Právní předpis byl sestaven k datu 08.02.2024.
Zobrazené znění právního předpisu je účinné od 08.02.2024.
Sdělení Ministerstva zdravotnictví o antigenním složení očkovacích látek proti pneumokokovým infekcím pro očkování v dětském věku a u pojištěnců s rizikovými faktory zdravotního stavu
23/2024 Sb.
23
SDĚLENÍ
Ministerstva xxxxxxxxxxxxx
xx xxx 29. xxxxx 2024
x xxxxxxxxxx složení xxxxxxxxxx xxxxx xxxxx xxxxxxxxxxxxx xxxxxxxx xxx xxxxxxxx x xxxxxxx věku x x pojištěnců x xxxxxxxxxx faktory xxxxxxxxxxx xxxxx
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Xxxxxxxxxxxx zdravotnictví xxxxx §30 xxxx. 2 písm. x) x k) xxxxxx x. 48/1997 Xx., x xxxxxxxx xxxxxxxxxx xxxxxxxxx a o xxxxx a xxxxxxxx xxxxxxxxx souvisejících xxxxxx, xx xxxxx xxxxxxxxxx xxxxxxxx, xxxxxxx xxxxxxxxx xxxxxxx očkovacích xxxxx xxx xxxxxxxx xxxxx xxxxxxxxxxxxx xxxxxxxx v xxxxxxx xxxx a x xxxxxxxxxx x xxxxxxxxxx xxxxxxx zdravotního xxxxx:
1)&xxxx;13xxxxxxxx xxxxxxxxxxxxxxxx xxxxxxxxxxxx xxxxxxxx látku xxxxx xxxxxxxxxxxxx xxxxxxxx, xxxxx x xxxxx xxxxx (0,5 xx) obsahuje:
Streptococci xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 11&xxxx;2,2 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 31&xxxx;2,2 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum xxxxxxxxx 41&xxxx;2,2 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 51&xxxx;2,2 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 6A1 2,2 xxxxxxxxxx
Xxxxxxxxxxxx pneumoniae polysaccharidum xxxxxxxxx 6X1&xxxx;4,4 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 7X1&xxxx;2,2 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 9X1&xxxx;2,2 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum xxxxxxxxx 141 2,2 mikrogramů
Streptococci xxxxxxxxxx polysaccharidum xxxxxxxxx 18X1&xxxx;2,2 mikrogramů
Streptococci xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 19A1 2,2 xxxxxxxxxx
Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 19X1&xxxx;2,2 mikrogramů
Streptococci xxxxxxxxxx polysaccharidum xxxxxxxxx 23X1&xxxx;2,2 xxxxxxxxxx
1 Xxxxxxxxxx x xxxxxx xxxxxxxxx XXX197 x xxxxxxxxxx xx xxxxxxxxxxx xxxxxxx.
XXXX
2)&xxxx;15xxxxxxxx xxxxxxxxxxxxxxxx xxxxxxxxxxxx xxxxxxxx xxxxx proti pneumokokovým xxxxxxxx, xxxxx x xxxxx xxxxx (0,5 xx) xxxxxxxx:
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 11,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 31,2&xxxx;xxxxxxxxxxxxxxx 2,0 mikrogramů
Streptococci xxxxxxxxxx xxxxxxxx 41,2&xxxx;xxxxxxxxxxxxxxx 2,0 mikrogramů
Streptococci pneumoniae xxxxxxxx 51,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 6X1,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 6X1,2&xxxx;xxxxxxxxxxxxxxx 4,0 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 7X1,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx
Xxxxxxxxxxxx pneumoniae xxxxxxxx 9X1,2&xxxx;xxxxxxxxxxxxxxx 2,0 mikrogramů
Streptococci xxxxxxxxxx serotypi 141,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx
Xxxxxxxxxxxx pneumoniae xxxxxxxx 18X1,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx
Xxxxxxxxxxxx pneumoniae serotypi 19X1,2&xxxx;xxxxxxxxxxxxxxx 2,0 mikrogramů
Streptococci xxxxxxxxxx serotypu 19F1,2 polysaccharidum 2,0 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 22F1,2 polysaccharidum 2,0 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 23X1,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx serotypi 33X1,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx
1 Xxxxxxxxxx x xxxxxxxxxxx xxxxxxx XXX197. XXX197&xxxx;xx xxxxxxxxx xxxxxx xxxxxxxxxxxx xxxxxx (xxxxxxxxxxxxx z Xxxxxxxxxxxxxxx xxxxxxxxxxx X7) rekombinantně xxxxxxxxxxxxx v Xxxxxxxxxxx xxxxxxxxxxx.
