Právní předpis byl sestaven k datu 16.06.2025.
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
XXXXXXX
Xxxxxxxxxxxx xxxxxxxxxxxxx
xx dne 29. ledna 2024
x xxxxxxxxxx složení xxxxxxxxxx xxxxx xxxxx xxxxxxxxxxxxx xxxxxxxx xxx očkování x dětském věku x x xxxxxxxxxx x xxxxxxxxxx xxxxxxx xxxxxxxxxxx stavu
Ministerstvo zdravotnictví xxxxx §30 xxxx. 2 písm. j) x k) xxxxxx x. 48/1997 Xx., x xxxxxxxx xxxxxxxxxx xxxxxxxxx x x xxxxx x xxxxxxxx xxxxxxxxx xxxxxxxxxxxxx zákonů, xx znění pozdějších xxxxxxxx, stanoví antigenní xxxxxxx xxxxxxxxxx xxxxx xxx xxxxxxxx xxxxx xxxxxxxxxxxxx xxxxxxxx x xxxxxxx xxxx x x pojištěnců x xxxxxxxxxx faktory zdravotního xxxxx:
1)&xxxx;13xxxxxxxx xxxxxxxxxxxxxxxx xxxxxxxxxxxx xxxxxxxx látku xxxxx xxxxxxxxxxxxx infekcím, xxxxx x xxxxx dávce (0,5 ml) xxxxxxxx:
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 11&xxxx;2,2 mikrogramů
Streptococci xxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 31&xxxx;2,2 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 41&xxxx;2,2 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 51&xxxx;2,2 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 6X1&xxxx;2,2 xxxxxxxxxx
Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 6B1 4,4 mikrogramů
Streptococci xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 7X1&xxxx;2,2 mikrogramů
Streptococci xxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 9X1&xxxx;2,2 xxxxxxxxxx
Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 141&xxxx;2,2 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum xxxxxxxxx 18X1&xxxx;2,2 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 19A1 2,2 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum xxxxxxxxx 19X1&xxxx;2,2 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 23X1&xxxx;2,2 mikrogramů
1 Xxxxxxxxxx x nosným xxxxxxxxx XXX197 x adsorbován xx xxxxxxxxxxx xxxxxxx.
XXXX
2)&xxxx;15xxxxxxxx xxxxxxxxxxxxxxxx xxxxxxxxxxxx xxxxxxxx xxxxx xxxxx xxxxxxxxxxxxx xxxxxxxx, xxxxx x xxxxx xxxxx (0,5 xx) xxxxxxxx:
Xxxxxxxxxxxx pneumoniae xxxxxxxx 11,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx serotypi 31,2&xxxx;xxxxxxxxxxxxxxx 2,0 mikrogramů
Streptococci xxxxxxxxxx xxxxxxxx 41,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 51,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx
Xxxxxxxxxxxx pneumoniae xxxxxxxx 6X1,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 6X1,2&xxxx;xxxxxxxxxxxxxxx 4,0 mikrogramů
Streptococci xxxxxxxxxx xxxxxxxx 7F1,2 polysaccharidum 2,0 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx serotypi 9X1,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx serotypi 141,2 polysaccharidum 2,0 mikrogramů
Streptococci xxxxxxxxxx xxxxxxxx 18X1,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx serotypi 19X1,2&xxxx;xxxxxxxxxxxxxxx 2,0 mikrogramů
Streptococci xxxxxxxxxx xxxxxxxx 19F1,2 polysaccharidum 2,0 mikrogramů
Streptococci pneumoniae xxxxxxxx 22X1,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 23X1,2&xxxx;xxxxxxxxxxxxxxx 2,0 mikrogramů
Streptococci xxxxxxxxxx xxxxxxxx 33F1,2 polysaccharidum 2,0 xxxxxxxxxx
1 Xxxxxxxxxx x xxxxxxxxxxx xxxxxxx XXX197. CRM197 je xxxxxxxxx xxxxxx xxxxxxxxxxxx xxxxxx (xxxxxxxxxxxxx x Xxxxxxxxxxxxxxx xxxxxxxxxxx X7) rekombinantně xxxxxxxxxxxxx v Pseudomonas xxxxxxxxxxx.
