) preporučuje se najmanje 6 mjeseci nakon posljednje doze primarne imunizacije i može se primijeniti od navršenih 9 mjeseci nadalje (po mogućnosti u dobi između 12 i 15 mjeseci) (vidjeti dijelove 4.4 i 5.1).
Table 7: Percentage of 2-dose primed subjects with antibody concentrations ≥ 0.20 µg/ml one month post-primary and one month post-booster Antibody
Tablica 7: Postotak ispitanika primarno cijepljenih s 2 doze, s koncentracijom protutijela ≥ 0,20 µg/ml jedan mjesec nakon primarnog cijepljenja i jedan mjesec nakon doze docjepljivanja protutijelo
How to store Synflorix
Kako čuvati Synflorix
In children as of 2 years of age, fainting can occur following, or even before, any needle injection, therefore tell the doctor or nurse if your child fainted with a previous injection.
Kod djece od 2 godine može se dogoditi nesvjestica nakon, ili čak i prije bilo kojeg uboda s iglom.
Efficacy against any NTHi AOM episode was 35.3% (95% CI: 1.8; 57.4).
Djelotvornost protiv bilo koje epizode AOM-a uzrokovanog netipiziranim H. influenzae iznosila je 35,3% (95% CI: 1,8; 57,4).
Very common Fever ≥ 38 °C rectally (age < 2 years), pain, redness, swelling at the injection site.
Opći poremećaji i reakcije na mjestu primjene vrlo često vrućica ≥ 38°C rektalno (dob < 2 godine), bol, crvenilo, oticanje na mjestu injekcije često vrućica > 39°C rektalno (dob < 2 godine),
Whenever recommended, children at risk who are ≥ 24 months of age and already primed with Synflorix should receive 23-valent pneumococcal polysaccharide vaccine.
Kad god se to preporučuje, rizična djeca u dobi od ≥ 24 mjeseca koja su već primila primarni ciklus cjepiva
MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
PROIZVOĐAČI BIOLOŠKIH DJELATNIH TVARI I PROIZVOĐAČ
Control(2)
Prilagođena učinkovitost(2)
Children with sickle cell disease
Djeca s anemijom srpastih stanica
Synflorix suspension for injection in pre-filled syringe Synflorix suspension for injection Synflorix suspension for injection in multidose container (2 doses) Synflorix suspension for injection in multidose container (4 doses)
Synflorix suspenzija za injekciju u višedoznom spremniku (2 doze) Synflorix suspenzija za injekciju u višedoznom spremniku (4 doze)
For each of the seven serotypes in common, 87.7% to 100% of Synflorix vaccinees and 92.1% to 100% of 7-valent Prevenar vaccinees reached an OPA titre ≥ 8 one month after the third dose.
100% cijepljenih cjepivom Synflorix i 92,1% do 100% cijepljenih 7-valentnim cjepivom Prevenar postigli su OPA titar ≥8 jedan mjesec nakon treće doze.
Non-typeable Haemophilus influenzae (NTHi)
Netipizirani Haemophilus influenzae (NTHi) CI interval pouzdanosti (1) prva epizoda
Pneumococcal polysaccharide serotype 6B1,2
Pneumokokni polisaharid serotipa 6B1,2
Immunologic non-inferiority to 7-valent Prevenar
7-valentni Prevenar
Read the package leaflet before use Intramuscular use
Prije uporabe pročitajte uputu o lijeku.
• Synflorix is available in vials for 4 doses in packs of 10 or 100.
• Synflorix je dostupan u bočicama za 4 doze u pakiranju od 10 ili 100.
Very rare ( these may occur with up to 1 in 10,000 doses of the vaccine)
Vrlo rijetko (mogu se pojaviti u do 1 na 10 000 doza cjepiva)
EU/1/09/508/013 - pack of 100
EU/1/09/508/013 - pakiranje od 100
Immunogenicity following a fourth dose (booster dose) at 15 to 18 months of age was evaluated in 44 very preterm, 69 preterm and 127 full term infants.
