natgillin/translations-raw huggingface dataset:
HOW TO STORE PREPANDRIX
SHRANJEVANJE CEPIVA PREPANDRIX
Do not use the suspension and the emulsion after the expiry date which is stated on the carton.
27 Suspenzije in emulzije ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli.
28 After the vaccine is mixed:
Po premešanju cepiva:
What Prepandrix contains
Kaj vsebuje cepivo Prepandrix
Tél/Tel: + 32 2 656 21 11
28 Luxembourg/ Luxemburg België/ Belgique/ Belgien GlaxoSmithKline s. a. / n. v.
Latvija
29
30 GlaxoSmithKline Latvia SIA Tel: + 371 7312687 lv-epasts@gsk.com
Sverige GlaxoSmithKline AB Tel: + 46 (0) 8 638 93 00 info. produkt@ gsk. com
It is a suspension for injection that contains parts of the bacterium Streptococcus pneumoniae (S. pneumoniae).
Gre za suspenzijo za injiciranje, ki vsebuje dele bakterije Streptococcus pneumoniae (S. pneumoniae).
Prevenar is used to vaccinate infants and children aged between two months and five years against diseases caused by S. pneumoniae.
Zdravilo Prevenar se uporablja za cepljenje dojenčkov in otrok od drugega meseca do petega leta starosti proti boleznim, ki jih povzroča S. pneumoniae.
These include sepsis (blood infection), meningitis (infection of the membranes that surround the brain and spine), pneumonia (infection of the lungs), otitis media (infection of the middle ear) and bacteraemia (bacteria detected in the blood).
Te vključujejo sepso (okužbo krvi), meningitis (okužbo membran, ki obdajajo možgane in hrbtenjačo), pljučnico (okužbo pljuč), otitis medio (vnetje srednjega ušesa) in bakteriemijo (prisotnost bakterij v krvi).
The vaccination schedule to be used depends on the age of the child and should be based on official recommendations. • Infants aged between two and six months need three doses.
Shema cepljenja, ki se bo uporabila, je odvisna od starosti otroka in mora temeljiti na uradnih priporočilih. • Dojenčki, ki so stari od dva do šest mesecev, potrebujejo tri odmerke.
A fourth dose (booster) is recommended in the second year of life.
Četrti (poživilni) odmerek priporočamo v drugem letu življenja.
Alternatively, when Prevenar is given as part of a ‘ universal infant immunisation programme’ (when all infants in an area are vaccinated at around the same time), two doses can be given with an interval of at least two months, followed by a booster at 11 to 15 months of age. • Infants aged between seven and 11 months need two doses, with an interval of at least one month between doses.
Izjemoma, kadar se zdravilo Prevenar daje kot del „ splošnega imunizacijskega programa dojenčkov “ (kadar se vsi dojenčki na določenem območju cepijo ob približno istem času), se lahko dasta dva odmerka, med katerima mora biti vsaj dvomesečni presledek, sledi pa jima poživilni odmerek v 11. do 15. mesecu starosti; • Dojenčki, ki so stari od sedem do 11 mesecev, potrebujejo dva odmerka, med katerima mora biti vsaj enomesečni presledek.
A third dose is recommended in the second year of life. • Children aged between 12 and 23 months need two doses, with an interval of at least two months between doses. • Children aged between 24 months and five years need one single dose.
Tretji odmerek priporočamo v drugem letu življenja; • Otroci, ki so stari od 12 do 23 mesecev, potrebujejo dva odmerka, med katerima mora biti vsaj dvomesečni presledek; • Otroci, ki so stari od 24 mesecev do pet let, potrebujejo en sam odmerek.
The vaccine is given by injection into the thigh muscle in infants, or into the upper arm muscle in young children.
Cepivo se daje z injekcijo v stegensko mišico dojenčkov ali mišico nadlakti majhnih otrok.
When a person is given the vaccine, the immune system recognises the bacterium contained in the vaccine as ‘ foreign’ and makes antibodies against it.
Ko oseba prejme cepivo, imunski sistem prepozna bakterijo v cepivu kot „ tujek “
Reproduction is authorised provided the source is acknowledged. able to produce antibodies more quickly when it is exposed to the bacterium again.
Ko bo imunski sistem naslednjič izpostavljen bakteriji, bo lahko hitreje izdelal protitelesa.
Prevenar contains small amounts of polysaccharides (a type of sugar) extracted from the ‘ capsule ’ that surrounds the S. pneumoniae bacterium.