2 Xxxxxxxxxx na xxxxxxxx xxxxxxxxxxx hlinitý.
NEBO
3) očkovací xxxxx xxxxx pneumokokovým xxxxxxxx používané v xxxxxxxxxx xxxxxxxx:
3x)&xxxx;13xxxxxxxx xxxxxxxxxxxxxxxx xxxxxxxxxxxx xxxxxxxx xxxxx xxxxx xxxxxxxxxxxxx xxxxxxxx, xxxxx x xxxxx xxxxx (0,5 ml) xxxxxxxx:
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 11&xxxx;2,2 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 31&xxxx;2,2 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 41&xxxx;2,2 xxxxxxxxxx
Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 51 2,2 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum sérotypus 6X1&xxxx;2,2 xxxxxxxxxx
Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx sérotypus 6B1 4,4 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 7X1&xxxx;2,2 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 9X1&xxxx;2,2 xxxxxxxxxx
Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 141&xxxx;2,2 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 18X1&xxxx;2,2 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 19X1&xxxx;2,2 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 19X1&xxxx;2,2 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 23X1&xxxx;2,2 xxxxxxxxxx
1 Xxxxxxxxxx x nosným xxxxxxxxx CRM197 a xxxxxxxxxx xx fosforečnan xxxxxxx.
X
3x)&xxxx;23xxxxxxxx xxxxxxxxxxxxxxxx očkovací látku xxxxx xxxxxxxxxxxxx xxxxxxxx, xxxxx x xxxxx xxxxx (0,5 ml) xxxxxxxx:
xx 25 mikrogramech xxxxxxxxxxxxx 23 xxxxxxxxxxxxxx xxxxxxxxxxxxxxxxx sérotypů: 1, 2, 3, 4, 5, 6X, 7F, 8, 9X, 9V, 10X, XX, 12X, 14, 15B, 17X, 18X, 19X, 19X, 20, 22X, 23X, 33X
XXXX
4)&xxxx;xxxxxxxx látky proti xxxxxxxxxxxxx infekcím používané x sekvenčním schématu:
4a) 15valentní xxxxxxxxxxxxxxxx xxxxxxxxxxxx očkovací xxxxx xxxxx xxxxxxxxxxxxx xxxxxxxx, xxxxx x xxxxx xxxxx (0,5 xx) obsahuje:
Streptococci pneumoniae xxxxxxxx 11,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx
Xxxxxxxxxxxx pneumoniae xxxxxxxx 31,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx serotypi 41,2&xxxx;xxxxxxxxxxxxxxx 2,0 mikrogramů
Streptococci xxxxxxxxxx xxxxxxxx 51,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 6X1,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx serotypi 6X1,2&xxxx;xxxxxxxxxxxxxxx 4,0 xxxxxxxxxx
Xxxxxxxxxxxx pneumoniae xxxxxxxx 7F1,2 polysaccharidum 2,0 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 9X1,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 141,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 18C1,2 polysaccharidum 2,0 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx serotypi 19X1,2&xxxx;xxxxxxxxxxxxxxx 2,0 mikrogramů
Streptococci xxxxxxxxxx xxxxxxxx 19X1,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 22F1,2 polysaccharidum 2,0 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx serotypi 23X1,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx serotypi 33F1,2 polysaccharidum 2,0 xxxxxxxxxx
1 Xxxxxxxxxx x xxxxxxxxxxx xxxxxxx XXX197. XXX197&xxxx;xx netoxická xxxxxx xxxxxxxxxxxx toxinu (xxxxxxxxxxxxx z Xxxxxxxxxxxxxxx xxxxxxxxxxx X7) xxxxxxxxxxxxx xxxxxxxxxxxxx x Xxxxxxxxxxx xxxxxxxxxxx.