15 do 18 mjeseci je procjenjivana u 44 znatno prijevremeno rođene dojenčadi, 69 dojenčadi rođene prije termina i 127 u terminu rođene dojenčadi.
10 pneumococcal vaccine serotypes
Bilo koji pneumokokni serotip 10 pneumokoknih serotipova zastupljenih u cjepivu
Pneumococcal polysaccharide serotype 19F1,4
Pneumokokni polisaharid serotipa 19F1,4
4-dose container Sodium chloride 2-phenoxyethanol Water for injections
4-dozni spremnik natrijev klorid 2-fenoksietanol voda za injekcije
Pneumococcal polysaccharide serotype 9V1,2
Pneumokokni polisaharid serotipa 9V1,2
A clinical study conducted in Burkina Faso assessed the immunogenicity of Synflorix administered to 146 children with SCD (haemoglobin SS disease, haemoglobin SC disease or with β-thalassemia) compared to 143 age-matched children without SCD.
Faso ocjenjivala se imunogenost cjepiva Synflorix primijenjenog u 146 djece s anemijom srpastih stanica (bolest hemoglobina SS, bolest hemoglobina
Very common (these may occur with more than 1 in 10 doses of the vaccine)
Vrlo često (mogu se pojaviti u više od 1 na 10 doza cjepiva)
In Finland, Synflorix was introduced into NIP with a 2+1 schedule in infants (3, 5 months of age and a booster dose at 12 months) without catch-up campaign.
Finskoj je Synflorix uveden u NPI s rasporedom cijepljenja 2+1 u dojenčadi (u dobi od 3, 5 mjeseci i doza docjepljivanja u 12 mjesecu) bez naknadne provedbe nakon propuštene ili odgođene imunizacije.
Post-marketing experience Immune system disorders
Iskustva nakon stavljanja u promet Poremećaji imunološkog sustava vrlo rijetko anafilaksija
Higher OPA GMTs in the group boosted at 15-18 months of age were observed for most of the vaccine serotypes and serotype 19A.
Opaženi su viši OPA GMT-i za većinu serotipova sadržanih u cjepivu kao i za serotip 19A
• Synflorix is available in vials for 1 dose in packs of 1, 10 or 100
• Synflorix za 1 dozu je dostupan u pakiranju od 1, 10 ili 100 bočica
After first opening of the 4-dose vial, the vaccine may be stored for a maximum of 28 days in a refrigerator (2°C - 8°C).
Nakon prvog otvaranja 4-dozne bočice, cjepivo treba čuvati u hladnjaku (2°C - 8°C), najduže 28 dana.
Non-inferiority was demonstrated as the upper limit of the 2-sided 95% CI of the antibody GMC ratios was below 2 for each of the 10 vaccine serotypes and for serotype 19A.
Ne-inferiornost pokazana kao gornja granica 2-stranog 95% CI omjera GMC protutijela bila je ispod 2
Pack size of 1, 10 or 100.
Veličina pakiranja: 10 ili 100.
Among the 15,447 children in the catch-up vaccinated cohorts, there were no culture-confirmed IPD cases in the Synflorix groups while 5 vaccine serotype IPD cases were observed in the control groups (serotypes 4, 6B, 7F, 14 and 19F).
U 15 447 djece u cijepljenim kohortama nakon naknadne provedbe cijepljenja nakon propuštene ili odgođene imunizacije, nije bilo kulturom potvrđenih slučajeva IPB-a u Synflorix grupi dok je u kontrolnim grupama zabilježeno 5 IPB slučajeva izazvanih serotipovima zastupljenim u cjepivu
Pack size of 10 or
Veličina pakiranja: 1,10 ili
A fine white deposit with a clear colourless supernatant may be observed upon storage of the pre-filled syringe.
