Právní předpis byl sestaven k datu 05.02.2025.
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
SDĚLENÍ
Ministerstva zdravotnictví
ze dne 29. ledna 2024
x xxxxxxxxxx xxxxxxx xxxxxxxxxx xxxxx xxxxx pneumokokovým xxxxxxxx pro xxxxxxxx x xxxxxxx věku x x xxxxxxxxxx x rizikovými faktory xxxxxxxxxxx xxxxx
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Xxxxxxxxxxxx xxxxxxxxxxxxx xxxxx §30 xxxx. 2 xxxx. x) x k) zákona x. 48/1997 Xx., x veřejném xxxxxxxxxx xxxxxxxxx x x xxxxx a xxxxxxxx xxxxxxxxx souvisejících xxxxxx, xx xxxxx xxxxxxxxxx xxxxxxxx, xxxxxxx xxxxxxxxx xxxxxxx očkovacích xxxxx xxx xxxxxxxx xxxxx xxxxxxxxxxxxx xxxxxxxx x xxxxxxx xxxx x x pojištěnců x xxxxxxxxxx xxxxxxx xxxxxxxxxxx xxxxx:
1)&xxxx;13xxxxxxxx xxxxxxxxxxxxxxxx xxxxxxxxxxxx xxxxxxxx xxxxx xxxxx xxxxxxxxxxxxx xxxxxxxx, která x jedné xxxxx (0,5 xx) obsahuje:
Streptococci xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 11&xxxx;2,2 mikrogramů
Streptococci pneumoniae xxxxxxxxxxxxxxx sérotypus 31&xxxx;2,2 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum xxxxxxxxx 41&xxxx;2,2 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 51&xxxx;2,2 mikrogramů
Streptococci xxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 6A1 2,2 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 6X1&xxxx;4,4 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 7X1&xxxx;2,2 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 9X1&xxxx;2,2 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 141 2,2 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum sérotypus 18X1&xxxx;2,2 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 19X1&xxxx;2,2 xxxxxxxxxx
Xxxxxxxxxxxx pneumoniae polysaccharidum xxxxxxxxx 19X1&xxxx;2,2 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 23X1&xxxx;2,2 xxxxxxxxxx
1 Xxxxxxxxxx x nosným proteinem XXX197 x xxxxxxxxxx xx xxxxxxxxxxx xxxxxxx.
XXXX
2)&xxxx;15xxxxxxxx xxxxxxxxxxxxxxxx konjugovanou xxxxxxxx xxxxx xxxxx xxxxxxxxxxxxx xxxxxxxx, xxxxx v xxxxx xxxxx (0,5 xx) obsahuje:
Streptococci xxxxxxxxxx xxxxxxxx 11,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 31,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 41,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx
Xxxxxxxxxxxx pneumoniae xxxxxxxx 51,2 polysaccharidum 2,0 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 6X1,2&xxxx;xxxxxxxxxxxxxxx 2,0 mikrogramů
Streptococci xxxxxxxxxx serotypi 6X1,2&xxxx;xxxxxxxxxxxxxxx 4,0 xxxxxxxxxx
Xxxxxxxxxxxx pneumoniae xxxxxxxx 7F1,2 polysaccharidum 2,0 xxxxxxxxxx
Xxxxxxxxxxxx pneumoniae serotypi 9X1,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 141,2 polysaccharidum 2,0 mikrogramů
Streptococci xxxxxxxxxx xxxxxxxx 18X1,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 19X1,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx serotypu 19F1,2 polysaccharidum 2,0 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 22X1,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx serotypi 23X1,2&xxxx;xxxxxxxxxxxxxxx 2,0 mikrogramů
Streptococci xxxxxxxxxx xxxxxxxx 33X1,2&xxxx;xxxxxxxxxxxxxxx 2,0 mikrogramů
1 Konjugován x proteinovým xxxxxxx XXX197. XXX197&xxxx;xx xxxxxxxxx xxxxxx xxxxxxxxxxxx xxxxxx (xxxxxxxxxxxxx z Xxxxxxxxxxxxxxx xxxxxxxxxxx X7) rekombinantně xxxxxxxxxxxxx x Xxxxxxxxxxx xxxxxxxxxxx.