2 Adsorbován na xxxxxxxx fosforečnan xxxxxxx.
X
4x)&xxxx;23xxxxxxxx xxxxxxxxxxxxxxxx xxxxxxxx xxxxx xxxxx pneumokokovým xxxxxxxx, xxxxx v xxxxx xxxxx (0,5 ml) xxxxxxxx:
xx 25 xxxxxxxxxxxx xxxxxxxxxxxxx 23 pneumokokových xxxxxxxxxxxxxxxxx xxxxxxxx: 1, 2, 3, 4, 5, 6X, 7X, 8, 9X, 9X, 10X, HA, 12X, 14, 15B, 17X, 18X, 19X, 19A, 20, 22X, 23X, 33X
XXXX
5)&xxxx;20xxxxxxxx xxxxxxxxxxxxxxxx xxxxxxxxxxxx xxxxxxxx látku xxxxx xxxxxxxxxxxxx infekcím, xxxxx x xxxxx xxxxx (0,5 ml) xxxxxxxx:
Xxxxxxxxxxxx xxxxxxxx (pneumokoka) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 11,2 2,2 xxxxxxxxxx
xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx pneumoniae sérotypů 31,2&xxxx;2,2 xxxxxxxxxx
xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 41,2&xxxx;2,2 xxxxxxxxxx
xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Streptococcus xxxxxxxxxx xxxxxxxx 51,2&xxxx;2,2 xxxxxxxxxx
xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 6X1,2&xxxx;2,2 xxxxxxxxxx
xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx pneumoniae xxxxxxxx 6X1,2&xxxx;4,4 xxxxxxxxxx
xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 7X1,2&xxxx;2,2 xxxxxxxxxx
xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx sérotypů 81,2&xxxx;2,2 xxxxxxxxxx
xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 9V1,2 2,2 mikrogramů
polysacharid xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx sérotypu 10X1,2&xxxx;2,2 xxxxxxxxxx
xxxxxxxxxxxx xxxxxxxx (pneumokoka) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 11 A1,2 2,2 xxxxxxxxxx
xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Streptococcus xxxxxxxxxx xxxxxxxx 12X1,2&xxxx;2,2 xxxxxxxxxx
xxxxxxxxxxxx xxxxxxxx (pneumokoka) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 141,2&xxxx;2,2 xxxxxxxxxx
xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 15X1,2&xxxx;2,2 xxxxxxxxxx
xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Streptococcus xxxxxxxxxx sérotypu 18C1,2 2,2 xxxxxxxxxx
xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 19X1,2&xxxx;2,2 xxxxxxxxxx
xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx pneumoniae xxxxxxxx 19X1,2&xxxx;2,2 xxxxxxxxxx
xxxxxxxxxxxx xxxxxxxx (pneumokoka) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 22F1,2 2,2 xxxxxxxxxx
xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 23X1,2&xxxx;2,2 xxxxxxxxxx
xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Streptococcus xxxxxxxxxx xxxxxxxx 33F1,2 2,2 xxxxxxxxxx
1 Xxxxxxxxxx x xxxxxx xxxxxxxxx CRM197 (přibližně 51 μg na xxxxx).
2 Xxxxxxxxxx na xxxxxxxxxxx hlinitý (0,125 xx hliníku xx xxxxx).
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Xxxxxxx:
xxxx. XXXx. Xxxxx, XXx, XXX, XXXX, x. x.
Xxxxxxxxx
Xxxxxx předpis x. 23/2024 Xx. nabyl xxxxxxxxx xxxx 8.2.2024.
Xx xxx xxxxxxxx xxxxxx xxxxxxx xxxxx xxxxx xx xxxxxxxxx.
Xxxxx xxxxxxxxxxxx xxxxxxxx xxxxx jiných xxxxxxxx xxxxxxxx v xxxxxxxx xxxx xxxxxxxxxxxxx, xxxxx xx xxxx xxxxxx xxxxxxxxx xxxxx xxxxx xxxxxxxxx xxxxxxxx xxxxxxxx.