Tijekom čuvanja napunjene štrcaljke može se uočiti fini bijeli talog s bistrim bezbojnim supernatantom.
Pneumococcal polysaccharide serotype 23F1,2
Pneumokokni polisaharid serotipa 23F1,2
MARKETING AUTHORISATION NUMBER(S) EU//1/09/508/009
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU//1/09/508/009
(5) in the ATP cohort VE was 100% (95% CI: 74.3; 100; 0 versus 16 cases)
(95% CI: 74,3; 100; 0 naspram 16 slučajeva)
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL MULTIDOSE (4 DOSES)
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NA VIŠEDOZNOJ BOČICI (4 DOZE)
IPD(1)
Tipovi IPB-a(1)
The mean duration follow-up from 2 weeks post-dose 3 in the ATP cohort was 23 months (range from 0 to 34 months) for the interim analysis (IA) and 30 months (range from 0 to 44 months) for the end-of-study analysis.
(raspon: 0 - 34 mjeseca) za međuanalizu te 30 mjeseci (raspon: 0 - 44 mjeseca) za analizu na kraju ispitivanja.
The clinical relevance of these differences is unclear, as Synflorix was observed to be effective against IPD caused by serotype 6B in a doubleblind, cluster-randomized clinical study (see Table 1).
Synflorix učinkovit protiv IPB-a uzrokovanog serotipom 6B (vidjeti Tablicu 1).
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PRE-FILLED SYRINGE LABEL
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NA NAPUNJENOJ ŠTRCALJKI
MARKETING AUTHORISATION NUMBER(S) EU/1/09/508/012 - pack of 10
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/09/508/012 - pakiranje od 10
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 4 doses (0.5 ml/dose)
SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 4 doze (0,5 ml/dozi)
• If your child gets any side effects, talk to your doctor or pharmacist.
• Ako Vaše dijete razvije bilo koju nuspojavu potrebno je obavijestiti liječnika ili ljekarnika.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL MULTIDOSE (2 DOSES)
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA NA VIŠEDOZNOJ BOČICI (2 DOZE)
LIST OF EXCIPIENTS Sodium chloride 2-phenoxyethanol Water for injections
natrijev klorid 2-fenoksietanol voda za injekcije
Instructions for administration of the vaccine presented in pre-filled syringe 1.
Upute za primjenu cjepiva u napunjenoj štrcaljki
What Synflorix is and what it is used for What you need to know before your child receives Synflorix How Synflorix is given
Što je Synflorix i za što se koristi Što morate znati prije nego
Pneumococcal polysaccharide serotype 7F1,2
Pneumokokni polisaharid serotipa 7F1,2
EU/1/09/508/008 - pack of 100
EU/1/09/508/008 - pakiranje od 100
asplenia, HIV infection, chronic illness, or those who have other immunocompromising conditions) placing them at higher risk for invasive disease due to Streptococcus pneumoniae.
asplenije, HIV infekcije, kronične bolesti ili drugih imunokompromitirajućih stanja).
Use with prophylactic administration of antipyretics
Primjena s antipireticima u profilaktičkoj primjeni
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 2 doses (0.5 ml/dose)
SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 2 doze (0,5 ml/dozi)
At the end-of-study analysis (ATP cohort), the vaccine efficacy (first episodes) against B-CAP was 18.2% (95% CI: 4.1; 30.3), against C-CAP 22.4% (95% CI: 5.7; 36.1) and against clinically suspected CAP referred for X-ray 7.3% (95% CI: 1.6; 12.6).
iznosila je 18,2% (95% CI: 4,1; 30,3), protiv C-CAP 22,4% (95% CI: 5,7; 36,1), a protiv klinički suspektnog CAP-a upućenog na rendgensko snimanje 7,3% (95% CI: 1,6; 12,6).
Anti-1 98.7 Anti-4 99.3 Anti-5 100
Anti-9V 99,3 Anti-14
0.5 ml of suspension in a vial (type I glass) for 1 dose with a stopper (butyl rubber).
