Právní předpis byl sestaven k datu 29.04.2024.
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
o xxxxxxxxxx složení xxxxxxxxxx xxxxx xxxxx pneumokokovým xxxxxxxx xxx xxxxxxxx x xxxxxxx věku x x pojištěnců x rizikovými faktory xxxxxxxxxxx xxxxx
&xxxx;
Xxxxxxxxxxxx zdravotnictví xxxxx §30 odst. 2 písm. x) x k) zákona x. 48/1997 Xx., x xxxxxxxx xxxxxxxxxx xxxxxxxxx x x xxxxx x doplnění xxxxxxxxx souvisejících xxxxxx, xx xxxxx xxxxxxxxxx xxxxxxxx, xxxxxxx antigenní xxxxxxx očkovacích látek xxx xxxxxxxx proti xxxxxxxxxxxxx xxxxxxxx x xxxxxxx věku x x xxxxxxxxxx s xxxxxxxxxx faktory xxxxxxxxxxx xxxxx:
1)&xxxx;13xxxxxxxx xxxxxxxxxxxxxxxx konjugovanou xxxxxxxx xxxxx xxxxx xxxxxxxxxxxxx infekcím, která x jedné xxxxx (0,5 xx) xxxxxxxx:
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 11&xxxx;2,2 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 31&xxxx;2,2 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum xxxxxxxxx 41 2,2 mikrogramů
Streptococci xxxxxxxxxx polysaccharidum sérotypus 51&xxxx;2,2 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 6X1&xxxx;2,2 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum xxxxxxxxx 6X1&xxxx;4,4 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 7X1&xxxx;2,2 xxxxxxxxxx
Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 9V1 2,2 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 141&xxxx;2,2 mikrogramů
Streptococci xxxxxxxxxx polysaccharidum sérotypus 18X1&xxxx;2,2 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 19X1&xxxx;2,2 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum xxxxxxxxx 19X1&xxxx;2,2 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum xxxxxxxxx 23X1&xxxx;2,2 mikrogramů
1 Xxxxxxxxxx x nosným xxxxxxxxx XXX197 x xxxxxxxxxx xx xxxxxxxxxxx hlinitý.
NEBO
2) 15valentní xxxxxxxxxxxxxxxx xxxxxxxxxxxx očkovací xxxxx xxxxx xxxxxxxxxxxxx xxxxxxxx, která x xxxxx dávce (0,5 xx) xxxxxxxx:
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 11,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 31,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 41,2 polysaccharidum 2,0 xxxxxxxxxx
Xxxxxxxxxxxx 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 polysaccharidum 2,0 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 18X1,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx serotypi 19X1,2&xxxx;xxxxxxxxxxxxxxx 2,0 mikrogramů
Streptococci xxxxxxxxxx xxxxxxxx 19X1,2&xxxx;xxxxxxxxxxxxxxx 2,0 mikrogramů
Streptococci xxxxxxxxxx xxxxxxxx 22X1,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx serotypi 23X1,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 33X1,2&xxxx;xxxxxxxxxxxxxxx 2,0 mikrogramů
1 Xxxxxxxxxx x proteinovým nosičem XXX197. XXX197&xxxx;xx xxxxxxxxx xxxxxx xxxxxxxxxxxx xxxxxx (xxxxxxxxxxxxx z Xxxxxxxxxxxxxxx xxxxxxxxxxx C7) xxxxxxxxxxxxx xxxxxxxxxxxxx x Xxxxxxxxxxx xxxxxxxxxxx.
2 Xxxxxxxxxx xx xxxxxxxx xxxxxxxxxxx hlinitý.
NEBO
3) očkovací xxxxx xxxxx xxxxxxxxxxxxx xxxxxxxx xxxxxxxxx v xxxxxxxxxx schématu:
3a) 13valentní polysacharidovou xxxxxxxxxxxx xxxxxxxx xxxxx xxxxx xxxxxxxxxxxxx xxxxxxxx, xxxxx v xxxxx xxxxx (0,5 xx) xxxxxxxx:
Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 11&xxxx;2,2 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 31&xxxx;2,2 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 41 2,2 xxxxxxxxxx
Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 51&xxxx;2,2 mikrogramů
Streptococci xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 6X1&xxxx;2,2 xxxxxxxxxx
Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 6B1 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 polysaccharidum 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 s nosným xxxxxxxxx CRM197 a adsorbován xx xxxxxxxxxxx xxxxxxx.
X
3x)&xxxx;23xxxxxxxx xxxxxxxxxxxxxxxx xxxxxxxx xxxxx xxxxx xxxxxxxxxxxxx xxxxxxxx, xxxxx x xxxxx xxxxx (0,5 ml) xxxxxxxx:
xx 25 mikrogramech xxxxxxxxxxxxx 23 xxxxxxxxxxxxxx xxxxxxxxxxxxxxxxx xxxxxxxx: 1, 2, 3, 4, 5, 6X, 7F, 8, 9N, 9X, 10X, HA, 12X, 14, 15X, 17F, 18X, 19X, 19A, 20, 22X, 23X, 33X
XXXX
4)&xxxx;xxxxxxxx xxxxx xxxxx xxxxxxxxxxxxx xxxxxxxx používané x sekvenčním schématu:
4a) 15valentní xxxxxxxxxxxxxxxx konjugovanou očkovací xxxxx proti xxxxxxxxxxxxx xxxxxxxx, xxxxx x 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 mikrogramů
Streptococci xxxxxxxxxx xxxxxxxx 41,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx
Xxxxxxxxxxxx pneumoniae 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 xxxxxxxxxx serotypi 9X1,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx serotypi 141,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx
Xxxxxxxxxxxx pneumoniae xxxxxxxx 18X1,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx
Xxxxxxxxxxxx pneumoniae xxxxxxxx 19X1,2&xxxx;xxxxxxxxxxxxxxx 2,0 mikrogramů
Streptococci xxxxxxxxxx xxxxxxxx 19F1,2 polysaccharidum 2,0 mikrogramů
Streptococci xxxxxxxxxx xxxxxxxx 22F1,2 polysaccharidum 2,0 xxxxxxxxxx
Xxxxxxxxxxxx pneumoniae xxxxxxxx 23X1,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 33X1,2&xxxx;xxxxxxxxxxxxxxx 2,0 mikrogramů
1 Konjugován x xxxxxxxxxxx xxxxxxx XXX197. XXX197&xxxx;xx netoxická xxxxxx xxxxxxxxxxxx xxxxxx (xxxxxxxxxxxxx x Xxxxxxxxxxxxxxx xxxxxxxxxxx X7) xxxxxxxxxxxxx xxxxxxxxxxxxx v Pseudomonas xxxxxxxxxxx.
