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
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Xxxxxxxxxxxx zdravotnictví
ze xxx 29. xxxxx 2024
o xxxxxxxxxx složení xxxxxxxxxx xxxxx xxxxx pneumokokovým xxxxxxxx xxx xxxxxxxx x xxxxxxx věku x u xxxxxxxxxx x xxxxxxxxxx xxxxxxx xxxxxxxxxxx stavu
Ministerstvo xxxxxxxxxxxxx xxxxx §30 xxxx. 2 xxxx. x) x x) zákona x. 48/1997 Xx., x xxxxxxxx xxxxxxxxxx xxxxxxxxx x x xxxxx a doplnění xxxxxxxxx xxxxxxxxxxxxx zákonů, xx znění xxxxxxxxxx xxxxxxxx, stanoví antigenní xxxxxxx xxxxxxxxxx látek xxx očkování xxxxx xxxxxxxxxxxxx xxxxxxxx x xxxxxxx xxxx x x pojištěnců s xxxxxxxxxx xxxxxxx xxxxxxxxxxx xxxxx:
1)&xxxx;13xxxxxxxx xxxxxxxxxxxxxxxx xxxxxxxxxxxx xxxxxxxx xxxxx xxxxx xxxxxxxxxxxxx xxxxxxxx, xxxxx x jedné xxxxx (0,5 xx) obsahuje:
Streptococci xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 11&xxxx;2,2 mikrogramů
Streptococci xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 31&xxxx;2,2 xxxxxxxxxx
Xxxxxxxxxxxx pneumoniae polysaccharidum xxxxxxxxx 41&xxxx;2,2 mikrogramů
Streptococci xxxxxxxxxx polysaccharidum xxxxxxxxx 51&xxxx;2,2 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 6A1 2,2 xxxxxxxxxx
Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 6X1&xxxx;4,4 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum xxxxxxxxx 7X1&xxxx;2,2 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 9X1&xxxx;2,2 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 141&xxxx;2,2 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 18X1&xxxx;2,2 mikrogramů
Streptococci xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 19X1&xxxx;2,2 xxxxxxxxxx
Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 19X1&xxxx;2,2 mikrogramů
Streptococci xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 23X1&xxxx;2,2 xxxxxxxxxx
1 Xxxxxxxxxx x xxxxxx xxxxxxxxx XXX197 a xxxxxxxxxx xx xxxxxxxxxxx hlinitý.
NEBO
2) 15valentní xxxxxxxxxxxxxxxx xxxxxxxxxxxx xxxxxxxx xxxxx xxxxx xxxxxxxxxxxxx xxxxxxxx, xxxxx v xxxxx xxxxx (0,5 xx) obsahuje:
Streptococci pneumoniae xxxxxxxx 11,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx serotypi 31,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 41,2&xxxx;xxxxxxxxxxxxxxx 2,0 mikrogramů
Streptococci xxxxxxxxxx xxxxxxxx 51,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx
Xxxxxxxxxxxx pneumoniae serotypi 6X1,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 6B1,2 polysaccharidum 4,0 mikrogramů
Streptococci pneumoniae xxxxxxxx 7X1,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 9X1,2&xxxx;xxxxxxxxxxxxxxx 2,0 mikrogramů
Streptococci xxxxxxxxxx xxxxxxxx 141,2 polysaccharidum 2,0 mikrogramů
Streptococci pneumoniae xxxxxxxx 18X1,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx
Xxxxxxxxxxxx pneumoniae serotypi 19X1,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 19X1,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx
Xxxxxxxxxxxx pneumoniae xxxxxxxx 22X1,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 23X1,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 33F1,2 polysaccharidum 2,0 mikrogramů
1 Xxxxxxxxxx x xxxxxxxxxxx xxxxxxx XXX197. XXX197&xxxx;xx xxxxxxxxx xxxxxx difterického xxxxxx (xxxxxxxxxxxxx x Xxxxxxxxxxxxxxx xxxxxxxxxxx X7) xxxxxxxxxxxxx xxxxxxxxxxxxx v Xxxxxxxxxxx xxxxxxxxxxx.
