Plné znění - 23/2024 Sb.

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.
 

Sdělení Ministerstva zdravotnictví

INFORMACE

23

SDĚLENÍ

Ministerstva zdravotnictví

ze xxx 29. ledna 2024

x xxxxxxxxxx složení xxxxxxxxxx xxxxx xxxxx pneumokokovým xxxxxxxx pro xxxxxxxx x dětském xxxx x u pojištěnců x rizikovými faktory xxxxxxxxxxx xxxxx
&xxxx;

Xxxxxxxxxxxx zdravotnictví xxxxx §30 xxxx. 2 xxxx. x) x x) zákona x. 48/1997 Sb., x veřejném xxxxxxxxxx xxxxxxxxx x o xxxxx x xxxxxxxx xxxxxxxxx xxxxxxxxxxxxx xxxxxx, xx znění xxxxxxxxxx xxxxxxxx, xxxxxxx xxxxxxxxx xxxxxxx očkovacích xxxxx xxx očkování proti xxxxxxxxxxxxx xxxxxxxx v xxxxxxx věku x x pojištěnců s xxxxxxxxxx xxxxxxx zdravotního xxxxx:

1)&xxxx;13xxxxxxxx polysacharidovou xxxxxxxxxxxx xxxxxxxx xxxxx xxxxx xxxxxxxxxxxxx infekcím, xxxxx x jedné dávce (0,5 ml) obsahuje:

Streptococci xxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 1¹&xxxx;2,2 xxxxxxxxxx

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 3¹ 2,2 xxxxxxxxxx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 4¹&xxxx;2,2 xxxxxxxxxx

Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum sérotypus 5¹&xxxx;2,2 xxxxxxxxxx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 6X¹&xxxx;2,2 xxxxxxxxxx

Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum xxxxxxxxx 6X¹&xxxx;4,4 mikrogramů

Streptococci xxxxxxxxxx polysaccharidum sérotypus 7X¹&xxxx;2,2 xxxxxxxxxx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 9X¹&xxxx;2,2 xxxxxxxxxx

Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum xxxxxxxxx 14¹ 2,2 mikrogramů

Streptococci xxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 18X¹&xxxx;2,2 mikrogramů

Streptococci xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 19X¹&xxxx;2,2 xxxxxxxxxx

Xxxxxxxxxxxx pneumoniae polysaccharidum xxxxxxxxx 19X¹&xxxx;2,2 xxxxxxxxxx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 23X¹&xxxx;2,2 xxxxxxxxxx

¹ Xxxxxxxxxx x xxxxxx xxxxxxxxx XXX₁₉₇ x adsorbován xx xxxxxxxxxxx xxxxxxx.

XXXX

2)&xxxx;15xxxxxxxx xxxxxxxxxxxxxxxx xxxxxxxxxxxx očkovací xxxxx proti xxxxxxxxxxxxx xxxxxxxx, xxxxx x xxxxx dávce (0,5 xx) xxxxxxxx:

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 1^1,2 polysaccharidum 2,0 xxxxxxxxxx

Xxxxxxxxxxxx pneumoniae serotypi 3^1,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 4^1,2 polysaccharidum 2,0 mikrogramů

Streptococci xxxxxxxxxx xxxxxxxx 5^1,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 6X^1,2&xxxx;xxxxxxxxxxxxxxx 2,0 mikrogramů

Streptococci xxxxxxxxxx xxxxxxxx 6B^1,2 polysaccharidum 4,0 mikrogramů

Streptococci xxxxxxxxxx xxxxxxxx 7F^1,2 polysaccharidum 2,0 xxxxxxxxxx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 9X^1,2&xxxx;xxxxxxxxxxxxxxx 2,0 mikrogramů

Streptococci xxxxxxxxxx xxxxxxxx 14^1,2 polysaccharidum 2,0 xxxxxxxxxx

Xxxxxxxxxxxx pneumoniae xxxxxxxx 18X^1,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx

Xxxxxxxxxxxx xxxxxxxxxx serotypi 19X^1,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 19X^1,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 22F^1,2 polysaccharidum 2,0 xxxxxxxxxx

Xxxxxxxxxxxx pneumoniae serotypi 23X^1,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx

Xxxxxxxxxxxx xxxxxxxxxx serotypi 33F^1,2 polysaccharidum 2,0 xxxxxxxxxx

¹ Xxxxxxxxxx x xxxxxxxxxxx xxxxxxx XXX₁₉₇. XXX₁₉₇&xxxx;xx xxxxxxxxx xxxxxx xxxxxxxxxxxx toxinu (xxxxxxxxxxxxx z Corynebacterium xxxxxxxxxxx X7) xxxxxxxxxxxxx xxxxxxxxxxxxx x Xxxxxxxxxxx xxxxxxxxxxx.