Zdravilo Prevenar vsebuje majhne količine polisaharidov (vrste sladkorja), pridobljenih iz „ ovojnice “, ki obdaja bakterijo S. pneumoniae.
These polysaccharides have been purified, then ‘ conjugated’ (attached) to a carrier to help them be better recognised by the immune system.
Ti polisaharidi se prečistijo, nato „ konjugirajo “ (vežejo) na nosilec, zaradi česar jih imunski sistem lahko bolje prepozna.
The vaccine is also ‘ adsorbed’ (fixed) onto an aluminium compound to stimulate a better response.
Cepivo je tudi „ adsorbirano “ (vezano) na površino aluminijeve spojine, kar spodbudi boljši odziv.
Prevenar contains the polysaccharides from different types of S. pneumoniae (serotypes 4, 6B, 9V, 14, 18C, 19F and 23F).
Zdravilo Prevenar vsebuje polisaharide iz različnih tipov S. pneumoniae (serotipi 4, 6B, 9V, 14, 18C, 19F in 23F).
In Europe, it is estimated that these are responsible for about 54% to 84% of invasive infections (infections that have spread into the body) in infants and children under the age of two years, and for about 62% to 83% of invasive infections in children aged between two and five years.
Po evropskih ocenah so ti serotipi odgovorni za približno 54% do 84% invazivnih okužb (okužb, ki so se razširile po telesu) dojenčkov in otrok, ki so mlajši od dveh let, in približno 62% do 83% invazivnih okužb otrok, ki so stari med dvema in pet let.
The effectiveness of Prevenar in the prevention of S. pneumoniae invasive disease has been studied in almost 38,000 infants.
Učinkovitost zdravila Prevenar pri preprečevanju invazivne bolezni, ki jih povzroča S. pneumoniae, so raziskali pri skoraj 38. 000 dojenčkih.
Half of the infants received Prevenar, and the remainder received another vaccine that is not active against S. pneumoniae.
Polovica dojenčkov je prejemala zdravilo Prevenar, preostali pa so prejemali cepivo, ki ni učinkovito proti S. pneumoniae.
Prevenar was given at two, four, six and 12 to 15 months of age.
Zdravilo Prevenar so dali v 2., 4., 6. in 12. – 15. mesecu starosti.
The study measured the number of children who developed an S. pneumoniae invasive disease during the 3.5 years of the study.
V študiji so preverjali število otrok, ki so v 3, 5- letnem obdobju te študije razvili invazivno bolezen zaradi S. pneumoniae.
Additional studies looked at the effectiveness and safety of Prevenar in older infants and children, and at the development of antibodies in infants after the two-dose immunisation schedule followed by a booster injection.
V dodatnih študijah so raziskovali učinkovitost in varnost zdravila Prevenar pri starejših dojenčkih in otrocih ter razvoj protiteles pri dojenčkih po imunizacijski shemi dveh odmerkov, ki jima je sledila poživilna injekcija.
Prevenar was effective in preventing S. pneumoniae invasive disease.
Zdravilo Prevenar je bilo učinkovito proti invazivni bolezni, ki jo povzroča S. pneumoniae.
During the main study, 49 cases of infection due to the serotypes 4, 6B, 9V, 14, 18C, 19F and 23F of S. pneumoniae were seen among the infants who received the control vaccine, compared with three cases among the infants vaccinated with Prevenar.
Med glavno študijo so pri dojenčkih, ki so prejeli kontrolno cepivo, odkrili 49 primerov okužbe zaradi serotipov S. pneumoniae 4, 6B, 9V, 14, 18C, 19F in 23F, medtem ko so pri dojenčkih, ki so jih cepili z zdravilom Prevenar, odkrili 3 primere okužb.
In infants, the two-dose immunisation schedule led to the development of antibodies against S. pneumoniae, but to a lower level than the three-dose schedule.
Pri dojenčkih je imunizacijska shema dveh odmerkov sicer povzročila razvoj protiteles proti S. pneumoniae, a v manjšem obsegu kot shema treh odmerkov.
However, the CHMP concluded that this is unlikely to lead to a difference in the rate of protection against infection with S. pneumoniae following a booster injection, when Prevenar is used as part of a routine immunisation programme in which most infants are vaccinated.
Vendar pa je CHMP odločil, da verjetno ne bo povzročilo razlike v stopnji zaščite proti okužbi s S. pneumoniae po poživilni injekciji, kadar se zdravilo Prevenar uporablja kot del rednega imunizacijskega programa, v katerem se večina otrok cepi.