2 Xxxxxxxxxx na xxxxxxxx xxxxxxxxxxx xxxxxxx.
XXXX
3)&xxxx;xxxxxxxx xxxxx xxxxx pneumokokovým xxxxxxxx xxxxxxxxx x xxxxxxxxxx xxxxxxxx:
3x)&xxxx;13xxxxxxxx xxxxxxxxxxxxxxxx xxxxxxxxxxxx xxxxxxxx látku xxxxx xxxxxxxxxxxxx infekcím, xxxxx v xxxxx xxxxx (0,5 xx) xxxxxxxx:
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 11 2,2 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 31&xxxx;2,2 mikrogramů
Streptococci xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 41&xxxx;2,2 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum xxxxxxxxx 51&xxxx;2,2 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum sérotypus 6X1&xxxx;2,2 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 6X1&xxxx;4,4 xxxxxxxxxx
Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 7F1 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 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum xxxxxxxxx 19X1&xxxx;2,2 xxxxxxxxxx
Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 19X1&xxxx;2,2 xxxxxxxxxx
Xxxxxxxxxxxx pneumoniae polysaccharidum xxxxxxxxx 23X1&xxxx;2,2 xxxxxxxxxx
1 Xxxxxxxxxx x nosným xxxxxxxxx CRM197 a xxxxxxxxxx xx xxxxxxxxxxx xxxxxxx.
X
3x)&xxxx;23xxxxxxxx xxxxxxxxxxxxxxxx xxxxxxxx xxxxx xxxxx xxxxxxxxxxxxx xxxxxxxx, xxxxx x xxxxx xxxxx (0,5 xx) xxxxxxxx:
xx 25 mikrogramech xxxxxxxxxxxxx 23 xxxxxxxxxxxxxx xxxxxxxxxxxxxxxxx sérotypů: 1, 2, 3, 4, 5, 6X, 7X, 8, 9N, 9X, 10X, XX, 12X, 14, 15X, 17X, 18X, 19F, 19A, 20, 22X, 23F, 33X
XXXX
4)&xxxx;xxxxxxxx xxxxx xxxxx xxxxxxxxxxxxx xxxxxxxx xxxxxxxxx x xxxxxxxxxx schématu:
4a) 15valentní xxxxxxxxxxxxxxxx xxxxxxxxxxxx xxxxxxxx xxxxx proti xxxxxxxxxxxxx xxxxxxxx, xxxxx x xxxxx xxxxx (0,5 xx) xxxxxxxx:
Xxxxxxxxxxxx pneumoniae xxxxxxxx 11,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 31,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx serotypi 41,2 polysaccharidum 2,0 mikrogramů
Streptococci pneumoniae xxxxxxxx 51,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx
Xxxxxxxxxxxx pneumoniae 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 xxxxxxxx 9X1,2&xxxx;xxxxxxxxxxxxxxx 2,0 mikrogramů
Streptococci xxxxxxxxxx serotypi 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 serotypu 19X1,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx
Xxxxxxxxxxxx pneumoniae xxxxxxxx 22F1,2 polysaccharidum 2,0 xxxxxxxxxx
Xxxxxxxxxxxx pneumoniae xxxxxxxx 23X1,2&xxxx;xxxxxxxxxxxxxxx 2,0 mikrogramů
Streptococci xxxxxxxxxx serotypi 33F1,2 polysaccharidum 2,0 mikrogramů
1 Xxxxxxxxxx x proteinovým xxxxxxx XXX197. XXX197&xxxx;xx netoxická xxxxxx xxxxxxxxxxxx xxxxxx (xxxxxxxxxxxxx x Xxxxxxxxxxxxxxx xxxxxxxxxxx X7) rekombinantně xxxxxxxxxxxxx x Pseudomonas xxxxxxxxxxx.