2 Adsorbován na xxxxxxxx xxxxxxxxxxx xxxxxxx.
X
4x)&xxxx;23xxxxxxxx xxxxxxxxxxxxxxxx xxxxxxxx látku xxxxx xxxxxxxxxxxxx xxxxxxxx, xxxxx x jedné xxxxx (0,5 xx) xxxxxxxx:
xx 25 xxxxxxxxxxxx xxxxxxxxxxxxx 23 xxxxxxxxxxxxxx xxxxxxxxxxxxxxxxx sérotypů: 1, 2, 3, 4, 5, 6B, 7X, 8, 9X, 9V, 10X, HA, 12X, 14, 15X, 17X, 18X, 19F, 19X, 20, 22X, 23F, 33X
XXXX
5)&xxxx;20xxxxxxxx polysacharidovou xxxxxxxxxxxx xxxxxxxx látku xxxxx xxxxxxxxxxxxx xxxxxxxx, která x xxxxx xxxxx (0,5 ml) obsahuje:
Polysacharid xxxxxxxx (pneumokoka) Xxxxxxxxxxxxx xxxxxxxxxx sérotypů 11,2 2,2 xxxxxxxxxx
xxxxxxxxxxxx xxxxxxxx (pneumokoka) Xxxxxxxxxxxxx xxxxxxxxxx sérotypů 31,2&xxxx;2,2 xxxxxxxxxx
xxxxxxxxxxxx bakterie (xxxxxxxxxx) Xxxxxxxxxxxxx pneumoniae xxxxxxxx 41,2&xxxx;2,2 xxxxxxxxxx
xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Streptococcus xxxxxxxxxx sérotypů 51,2&xxxx;2,2 xxxxxxxxxx
xxxxxxxxxxxx xxxxxxxx (pneumokoka) Xxxxxxxxxxxxx xxxxxxxxxx sérotypů 6X1,2&xxxx;2,2 xxxxxxxxxx
xxxxxxxxxxxx bakterie (xxxxxxxxxx) Xxxxxxxxxxxxx pneumoniae xxxxxxxx 6B1,2 4,4 xxxxxxxxxx
xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx sérotypů 7X1,2&xxxx;2,2 xxxxxxxxxx
xxxxxxxxxxxx bakterie (pneumokoka) Xxxxxxxxxxxxx pneumoniae xxxxxxxx 81,2&xxxx;2,2 xxxxxxxxxx
xxxxxxxxxxxx bakterie (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 9X1,2&xxxx;2,2 mikrogramů
polysacharid xxxxxxxx (pneumokoka) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 10X1,2&xxxx;2,2 xxxxxxxxxx
xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx pneumoniae xxxxxxxx 11 X1,2&xxxx;2,2 xxxxxxxxxx
xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 12X1,2&xxxx;2,2 xxxxxxxxxx
xxxxxxxxxxxx bakterie (xxxxxxxxxx) Xxxxxxxxxxxxx pneumoniae sérotypu 141,2&xxxx;2,2 mikrogramů
polysacharid bakterie (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 15X1,2&xxxx;2,2 xxxxxxxxxx
xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 18X1,2&xxxx;2,2 xxxxxxxxxx
xxxxxxxxxxxx xxxxxxxx (pneumokoka) Xxxxxxxxxxxxx xxxxxxxxxx sérotypu 19X1,2&xxxx;2,2 mikrogramů
polysacharid bakterie (xxxxxxxxxx) Xxxxxxxxxxxxx pneumoniae xxxxxxxx 19X1,2&xxxx;2,2 xxxxxxxxxx
xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 22F1,2 2,2 xxxxxxxxxx
xxxxxxxxxxxx xxxxxxxx (pneumokoka) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 23X1,2&xxxx;2,2 xxxxxxxxxx
xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 33X1,2&xxxx;2,2 xxxxxxxxxx
1 Xxxxxxxxxx x nosným xxxxxxxxx CRM197 (xxxxxxxxx 51 μx na xxxxx).
2 Xxxxxxxxxx xx xxxxxxxxxxx hlinitý (0,125 xx xxxxxxx xx xxxxx).
&xxxx;
Xxxxxxx:
xxxx. MUDr. Xxxxx, XXx, XXX, EBIR, x. r.
Xxxxxxxxx
Xxxxxx xxxxxxx x. 23/2024 Sb. xxxxx xxxxxxxxx dnem 8.2.2024.
Ke xxx uzávěrky xxxxxx xxxxxxx nebyl měněn xx doplňován.
Znění jednotlivých xxxxxxxx xxxxx jiných xxxxxxxx xxxxxxxx x xxxxxxxx není xxxxxxxxxxxxx, xxxxx se jich xxxxxx xxxxxxxxx xxxxx xxxxx uvedeného xxxxxxxx xxxxxxxx.