The most common side effects with Prevenar (seen in more than 1 patient in 10) are vomiting, diarrhoea, loss of appetite, reactions at the site of the injection (redness, hardening, swelling or pain), fever, irritability, drowsiness and restless sleep.
Najpogostejši neželeni učinki zdravila Prevenar (opaženi pri več kot 1 od 10 bolnikov) so bruhanje, driska, izguba apetita, reakcije na mestu injiciranja (rdečina, zatrdlina, otekanje ali bolečina), povišana telesna temperatura, razdražljivost, zaspanost in nemiren spanec.
For the full list of all side effects reported with Prevenar, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Prevenar, glejte Navodilo za uporabo.
Prevenar should not be used in children who may be hypersensitive (allergic) to the Streptococcus vaccine, to any of the other ingredients or to the diphtheria toxoid (a weakened toxin from the bacterium that causes diphtheria).
Zdravila Prevenar ne smejo uporabljati otroci, ki utegnejo biti preobčutljivi za (alergični na) cepivo Streptococcus, katero od drugih pomožnih sestavin zdravila ali davični toksoid (oslabljeni toksin iz bakterije, ki povzroča davico).
As for all vaccines, if Prevenar is used in very premature babies, there is a risk of the babies experiencing apnoea (brief pauses in breathing).
Kot velja pri vseh cepivih, če se zdravilo Prevenar uporablja pri nedonošenčkih, obstaja nevarnost, da doživijo apnejo (krajšo odsotnost dihanja).
The Committee for Medicinal Products for Human Use (CHMP) decided that Prevenar’ s benefits are greater than its risks for active immunisation against disease caused by S. pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F and 23F (including sepsis, meningitis, pneumonia, bacteraemia and acute otitis media) in infants and children from two months up to five years of age.
Odbor za zdravila za uporabo v humani medicini (CHMP) je odločil, da so koristi zdravila pri aktivni imunizaciji proti bolezni, ki jo povzročajo serotipi S. pneumoniae 4, 6B, 9V, 14, 18C, 19F in 23F (vključno s sepso, meningitisom, pljučnico, bakteremijo in akutnim vnetjem srednjega ušesa) pri dojenčkih in otrocih od drugega meseca do petega leta starosti, večje od z njim povezanih tveganj.
The Committee recommended that Prevenar be given marketing authorisation.
Odbor je priporočil odobritev dovoljenja za promet z zdravilom Prevenar.
Other information about Prevenar:
Druge informacije o zdravilu Prevenar:
The European Commission granted a marketing authorisation valid throughout the European Union for Prevenar to Wyeth Lederle Vaccines S. A. on 2 February 2001.
Evropska komisija je dovoljenje za promet z zdravilom Prevenar, veljavno po vsej Evropski uniji, odobrila družbi Wyeth Lederle Vaccines S. A. dne 2. februarja 2001.
The marketing authorisation was renewed on 2 February 2006.
Dovoljenje za promet z zdravilom je bilo podaljšano dne 2. februarja 2006.
2/ 3 The full EPAR for Prevenar is available here.
2/ 3 Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Prevenar je na voljo tukaj.