2 Xxxxxxxxxx xx xxxxxxxx xxxxxxxxxxx xxxxxxx.
XXXX
3)&xxxx;xxxxxxxx xxxxx xxxxx xxxxxxxxxxxxx xxxxxxxx používané x xxxxxxxxxx xxxxxxxx:
3x)&xxxx;13xxxxxxxx polysacharidovou xxxxxxxxxxxx xxxxxxxx xxxxx xxxxx xxxxxxxxxxxxx xxxxxxxx, xxxxx x jedné xxxxx (0,5 xx) xxxxxxxx:
Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 11&xxxx;2,2 mikrogramů
Streptococci xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 31&xxxx;2,2 mikrogramů
Streptococci xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 41&xxxx;2,2 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 51&xxxx;2,2 mikrogramů
Streptococci xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 6X1&xxxx;2,2 xxxxxxxxxx
Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 6X1&xxxx;4,4 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 7X1&xxxx;2,2 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 9X1&xxxx;2,2 mikrogramů
Streptococci xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 141&xxxx;2,2 xxxxxxxxxx
Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 18X1&xxxx;2,2 mikrogramů
Streptococci xxxxxxxxxx polysaccharidum xxxxxxxxx 19X1&xxxx;2,2 xxxxxxxxxx
Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx sérotypus 19X1&xxxx;2,2 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum xxxxxxxxx 23X1&xxxx;2,2 mikrogramů
1 Xxxxxxxxxx x nosným xxxxxxxxx XXX197&xxxx;x adsorbován xx xxxxxxxxxxx xxxxxxx.
X
3x)&xxxx;23xxxxxxxx xxxxxxxxxxxxxxxx xxxxxxxx látku xxxxx xxxxxxxxxxxxx xxxxxxxx, xxxxx v xxxxx xxxxx (0,5 xx) xxxxxxxx:
xx 25 xxxxxxxxxxxx xxxxxxxxxxxxx 23 xxxxxxxxxxxxxx xxxxxxxxxxxxxxxxx xxxxxxxx: 1, 2, 3, 4, 5, 6B, 7X, 8, 9N, 9V, 10X, HA, 12X, 14, 15X, 17X, 18X, 19F, 19X, 20, 22X, 23F, 33X
XXXX
4)&xxxx;xxxxxxxx xxxxx proti xxxxxxxxxxxxx xxxxxxxx používané x sekvenčním xxxxxxxx:
4x)&xxxx;15xxxxxxxx xxxxxxxxxxxxxxxx xxxxxxxxxxxx xxxxxxxx xxxxx xxxxx xxxxxxxxxxxxx xxxxxxxx, která x xxxxx xxxxx (0,5 xx) xxxxxxxx:
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 11,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx serotypi 31,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx serotypi 41,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 51,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx serotypi 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 xxxxxxxxxx serotypi 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 xxxxxxxx 19X1,2&xxxx;xxxxxxxxxxxxxxx 2,0 mikrogramů
Streptococci xxxxxxxxxx xxxxxxxx 19X1,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 22X1,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx serotypi 23X1,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 33F1,2 polysaccharidum 2,0 xxxxxxxxxx
1 Konjugován x proteinovým nosičem XXX197. XXX197&xxxx;xx xxxxxxxxx xxxxxx xxxxxxxxxxxx xxxxxx (xxxxxxxxxxxxx x Xxxxxxxxxxxxxxx xxxxxxxxxxx X7) rekombinantně xxxxxxxxxxxxx x Pseudomonas xxxxxxxxxxx.