0,5 ml suspenzije u bočici (staklo tip I) za 1 dozu s čepom (butil guma).
2 ml of suspension in a vial (type I glass) for 4 doses with a stopper (butyl rubber).
2 ml suspenzije u bočici (staklo tip I) za 4 doze s čepom (butil guma).
Impact on nasopharyngeal carriage (NPC)
Utjecaj na nazofaringealno kliconoštvo
Two-dose primary series
Primarna imunizacija s dvije doze
In comparative clinical studies, the incidence of local and general adverse events reported within 4 days after each vaccination dose was within the same range as after vaccination with 7-valent Prevenar.
4 dana nakon svake doze cijepljenja bila je u jednakom rasponu kao nakon cijepljenja 7-valentnim cjepivom Prevenar.
EU/1/09/508/007 - pack of 10
EU/1/09/508/007 - pakiranje od 10
The immune response to Synflorix for each of the vaccine serotypes and serotype 19A, as well as for protein D, did not appear to be influenced by SCD.
Čini se da anemija srpastih stanica nije utjecala na imunološki odgovor na Synflorix, tj. niti na jedan od serotipova sadržanih u cjepivu, serotip 19A kao ni na protein D.
Frequencies are reported as: Very common: (≥1/10) Common:
Učestalost nuspojava definirana je na sljedeći način: Vrlo često:
B-1330 Rixensart Belgium
BE-1330 Rixensart
• feeling sleepy
• osjećaj pospanosti
Pneumococcal polysaccharide serotype 11,2
Pneumokokni polisaharid serotipa 11,2
1 ml of suspension in a vial (type I glass) for 2 doses with a stopper (butyl rubber).
1 ml suspenzije u bočici (staklo tip I) za 2 doze s čepom (butil guma).
The reduction in B-CAP and C-CAP was greatest in children < 36 months of age (vaccine efficacy of 20.6% (95% CI: 6.5; 32.6) and 24.2% (95% CI: 7.4; 38.0) respectively).
< 36 mjeseci (djelotvornost cjepiva iznosila je 20,6% (95% CI: 6,5; 32,6) odnosno 24,2% (95% CI: 7,4; 38,0)).
PHARMACEUTICAL FORM AND CONTENTS Suspension for injection in multidose container (4 doses) 10 MULTIDOSE vials (4 doses per vial - 0.5 ml per dose) 100 MULTIDOSE vials (4 doses per vial - 0.5 ml per dose)
10 VIŠEDOZNIH bočica (4 doze po bočici - 0,5 ml po dozi) 100 VIŠEDOZNIH bočica (4 doze po bočici - 0,5 ml po dozi)
A clinical study conducted in South Africa assessed the immunogenicity of Synflorix after 3-dose (610-14 weeks of age) or 2-dose (6-14 weeks of age) priming followed by a booster dose at 9-10 months of age.
Synflorix nakon primarne imunizacije s 3 doze (u dobi od 6 - 10 - 14 tjedana) ili s 2 doze (u dobi od 6 - 14 tjedana) te doze docjepljivanja u dobi od 9 - 10 mjeseci.
Pneumococcal polysaccharide serotype 141,2
Pneumokokni polisaharid serotipa 141,2
In the study conducted in South Africa, the booster dose given at 9-10 months of age induced marked increases in antibody GMCs and OPA GMTs for each vaccine serotype and serotype 19A in both 2dose and 3-dose priming groups indicative of immunological priming.
9 - 10 mjeseci potaknula je značajno povećanje GMC-a protutijela i OPA GMT-a za svaki serotip sadržan u cjepivu kao i za serotip 19A i u skupini koja je primarno cijepljenja s 2 doze i u onoj cijepljenoj s 3 doze, što ukazuje na primarni imunološki odgovor.