2 Xxxxxxxxxx xx xxxxxxxx fosforečnan xxxxxxx.
X
4x)&xxxx;23xxxxxxxx xxxxxxxxxxxxxxxx xxxxxxxx xxxxx xxxxx xxxxxxxxxxxxx infekcím, xxxxx x xxxxx xxxxx (0,5 xx) xxxxxxxx:
xx 25 xxxxxxxxxxxx xxxxxxxxxxxxx 23 xxxxxxxxxxxxxx xxxxxxxxxxxxxxxxx sérotypů: 1, 2, 3, 4, 5, 6B, 7X, 8, 9X, 9X, 10X, XX, 12X, 14, 15X, 17F, 18X, 19X, 19X, 20, 22F, 23X, 33X
XXXX
5)&xxxx;20xxxxxxxx xxxxxxxxxxxxxxxx konjugovanou xxxxxxxx xxxxx proti xxxxxxxxxxxxx infekcím, která x jedné dávce (0,5 ml) xxxxxxxx:
Xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx sérotypů 11,2 2,2 xxxxxxxxxx
xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx pneumoniae xxxxxxxx 31,2&xxxx;2,2 mikrogramů
polysacharid xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx pneumoniae xxxxxxxx 41,2&xxxx;2,2 xxxxxxxxxx
xxxxxxxxxxxx xxxxxxxx (pneumokoka) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 51,2 2,2 xxxxxxxxxx
xxxxxxxxxxxx bakterie (pneumokoka) Xxxxxxxxxxxxx pneumoniae xxxxxxxx 6X1,2&xxxx;2,2 mikrogramů
polysacharid bakterie (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 6X1,2&xxxx;4,4 xxxxxxxxxx
xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx sérotypů 7X1,2&xxxx;2,2 xxxxxxxxxx
xxxxxxxxxxxx bakterie (xxxxxxxxxx) Xxxxxxxxxxxxx pneumoniae xxxxxxxx 81,2&xxxx;2,2 mikrogramů
polysacharid xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx pneumoniae xxxxxxxx 9X1,2&xxxx;2,2 mikrogramů
polysacharid xxxxxxxx (xxxxxxxxxx) Streptococcus xxxxxxxxxx sérotypu 10X1,2&xxxx;2,2 xxxxxxxxxx
xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx pneumoniae sérotypu 11 A1,2 2,2 mikrogramů
polysacharid xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 12X1,2&xxxx;2,2 xxxxxxxxxx
xxxxxxxxxxxx bakterie (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx sérotypu 141,2&xxxx;2,2 xxxxxxxxxx
xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 15X1,2&xxxx;2,2 xxxxxxxxxx
xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Streptococcus xxxxxxxxxx xxxxxxxx 18C1,2 2,2 xxxxxxxxxx
xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx pneumoniae xxxxxxxx 19X1,2&xxxx;2,2 mikrogramů
polysacharid bakterie (xxxxxxxxxx) Xxxxxxxxxxxxx pneumoniae xxxxxxxx 19F1,2 2,2 mikrogramů
polysacharid xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 22X1,2&xxxx;2,2 xxxxxxxxxx
xxxxxxxxxxxx xxxxxxxx (pneumokoka) Xxxxxxxxxxxxx pneumoniae xxxxxxxx 23X1,2&xxxx;2,2 xxxxxxxxxx
xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx pneumoniae xxxxxxxx 33X1,2&xxxx;2,2 xxxxxxxxxx
1 Xxxxxxxxxx x xxxxxx xxxxxxxxx CRM197 (xxxxxxxxx 51 μg xx xxxxx).
2 Xxxxxxxxxx xx xxxxxxxxxxx hlinitý (0,125 xx xxxxxxx na xxxxx).
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Xxxxxxx:
xxxx. MUDr. Válek, XXx, XXX, XXXX, x. x.
Informace
Právní xxxxxxx x. 23/2024 Sb. nabyl xxxxxxxxx xxxx 8.2.2024.
Ke xxx xxxxxxxx právní xxxxxxx nebyl xxxxx xx xxxxxxxxx.
Xxxxx xxxxxxxxxxxx xxxxxxxx xxxxx jiných xxxxxxxx xxxxxxxx v xxxxxxxx xxxx xxxxxxxxxxxxx, xxxxx xx jich xxxxxx xxxxxxxxx xxxxx xxxxx xxxxxxxxx xxxxxxxx xxxxxxxx.