² Xxxxxxxxxx na xxxxxxxx xxxxxxxxxxx xxxxxxx.

XXXX

3)&xxxx;xxxxxxxx xxxxx xxxxx xxxxxxxxxxxxx xxxxxxxx xxxxxxxxx x xxxxxxxxxx xxxxxxxx:

3x)&xxxx;13xxxxxxxx polysacharidovou xxxxxxxxxxxx xxxxxxxx látku xxxxx pneumokokovým infekcím, xxxxx x jedné xxxxx (0,5 xx) xxxxxxxx:

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 1¹&xxxx;2,2 mikrogramů

Streptococci xxxxxxxxxx polysaccharidum xxxxxxxxx 3¹&xxxx;2,2 xxxxxxxxxx

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx sérotypus 4¹&xxxx;2,2 xxxxxxxxxx

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 5¹ 2,2 mikrogramů

Streptococci xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 6X¹&xxxx;2,2 xxxxxxxxxx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 6X¹&xxxx;4,4 xxxxxxxxxx

Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum xxxxxxxxx 7X¹&xxxx;2,2 xxxxxxxxxx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 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 sérotypus 19X¹&xxxx;2,2 xxxxxxxxxx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 19F¹ 2,2 xxxxxxxxxx

Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum xxxxxxxxx 23X¹&xxxx;2,2 xxxxxxxxxx

¹ Xxxxxxxxxx x xxxxxx xxxxxxxxx XXX₁₉₇&xxxx;x adsorbován xx xxxxxxxxxxx xxxxxxx.

X

3x)&xxxx;23xxxxxxxx xxxxxxxxxxxxxxxx xxxxxxxx látku xxxxx pneumokokovým infekcím, xxxxx x xxxxx xxxxx (0,5 ml) xxxxxxxx:

xx 25 mikrogramech xxxxxxxxxxxxx 23 xxxxxxxxxxxxxx xxxxxxxxxxxxxxxxx xxxxxxxx: 1, 2, 3, 4, 5, 6X, 7X, 8, 9X, 9V, 10X, HA, 12X, 14, 15B, 17F, 18X, 19F, 19X, 20, 22X, 23X, 33X

XXXX

4)&xxxx;xxxxxxxx xxxxx xxxxx xxxxxxxxxxxxx xxxxxxxx xxxxxxxxx x sekvenčním schématu:

4a) 15valentní xxxxxxxxxxxxxxxx konjugovanou xxxxxxxx xxxxx xxxxx xxxxxxxxxxxxx xxxxxxxx, xxxxx x xxxxx xxxxx (0,5 xx) xxxxxxxx:

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 1^1,2 polysaccharidum 2,0 xxxxxxxxxx

Xxxxxxxxxxxx xxxxxxxxxx serotypi 3^1,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx

Xxxxxxxxxxxx xxxxxxxxxx serotypi 4^1,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 5^1,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx

Xxxxxxxxxxxx pneumoniae xxxxxxxx 6X^1,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 6X^1,2&xxxx;xxxxxxxxxxxxxxx 4,0 xxxxxxxxxx

Xxxxxxxxxxxx pneumoniae xxxxxxxx 7X^1,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx

Xxxxxxxxxxxx xxxxxxxxxx serotypi 9X^1,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx

Xxxxxxxxxxxx xxxxxxxxxx serotypi 14^1,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 18X^1,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 19X^1,2&xxxx;xxxxxxxxxxxxxxx 2,0 mikrogramů

Streptococci xxxxxxxxxx serotypu 19F^1,2 polysaccharidum 2,0 mikrogramů

Streptococci xxxxxxxxxx xxxxxxxx 22F^1,2 polysaccharidum 2,0 xxxxxxxxxx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 23X^1,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 33F^1,2 polysaccharidum 2,0 xxxxxxxxxx

¹ Xxxxxxxxxx x xxxxxxxxxxx nosičem XXX₁₉₇. CRM₁₉₇ je netoxická xxxxxx xxxxxxxxxxxx toxinu (xxxxxxxxxxxxx x Xxxxxxxxxxxxxxx xxxxxxxxxxx X7) xxxxxxxxxxxxx xxxxxxxxxxxxx v Xxxxxxxxxxx xxxxxxxxxxx.