2 Xxxxxxxxxx xx xxxxxxxx fosforečnan xxxxxxx.
XXXX
3)&xxxx;xxxxxxxx xxxxx proti pneumokokovým xxxxxxxx používané x xxxxxxxxxx schématu:
3a) 13valentní xxxxxxxxxxxxxxxx xxxxxxxxxxxx očkovací xxxxx xxxxx xxxxxxxxxxxxx xxxxxxxx, xxxxx x jedné xxxxx (0,5 xx) xxxxxxxx:
Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum xxxxxxxxx 11&xxxx;2,2 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 31&xxxx;2,2 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 41&xxxx;2,2 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum xxxxxxxxx 51&xxxx;2,2 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 6X1&xxxx;2,2 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 6X1&xxxx;4,4 xxxxxxxxxx
Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 7X1&xxxx;2,2 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 9X1&xxxx;2,2 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 141&xxxx;2,2 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 18X1&xxxx;2,2 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 19X1&xxxx;2,2 mikrogramů
Streptococci pneumoniae xxxxxxxxxxxxxxx sérotypus 19X1&xxxx;2,2 xxxxxxxxxx
Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 23X1&xxxx;2,2 xxxxxxxxxx
1 Xxxxxxxxxx x nosným xxxxxxxxx XXX197&xxxx;x adsorbován xx fosforečnan hlinitý.
A
3b) 23valentní xxxxxxxxxxxxxxxx xxxxxxxx xxxxx xxxxx xxxxxxxxxxxxx xxxxxxxx, xxxxx x xxxxx xxxxx (0,5 xx) xxxxxxxx:
xx 25 xxxxxxxxxxxx xxxxxxxxxxxxx 23 xxxxxxxxxxxxxx xxxxxxxxxxxxxxxxx sérotypů: 1, 2, 3, 4, 5, 6X, 7X, 8, 9X, 9X, 10X, HA, 12X, 14, 15B, 17X, 18X, 19X, 19X, 20, 22X, 23X, 33X
XXXX
4)&xxxx;xxxxxxxx xxxxx proti xxxxxxxxxxxxx infekcím používané x sekvenčním xxxxxxxx:
4x)&xxxx;15xxxxxxxx xxxxxxxxxxxxxxxx xxxxxxxxxxxx xxxxxxxx xxxxx xxxxx xxxxxxxxxxxxx xxxxxxxx, xxxxx x xxxxx xxxxx (0,5 xx) obsahuje:
Streptococci xxxxxxxxxx xxxxxxxx 11,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx
Xxxxxxxxxxxx pneumoniae serotypi 31,2&xxxx;xxxxxxxxxxxxxxx 2,0 mikrogramů
Streptococci xxxxxxxxxx xxxxxxxx 41,2 polysaccharidum 2,0 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 51,2 polysaccharidum 2,0 xxxxxxxxxx
Xxxxxxxxxxxx pneumoniae 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 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 141,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 18X1,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx
Xxxxxxxxxxxx pneumoniae serotypi 19X1,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 19X1,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 22X1,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 23X1,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 33X1,2&xxxx;xxxxxxxxxxxxxxx 2,0 mikrogramů
1 Xxxxxxxxxx x xxxxxxxxxxx nosičem XXX197. XXX197&xxxx;xx xxxxxxxxx xxxxxx difterického xxxxxx (xxxxxxxxxxxxx x Xxxxxxxxxxxxxxx xxxxxxxxxxx X7) rekombinantně xxxxxxxxxxxxx x Xxxxxxxxxxx xxxxxxxxxxx.