2 Xxxxxxxxxx na xxxxxxxx fosforečnan xxxxxxx.
X
4x)&xxxx;23xxxxxxxx xxxxxxxxxxxxxxxx očkovací látku xxxxx xxxxxxxxxxxxx infekcím, xxxxx x xxxxx xxxxx (0,5 ml) xxxxxxxx:
xx 25 xxxxxxxxxxxx xxxxxxxxxxxxx 23 xxxxxxxxxxxxxx xxxxxxxxxxxxxxxxx xxxxxxxx: 1, 2, 3, 4, 5, 6B, 7X, 8, 9X, 9X, 10X, XX, 12F, 14, 15X, 17X, 18X, 19X, 19X, 20, 22X, 23F, 33X
XXXX
5)&xxxx;20xxxxxxxx xxxxxxxxxxxxxxxx xxxxxxxxxxxx xxxxxxxx xxxxx xxxxx xxxxxxxxxxxxx infekcím, xxxxx x xxxxx xxxxx (0,5 xx) xxxxxxxx:
Xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Streptococcus xxxxxxxxxx xxxxxxxx 11,2&xxxx;2,2 xxxxxxxxxx
xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 31,2&xxxx;2,2 xxxxxxxxxx
xxxxxxxxxxxx bakterie (xxxxxxxxxx) Streptococcus xxxxxxxxxx xxxxxxxx 41,2&xxxx;2,2 xxxxxxxxxx
xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 51,2&xxxx;2,2 xxxxxxxxxx
xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx pneumoniae xxxxxxxx 6X1,2&xxxx;2,2 mikrogramů
polysacharid xxxxxxxx (xxxxxxxxxx) Streptococcus pneumoniae xxxxxxxx 6B1,2 4,4 mikrogramů
polysacharid xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 7X1,2&xxxx;2,2 xxxxxxxxxx
xxxxxxxxxxxx bakterie (pneumokoka) Xxxxxxxxxxxxx pneumoniae sérotypů 81,2&xxxx;2,2 mikrogramů
polysacharid xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 9V1,2 2,2 xxxxxxxxxx
xxxxxxxxxxxx xxxxxxxx (pneumokoka) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 10X1,2&xxxx;2,2 xxxxxxxxxx
xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx pneumoniae sérotypu 11 X1,2&xxxx;2,2 mikrogramů
polysacharid xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 12X1,2&xxxx;2,2 xxxxxxxxxx
xxxxxxxxxxxx bakterie (xxxxxxxxxx) Xxxxxxxxxxxxx pneumoniae sérotypu 141,2&xxxx;2,2 mikrogramů
polysacharid xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 15B1,2 2,2 mikrogramů
polysacharid xxxxxxxx (xxxxxxxxxx) Streptococcus xxxxxxxxxx xxxxxxxx 18C1,2 2,2 xxxxxxxxxx
xxxxxxxxxxxx xxxxxxxx (pneumokoka) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 19X1,2&xxxx;2,2 xxxxxxxxxx
xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 19X1,2&xxxx;2,2 xxxxxxxxxx
xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Streptococcus xxxxxxxxxx xxxxxxxx 22X1,2&xxxx;2,2 xxxxxxxxxx
xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx sérotypu 23X1,2&xxxx;2,2 xxxxxxxxxx
xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx pneumoniae xxxxxxxx 33X1,2&xxxx;2,2 xxxxxxxxxx
1 Xxxxxxxxxx s xxxxxx xxxxxxxxx XXX197 (přibližně 51 μx xx xxxxx).
2 Xxxxxxxxxx xx xxxxxxxxxxx xxxxxxx (0,125 xx xxxxxxx na xxxxx).
&xxxx;
Xxxxxxx:
xxxx. XXXx. Xxxxx, XXx, XXX, XXXX, x. x.
Xxxxxxxxx
Xxxxxx xxxxxxx č. 23/2024 Xx. nabyl xxxxxxxxx xxxx 8.2.2024.
Xx xxx xxxxxxxx xxxxxx xxxxxxx xxxxx xxxxx xx xxxxxxxxx.
Xxxxx jednotlivých xxxxxxxx norem jiných xxxxxxxx předpisů x xxxxxxxx xxxx xxxxxxxxxxxxx, xxxxx se jich xxxxxx derogační xxxxx xxxxx xxxxxxxxx xxxxxxxx xxxxxxxx.