² Adsorbován na xxxxxxxx fosforečnan xxxxxxx.

X

4x)&xxxx;23xxxxxxxx xxxxxxxxxxxxxxxx xxxxxxxx xxxxx xxxxx xxxxxxxxxxxxx xxxxxxxx, xxxxx x xxxxx xxxxx (0,5 xx) xxxxxxxx:

xx 25 mikrogramech xxxxxxxxxxxxx 23 pneumokokových xxxxxxxxxxxxxxxxx xxxxxxxx: 1, 2, 3, 4, 5, 6X, 7F, 8, 9N, 9X, 10X, XX, 12X, 14, 15X, 17X, 18X, 19F, 19X, 20, 22X, 23X, 33X

XXXX

5)&xxxx;20xxxxxxxx polysacharidovou konjugovanou xxxxxxxx xxxxx xxxxx xxxxxxxxxxxxx infekcím, xxxxx x xxxxx xxxxx (0,5 ml) xxxxxxxx:

Xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Streptococcus xxxxxxxxxx sérotypů 1^1,2&xxxx;2,2 xxxxxxxxxx

xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 3^1,2&xxxx;2,2 xxxxxxxxxx

xxxxxxxxxxxx bakterie (xxxxxxxxxx) Xxxxxxxxxxxxx pneumoniae xxxxxxxx 4^1,2&xxxx;2,2 xxxxxxxxxx

xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 5^1,2&xxxx;2,2 xxxxxxxxxx

xxxxxxxxxxxx bakterie (xxxxxxxxxx) Xxxxxxxxxxxxx pneumoniae sérotypů 6X^1,2&xxxx;2,2 xxxxxxxxxx

xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Streptococcus pneumoniae xxxxxxxx 6X^1,2&xxxx;4,4 mikrogramů

polysacharid xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx sérotypů 7X^1,2&xxxx;2,2 xxxxxxxxxx

xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 8^1,2&xxxx;2,2 xxxxxxxxxx

xxxxxxxxxxxx bakterie (xxxxxxxxxx) Streptococcus xxxxxxxxxx xxxxxxxx 9X^1,2&xxxx;2,2 xxxxxxxxxx

xxxxxxxxxxxx xxxxxxxx (pneumokoka) Streptococcus xxxxxxxxxx sérotypu 10X^1,2&xxxx;2,2 xxxxxxxxxx

xxxxxxxxxxxx bakterie (pneumokoka) Xxxxxxxxxxxxx pneumoniae sérotypu 11 X^1,2&xxxx;2,2 mikrogramů

polysacharid xxxxxxxx (pneumokoka) Streptococcus xxxxxxxxxx xxxxxxxx 12X^1,2&xxxx;2,2 xxxxxxxxxx

xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 14^1,2&xxxx;2,2 mikrogramů

polysacharid bakterie (xxxxxxxxxx) Streptococcus xxxxxxxxxx xxxxxxxx 15X^1,2&xxxx;2,2 xxxxxxxxxx

xxxxxxxxxxxx xxxxxxxx (pneumokoka) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 18C^1,2 2,2 xxxxxxxxxx

xxxxxxxxxxxx bakterie (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 19X^1,2&xxxx;2,2 mikrogramů

polysacharid bakterie (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 19X^1,2&xxxx;2,2 mikrogramů

polysacharid xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 22X^1,2&xxxx;2,2 xxxxxxxxxx

xxxxxxxxxxxx bakterie (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 23X^1,2&xxxx;2,2 xxxxxxxxxx

xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Streptococcus pneumoniae xxxxxxxx 33F^1,2 2,2 xxxxxxxxxx

¹ Xxxxxxxxxx x nosným xxxxxxxxx CRM₁₉₇ (xxxxxxxxx 51 μg na xxxxx).

² Adsorbován xx xxxxxxxxxxx hlinitý (0,125 xx xxxxxxx xx xxxxx).
&xxxx;

Xxxxxxx:

xxxx. XXXx. Válek, XXx, XXX, XXXX, x. x.

Xxxxxxxxx

Xxxxxx xxxxxxx x. 23/2024 Xx. xxxxx xxxxxxxxx xxxx 8.2.2024.

Xx xxx uzávěrky právní xxxxxxx xxxxx xxxxx xx doplňován.

Znění jednotlivých xxxxxxxx xxxxx jiných xxxxxxxx xxxxxxxx x xxxxxxxx není xxxxxxxxxxxxx, xxxxx xx xxxx xxxxxx xxxxxxxxx změna xxxxx uvedeného právního xxxxxxxx.