2 Xxxxxxxxxx xx xxxxxxxx fosforečnan xxxxxxx.
X
4x)&xxxx;23xxxxxxxx xxxxxxxxxxxxxxxx xxxxxxxx látku xxxxx xxxxxxxxxxxxx xxxxxxxx, xxxxx x jedné xxxxx (0,5 ml) xxxxxxxx:
xx 25 mikrogramech xxxxxxxxxxxxx 23 pneumokokových xxxxxxxxxxxxxxxxx xxxxxxxx: 1, 2, 3, 4, 5, 6B, 7X, 8, 9X, 9X, 10X, XX, 12X, 14, 15B, 17X, 18X, 19F, 19X, 20, 22X, 23X, 33X
XXXX
5)&xxxx;20xxxxxxxx xxxxxxxxxxxxxxxx konjugovanou xxxxxxxx xxxxx proti xxxxxxxxxxxxx xxxxxxxx, která x xxxxx xxxxx (0,5 ml) obsahuje:
Polysacharid xxxxxxxx (pneumokoka) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 11,2&xxxx;2,2 xxxxxxxxxx
xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 31,2&xxxx;2,2 mikrogramů
polysacharid xxxxxxxx (xxxxxxxxxx) Streptococcus xxxxxxxxxx xxxxxxxx 41,2 2,2 xxxxxxxxxx
xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Streptococcus xxxxxxxxxx xxxxxxxx 51,2&xxxx;2,2 xxxxxxxxxx
xxxxxxxxxxxx bakterie (xxxxxxxxxx) Xxxxxxxxxxxxx pneumoniae xxxxxxxx 6X1,2&xxxx;2,2 xxxxxxxxxx
xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 6B1,2 4,4 mikrogramů
polysacharid xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx sérotypů 7X1,2&xxxx;2,2 xxxxxxxxxx
xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx pneumoniae xxxxxxxx 81,2&xxxx;2,2 xxxxxxxxxx
xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Streptococcus pneumoniae xxxxxxxx 9X1,2&xxxx;2,2 mikrogramů
polysacharid xxxxxxxx (xxxxxxxxxx) Streptococcus xxxxxxxxxx sérotypu 10X1,2&xxxx;2,2 xxxxxxxxxx
xxxxxxxxxxxx bakterie (xxxxxxxxxx) Xxxxxxxxxxxxx pneumoniae xxxxxxxx 11 X1,2&xxxx;2,2 xxxxxxxxxx
xxxxxxxxxxxx xxxxxxxx (pneumokoka) Streptococcus xxxxxxxxxx xxxxxxxx 12X1,2&xxxx;2,2 xxxxxxxxxx
xxxxxxxxxxxx xxxxxxxx (pneumokoka) Xxxxxxxxxxxxx pneumoniae sérotypu 141,2&xxxx;2,2 xxxxxxxxxx
xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx pneumoniae xxxxxxxx 15B1,2 2,2 mikrogramů
polysacharid xxxxxxxx (pneumokoka) Xxxxxxxxxxxxx xxxxxxxxxx sérotypu 18X1,2&xxxx;2,2 xxxxxxxxxx
xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx pneumoniae xxxxxxxx 19X1,2&xxxx;2,2 mikrogramů
polysacharid bakterie (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 19F1,2 2,2 xxxxxxxxxx
xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx sérotypu 22X1,2&xxxx;2,2 xxxxxxxxxx
xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx pneumoniae xxxxxxxx 23X1,2&xxxx;2,2 xxxxxxxxxx
xxxxxxxxxxxx bakterie (xxxxxxxxxx) Streptococcus xxxxxxxxxx xxxxxxxx 33F1,2 2,2 mikrogramů
1 Xxxxxxxxxx x nosným xxxxxxxxx CRM197 (přibližně 51 μx na xxxxx).
2 Xxxxxxxxxx xx xxxxxxxxxxx xxxxxxx (0,125 xx hliníku xx xxxxx).
&xxxx;
Xxxxxxx:
xxxx. XXXx. Válek, XXx, MBA, EBIR, x. x.
Informace
Právní xxxxxxx č. 23/2024 Xx. nabyl xxxxxxxxx xxxx 8.2.2024.
Xx xxx uzávěrky xxxxxx xxxxxxx xxxxx xxxxx xx doplňován.
Znění xxxxxxxxxxxx xxxxxxxx norem jiných xxxxxxxx předpisů x xxxxxxxx xxxx xxxxxxxxxxxxx, xxxxx xx jich xxxxxx xxxxxxxxx xxxxx xxxxx xxxxxxxxx právního xxxxxxxx.