Three-dose primary series
Primarna imunizacija s 3 doze
Pneumococcal polysaccharide serotype 51,2
Pneumokokni polisaharid serotipa 51,2
In clinical studies the immunogenicity of Synflorix was evaluated after a 2-dose primary vaccination series (470 subjects) according to different schedules (including 6-14 weeks, 2-4 or 3-5 months of age) and after a third (booster) dose (470 subjects) given at least 6 months after the last primary dose and from the age of 9 months onwards.
2 doze (u 470 ispitanika) prema različitim rasporedima (uključujući primjenu u dobi od 6 - 14 tjedana, 2 - 4 mjeseca ili 3 - 5 mjeseci) kao i nakon treće doze (docjepljivanja) (u 470 ispitanika) koja se davala najmanje 6 mjeseci nakon posljednje doze primarne imunizacije i od navršenih 9 mjeseci života nadalje.
MARKETING AUTHORISATION NUMBER(S) EU/1/09/508/006 - pack of 1
12. BROJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/09/508/006 - pakiranje od 1
3-dose primary schedule
neovisno o primarnom rasporedu cijepljenja.
OPA titre ≥ 8 for each vaccine serotype was comparable or higher in the catch-up group than in the 3dose primed infants.
Udio ispitanika s ELISA mjerenom koncentracijom protutijela ≥ 0,20 µg/ml ili OPA titrom ≥ 8 za svaki serotip iz cjepiva bio je usporediv ili viši u skupini koja se cijepila nakon naknadne provedbe nakon propuštene ili odgođene imunizacije nego u dojenčadi primarno cijepljenih s tri doze.
Serotype 6B IPD 0
IPB uzrokovan serotipom 6B IPB uzrokovan serotipom
The antibody GMCs and OPA GMTs were lower after 2-dose for most vaccine serotypes.
Za većinu serotipova sadržanih u cjepivu, GMC-i protutijela i OPA GMT-i bili su niži nakon rasporeda s 2 doze.
Pneumococcal polysaccharide conjugate vaccine (adsorbed)
Cjepivo protiv pneumokoka, polisaharidno, konjugirano, adsorbirano
Pneumococcal polysaccharide serotype 41,2
Pneumokokni polisaharid serotipa 41,2
In the nested Finnish study, a significant reduction was also observed for individual serotypes 14, 23F and, in the 3 dose primary schedule, for the cross-reactive serotype 19A.
U ugniježđenom finskom ispitivanju primijećeno je i značajno smanjenje pojedinačnih serotipova 14 i
Syringe cap
Klip štrcaljke
Preterm infants (born after 27 weeks and less than 37 weeks of pregnancy): Your child (from 2 months to 6 months of age) will receive 3 injections with an interval of at least one month between each dose.
Vaše dijete (u dobi od 2 mjeseca do 6 mjeseci) će primiti 3 injekcije u razmaku od najmanje jednog mjeseca između svake doze.
2100 Gödöllö
Homoki Nagy István utca 1. 2100 Gödöllö
In a clinical study NPC was assessed in HIV positive infants (N = 83) and HIV negative infants born from HIV positive mothers (N = 101) and compared to HIV negative infants born from HIV negative mothers (N = 100).
(N = 83) i HIV-negativne dojenčadi koju su rodile HIV-pozitivne majke (N = 101) u usporedbi s
In a large-scale phase III, randomized, double-blind clinical trial (Clinical Otitis Media and Pneumonia Study - COMPAS) conducted in Argentina, Panama and Colombia, healthy infants aged 6 to 16 weeks received either Synflorix or hepatitis B control vaccine at 2, 4 and 6 months of age followed respectively by either Synflorix or hepatitis A control vaccine at 15 to 18 months of age.
Synflorix ili cjepivo protiv hepatitisa B kao kontrolu u 2., 4. i 6. mjesecu života, nakon čega im je u dobi od 15 do 18 mjeseci primijenjen ili Synflorix ili cjepivo protiv hepatitisa A kao kontrola.