Prevenar – Pharmaceutical Form(s) and Strength(s)
Prevenar – farmacevtska / - e oblika / - e in jakost / - i Številka EU
Route of Administration
farmacevtska oblika pot uporabe
EU/ 1/ 00/ 167/ 001
-- 1 EU/ 1/ 00/ 167/ 001
pre-filled syringe (glass)
napolnjena steklena injekcijska brizga
EU/ 1/ 00/ 167/ 008
EU/ 1/ 00/ 167/ 008 1
5 x 10 pre-filled syringes
5 x 10 napolnjenih injekcijskih brizg
* A monodose preparation of 0.5 ml contains:
* Vsak odmerek po 0, 5 ml vsebuje:
Serotype 4 Serotype 9V Serotype 14 Serotype 18C Serotype 19F Serotype 23F Serotype 6B
Pnevmokokni polisaharid serotip 4 * Pnevmokokni polisaharid serotip 9V * Pnevmokokni polisaharid serotip 14 * Pnevmokokni oligosaharid serotip 18C * Pnevmokokni polisaharid serotip 19F * Pnevmokokni polisaharid serotip 23F * Pnevmokokni polisaharid serotip 6B *
2 µg 2 µg 2 µg 2 µg 2 µg 2 µg
2 µg 2 µg 2 µg 2 µg 2 µg 2 µg 4 µg
Conjugated to CRM197 carrier protein
* konjugiran (vezan) na CRM197 nosilni protein
~ 20 µg
~20µg
Pneumococcal polysaccharide serotype 4* Pneumococcal polysaccharide serotype 6B* Pneumococcal polysaccharide serotype 9V* Pneumococcal polysaccharide serotype 14* Pneumococcal oligosaccharide serotype 18C* Pneumococcal polysaccharide serotype 19F* Pneumococcal polysaccharide serotype 23F*
Vsak odmerek po 0, 5 ml vsebuje: pnevmokokni polisaharid serotip 4 * pnevmokokni polisaharid serotip 6B * pnevmokokni polisaharid serotip 9V * pnevmokokni polisaharid serotip 14 * pnevmokokni oligosaharid serotip 18C * pnevmokokni polisaharid serotip 19F * pnevmokokni polisaharid serotip 23F *
2 micrograms 4 micrograms 2 micrograms 2 micrograms 2 micrograms 2 micrograms 2 micrograms
2 mikrograma 4 mikrograme 2 mikrograma 2 mikrograma 2 mikrograma 2 mikrograma 2 mikrograma
* Conjugated to the CRM197 carrier protein and adsorbed on aluminium phosphate (0.5 mg)
* vezan na CRM197 nosilni protein in adsorbiran na aluminijev fosfat (0, 5 mg)
For the number of doses to be administered in the different age groups, see section 4.2.
4. 1 Terapevtske indikacije
The use of Prevenar should be determined on the basis of official recommendations taking into consideration the impact of invasive disease in different age groups as well as variability of serotype epidemiology in different geographical areas (see sections 4.4, 4.8 and 5.1).
Aktivna imunizacija proti boleznim, ki jih povzroča Streptococcus pneumoniae serotipov 4, 6B, 9V, 14, 18C, 19F in 23F (vključno s sepso, meningitisom, pljučnico, bakteriemijo in akutnim vnetjem srednjega ušesa) pri dojenčkih in otrocih od 2. meseca do 5. leta starosti (glejte poglavja 4. 2, 4. 4 in 5. 1).
4.2 Posology and method of administration
Glede števila odmerkov, ki so potrebni v različnih starostnih skupinah, glejte poglavje 4. 2.
The preferred sites are anterolateral aspect of the thigh (vastus lateralis muscle) in infants or the deltoid muscle of the upper arm in young children.
Najprimernejše mesto injiciranja je anterolateralni del stegna (mišica vastus lateralis) pri dojenčkih ali deltoidna mišica na nadlahti pri malih otrocih.
Immunisation schedules:
Imunizacijske sheme:
2 Infants aged 2 - 6 months:
Dojenčki od 2. do 6. meseca starosti:
The primary infant series consists of three doses, each of 0.5 ml, the first dose usually given at 2 months of age and with an interval of at least 1 month between doses.
Primarno zaporedje za dojenčke sestavljajo trije odmerki po 0, 5 ml; prvi odmerek običajno pri 2 mesecih, med ostalima odmerkoma mora biti najmanj enomesečni presledek.
Alternatively, when Prevenar is given as part of a routine infant immunisation programme, a two-dose schedule may be considered.
2 Kadar se cepivo Prevenar daje v okviru rutinskega programa cepljenja dojenčkov, lahko pride v poštev tudi shema z dvema odmerkoma.
The first dose may be given from the age of 2 months with a second dose at least 2 months later and a third (booster) dose at 11-15 months of age (see section 5.1)
Prvi odmerek se lahko da od starosti 2 mesecev naprej, drugega vsaj 2 meseca pozneje, tretji (poživitveni) odmerek pa v starosti 11- 15 mesecev (glejte poglavje 5. 1).
Infants aged 7 - 11 months: two doses, each of 0.5 ml, with an interval of at least 1 month between doses.
Dojenčki, stari od 7 do 11 mesecev: dva odmerka po 0, 5 ml; med obema odmerkoma mora biti vsaj enomesečni presledek.
Children aged 12 - 23 months: two doses, each of 0.5 ml, with an interval of at least 2 months between doses.
Mali otroci, stari od 12 do 23 mesecev: dva odmerka po 0, 5 ml; med obema odmerkoma mora biti vsaj dvomesečni interval.