Rare (these may occur with up to 1 in 1,000 doses of the vaccine)
Rijetko (mogu se pojaviti u manje od 1 na 1000 doza cjepiva)
Check with your doctor or pharmacist before this vaccine is given if: • your child has a bleeding problem or bruises easily.
Provjerite s liječnikom ili ljekarnikom prije primjene ovog cjepiva:
The vaccine is for intramuscular use only.
Cjepivo je namijenjeno isključivo primjeni u mišić.
50 doses (0.5 ml)
50 napunjenih štrcaljki 50 doza (0,5 ml)
Store in the original package in order to protect from light Should be used within 6 hours after first broaching of the vial
Mora se upotrijebiti unutar 6 sati od prvog otvaranja bočice.
Package leaflet: Information for the user Synflorix suspension for injection in multidose container (4 doses) Pneumococcal polysaccharide conjugate vaccine (adsorbed)
Uputa o lijeku: Informacije za korisnika Synflorix suspenzija za injekciju u višedoznom spremniku (4 doze) Cjepivo protiv pneumokoka, polisaharidno, konjugirano, adsorbirano
Anaphylaxis
- kolapsu
The effect of Synflorix on nasopharyngeal carriage was studied in 2 double-blind randomised studies using an inactive control: in the nested study of FinIP in Finland (5,023 subjects) and in COMPAS (1,700 subjects).
FinIP u Finskoj (5023 ispitanika) te u ispitivanju COMPAS (1700 ispitanika).
CI Confidence Interval (1) First episode (2) Follow up period for a maximum of 40 months from 2 weeks after third primary dose (3) Not statistically significant by pre-defined criteria (One sided p=0.032).
(3) nije statistički značajno prema unaprijed definiranim kriterijima (jednostrana p-vrijednost = 0,032).
Anti-6B 63.1 Anti-7F 99.3 Anti-9V 99.3 Anti-14 100 Anti-18C 99.3 Anti-19F 96.1 Anti-23F 77.6
Anti-18C 99,3 Anti-19F 96,1 Anti-23F 77,6
Package leaflet: Information for the user Synflorix suspension for injection Pneumococcal polysaccharide conjugate vaccine (adsorbed)
Uputa o lijeku: Informacije za korisnika Synflorix suspenzija za injekciju Cjepivo protiv pneumokoka, polisaharidno, konjugirano, adsorbirano
Efficacy of Synflorix against first episodes of likely bacterial Community Acquired Pneumonia (CAP) occurring from 2 weeks after the administration of the 3rd dose was demonstrated in the ATP cohort
Community Acquired Pneumonia, CAP), koje su se počele javljati 2 tjedna nakon primjene 3. doze, dokazana je u međuanalizi ATP kohorte (p-vrijednost ≤ 0,002) (vođena događajima; primarni cilj).
Metabolism and nutrition disorders
Poremećaji metabolizma i prehrane vrlo često gubitak apetita
The primary infant series consists of three doses with the first dose given at 2 months of age and with an interval of at least 1 month between doses.
pri čemu se prva primjenjuje u dobi od 2 mjeseca, s razmakom od najmanje 1 mjeseca između pojedinih doza.
Store in the original package in order to protect from light After first use, the product may be stored in a refrigerator for a maximum of 28 days
Nakon prve primjene, cjepivo se može čuvati u hladnjaku najduže 28 dana.
Vaccine effectiveness was 6.1% (95% CI: -2.7; 14.1) for the 3+1 schedule and 7.4% (95% CI -2.8; 16.6) for 2+1 schedule for this AOM endpoint in the infant vaccinated cohort.
Učinkovitost cjepiva za navedenu mjeru ishoda za AOM u kohorti cijepljene dojenčadi iznosila je 6,1% (95% CI: -2,7; 14,1) za raspored 3+1 te
Pneumonia
LIJEKA