Hypersensitivity to the active substances or to any of the excipients, or to diphtheria toxoid.
Preobčutljivost za zdravilne učinkovine, katerokoli pomožno snov cepiva ali za davični toksoid.
As with other vaccines, the administration of Prevenar should be postponed in subjects suffering from acute moderate or severe febrile illness.
Kot pri drugih cepljenjih je treba tudi cepljenje s cepivom Prevenar odložiti pri otrocih, ki imajo akutno zmerno ali hudo vročinsko bolezen.
The potential risk of apnoea and the need for respiratory monitoring for 48-72h should be considered when administering the primary immunisation series to very premature infants (born ≤ 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity.
Pri dajanju odmerkov primarne imunizacije veliko prezgodaj rojenim nedonošenčkom (rojenim pred ali v 28. tednu nosečnosti), še posebno tistim z respiratorno nezrelostjo v anamnezi, je treba upoštevati možnost pojava apneje in potrebo po 48- urnem do 72- urnem spremljanju pljučnega delovanja.
A higher rate of local reactions has been observed in children older than 24 months of age compared with infants (see section 4.8).
Pri otrocih, starejših od 24 mesecev, so opažali večjo pogostnost lokalnih reakcij kot pri dojenčkih (glejte poglavje 4. 8).
3 Limited data have demonstrated that Prevenar (three dose primary series) induces an acceptable immune response in infants with sickle cell disease with a safety profile similar to that observed in non-high-risk groups (see section 5.1).
Obstaja nekaj podatkov, ki so pokazali, da Prevenar (primarno zaporedje treh odmerkov) pri dojenčkih z anemijo srpastih celic sproži sprejemljiv imunski odziv s podobnim varnostnim profilom kot pri skupinah, pri katerih tveganje ni veliko (glejte poglavje 5. 1).
Safety and immunogenicity data are not yet available for children in other specific high-risk groups for invasive pneumococcal disease (e. g. children with another congenital or acquired splenic dysfunction, HIV-infected, malignancy, nephrotic syndrome).
Podatki o imunogenosti in varnosti cepiva pri otrocih z visokim specifičnim tveganjem za invazivne pnevmokokne okužbe še niso na voljo (npr. otroci z drugo prirojeno ali pridobljeno motnjo delovanja vranice, z okužbo s HIV, z malignimi boleznimi, nefrotskim sindromom).
Children below 2 years old should receive the appropriate-for-age Prevenar vaccination series (see section 4.2).
Pri otrocih, mlajših od 2 let, je treba uporabiti starosti primerno zaporedje cepljenj s cepivom Prevenar (glejte poglavje 4. 2).
The use of pneumococcal conjugate vaccine does not replace the use of 23-valent pneumococcal polysaccharide vaccines in children ≥ 24 months of age with conditions (such as sickle cell disease, asplenia, HIV infection, chronic illness or who are immunocompromised) placing them at higher risk for invasive disease due to Streptococcus pneumoniae.
3 valentnega polisaharidnega cepiva proti pnevmokokom pri otrocih, starih ≥ 24 mesecev s povečanim tveganjem (anemija srpastih celic, asplenija, okužba s HIV, kronične bolezni, imunska kompromitiranost) za invazivno okužbo, povzročeno z bakterijo Streptococcus pneumoniae.
Whenever recommended, children at risk who are ≥ 24 months of age and already primed with Prevenar should receive 23-valent pneumococcal polysaccharide vaccine.
Otroci s povečanim tveganjem, stari ≥ 24 mesecev, morajo dobiti 23- valentno pnevmokokno polisaharidno cepivo, kadarkoli je to potrebno, tudi če so bili cepljeni s cepivom Prevenar.
The interval between the pneumococcal conjugate vaccine (Prevenar) and the 23- valent pneumococcal polysaccharide vaccine should not be less than 8 weeks.
Presledek med konjugiranim pnevmokoknim cepivom (Prevenar) in 23- valentnim pnevmokoknim polisaharidnim cepivom naj bo najmanj 8 tednov.
There are no data available to indicate whether the administration of 23-valent pneumococcal polysaccharide vaccine to unprimed children or to children primed with Prevenar might result in hyporesponsiveness to further doses of Prevenar.
Ni podatkov, ki bi kazali, ali uporaba 23- valentnega pnevmokoknega polisaharidnega cepiva pri otrocih, ki še niso bili cepljeni, ali pri otrocih, že cepljenih s cepivom Prevenar, lahko povzroči zmanjšano odzivnost na nadaljnje odmerke cepiva Prevenar.
When Prevenar is co-administered with hexavalent vaccines (DTaP/ Hib(PRP-T)/ IPV/ HepB), the physician should be aware that data from clinical studies indicate that the rate of febrile reactions was higher compared to that occurring following the administration of hexavalent vaccines alone.
Če zdravnik kombinira cepivo Prevenar s šestvalentnim cepivom (DTaP/ Hib( PRP- T) IPV/ HepB), mora upoštevati, da se po podatkih iz kliničnih študij po kombiniranem cepljenju pogosteje pojavljajo vročinske reakcije kot po samem šestvalentnem cepivu.
These reactions were mostly moderate (less than or equal to 39 °C) and transient (see section 4.8).
Te reakcije so večinoma zmerne (39 °C ali manj) in prehodne (glejte poglavje 4. 8).
Prophylactic antipyretic medication is recommended:
Profilaktično dajanje zdravil proti zvišani telesni temperaturi je priporočljivo:
- for all children receiving Prevenar simultaneously with vaccines containing whole cell pertussis
- pri vseh otrocih, ki so prejeli Prevenar in so bili istočasno cepljeni tudi s cepivom proti
because of higher rate of febrile reactions (see section 4.8).
oslovskemu kašlju, ki vsebuje celotne celice, zaradi pogostih vročinskih reakcij (glejte poglavje 4. 8).
As otitis media is caused by many organisms other than pneumococcal serotypes represented in the vaccine, protection against all otitis media is expected to be low (see section 5.1).
Ker vnetje srednjega ušesa povzročajo poleg pnevmokoknih serotipov, zastopanih v cepivu, še številni drugi mikroorganizmi, pričakujemo, da bo zaščita pred vnetjem srednjega ušesa glede na vse povzročitelje majhna (glejte poglavje 5. 1).
The antibody response to Hib tetanus protein conjugate (PRP-T), tetanus and Hepatitis B (HepB) vaccines was similar to controls.
Porast protiteles po cepljenju s konjugiranim cepivom proti bakteriji Haemophilus influenzae tipa B (Hib), vezanim na tetanusni protein (PRP- T), cepivom proti tetanusu in cepivom proti hepatitisu B (HepB) je bil podoben kot v kontrolnih skupinah.
For CRM-based Hib conjugate vaccine, enhancement of antibody responses to Hib and diphtheria in the infant series was observed.
Po uporabi konjugiranega cepiva Hib- CRM so pri dojenčkih opazili povečano tvorbo protiteles proti bakteriji Hib in davici.
4 Data on concomitant administration of Prevenar with Infanrix hexa (DTaP/ Hib(PRP-T)/ IPV/ HepB vaccine) have shown no clinically relevant interference in the antibody response to each of the individual antigens when given as a 3 dose primary vaccination.
Podatki o sočasni uporabi cepiva Infanrix hexa (DTaP/ Hib( PRP- T) / IPV/ HepB) s cepivom Prevenar kažejo, da ne pride do klinično pomembnih sprememb v tvorbi protiteles proti posameznim antigenom, če ga uporabimo kot osnovno cepljenje s tremi odmerki.
In a clinical trial that compared separate with concomitant administrations of Prevenar (three doses at 2, 3.5, 6 months and a booster dose at approximately 12 months) and Meningitec (meningococcal C conjugate vaccine; two doses at 2 and 6 months and a booster dose at approximately 12 months) there was no evidence of immune interference between the two conjugate vaccines after the primary series or after the booster doses.
V kliničnem preskušanju, ki je primerjalo samostojno uporabo cepiva Prevenar (trije odmerki pri 2, 3, 5 in 6 mesecih ter poživitveni odmerek pri približno 12 mesecih starosti) in sočasno uporabo tega cepiva s cepivom Meningitec (konjugirano meningokokno C cepivo; 2 odmerka pri 2 in 6 mesecih in
Information on the safety of the vaccine when used during pregnancy and lactation is not available.
Podatkov o varnosti uporabe cepiva med nosečnostjo in dojenjem ni.
The safety of the vaccine was assessed in different controlled clinical studies in which more than 18,000 healthy infants (6 weeks to 18 months) were included.
Podatki o varnosti cepiva izhajajo iz različnih kontroliranih kliničnih študij, v katere je bilo vključenih več kot 18. 000 zdravih otrok (starih 6 tednov do 18 mesecev).