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 dne 29. xxxxx 2024

o xxxxxxxxxx xxxxxxx xxxxxxxxxx xxxxx xxxxx pneumokokovým xxxxxxxx pro xxxxxxxx x xxxxxxx xxxx x x pojištěnců x rizikovými faktory xxxxxxxxxxx xxxxx
&xxxx;

Xxxxxxxxxxxx xxxxxxxxxxxxx xxxxx §30 odst. 2 xxxx. j) x k) zákona x. 48/1997 Xx., x xxxxxxxx zdravotním xxxxxxxxx x x xxxxx x doplnění xxxxxxxxx souvisejících xxxxxx, xx xxxxx xxxxxxxxxx xxxxxxxx, xxxxxxx xxxxxxxxx xxxxxxx xxxxxxxxxx látek xxx xxxxxxxx xxxxx xxxxxxxxxxxxx xxxxxxxx x xxxxxxx věku x x xxxxxxxxxx x xxxxxxxxxx xxxxxxx zdravotního xxxxx:

1)&xxxx;13xxxxxxxx polysacharidovou xxxxxxxxxxxx xxxxxxxx xxxxx proti xxxxxxxxxxxxx xxxxxxxx, xxxxx x jedné xxxxx (0,5 xx) xxxxxxxx:

Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum sérotypus 1¹&xxxx;2,2 mikrogramů

Streptococci xxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 3¹&xxxx;2,2 xxxxxxxxxx

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

Streptococci xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 5¹&xxxx;2,2 xxxxxxxxxx

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

Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum xxxxxxxxx 6B¹ 4,4 xxxxxxxxxx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 7X¹&xxxx;2,2 xxxxxxxxxx

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

Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum xxxxxxxxx 14¹ 2,2 xxxxxxxxxx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 18X¹&xxxx;2,2 xxxxxxxxxx

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

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

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

¹ Konjugován x nosným proteinem XXX₁₉₇ x adsorbován xx xxxxxxxxxxx xxxxxxx.

XXXX

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

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

Xxxxxxxxxxxx pneumoniae xxxxxxxx 3^1,2&xxxx;xxxxxxxxxxxxxxx 2,0 mikrogramů

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

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

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

Streptococci xxxxxxxxxx xxxxxxxx 14^1,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx

Xxxxxxxxxxxx pneumoniae xxxxxxxx 18C^1,2 polysaccharidum 2,0 xxxxxxxxxx

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

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

Xxxxxxxxxxxx pneumoniae xxxxxxxx 22X^1,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx

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

Streptococci xxxxxxxxxx serotypi 33X^1,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx

¹ Konjugován x proteinovým xxxxxxx XXX₁₉₇. CRM₁₉₇ je xxxxxxxxx xxxxxx xxxxxxxxxxxx xxxxxx (xxxxxxxxxxxxx x Xxxxxxxxxxxxxxx xxxxxxxxxxx X7) rekombinantně xxxxxxxxxxxxx v Xxxxxxxxxxx xxxxxxxxxxx.

² Xxxxxxxxxx xx xxxxxxxx xxxxxxxxxxx hlinitý.

NEBO

3) očkovací xxxxx xxxxx pneumokokovým xxxxxxxx xxxxxxxxx x xxxxxxxxxx xxxxxxxx:

3x)&xxxx;13xxxxxxxx xxxxxxxxxxxxxxxx xxxxxxxxxxxx očkovací xxxxx xxxxx xxxxxxxxxxxxx infekcím, xxxxx x xxxxx xxxxx (0,5 xx) xxxxxxxx:

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

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

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

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 5¹ 2,2 mikrogramů

Streptococci xxxxxxxxxx polysaccharidum xxxxxxxxx 6X¹&xxxx;2,2 mikrogramů

Streptococci xxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 6X¹&xxxx;4,4 xxxxxxxxxx

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

Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum xxxxxxxxx 9X¹&xxxx;2,2 mikrogramů

Streptococci xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 14¹&xxxx;2,2 xxxxxxxxxx

Xxxxxxxxxxxx pneumoniae polysaccharidum xxxxxxxxx 18X¹&xxxx;2,2 xxxxxxxxxx

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

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 19F¹ 2,2 xxxxxxxxxx

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

¹ Xxxxxxxxxx x xxxxxx xxxxxxxxx XXX₁₉₇&xxxx;x xxxxxxxxxx xx fosforečnan hlinitý.

A

3b) 23valentní xxxxxxxxxxxxxxxx očkovací xxxxx xxxxx pneumokokovým xxxxxxxx, xxxxx x jedné xxxxx (0,5 xx) xxxxxxxx:

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

XXXX

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

4x)&xxxx;15xxxxxxxx xxxxxxxxxxxxxxxx xxxxxxxxxxxx xxxxxxxx xxxxx proti pneumokokovým xxxxxxxx, která x xxxxx xxxxx (0,5 xx) xxxxxxxx:

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

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

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

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

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

Xxxxxxxxxxxx xxxxxxxxxx serotypi 6B^1,2 polysaccharidum 4,0 xxxxxxxxxx

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

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

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

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

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

Streptococci xxxxxxxxxx serotypu 19X^1,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx

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

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

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

¹ Xxxxxxxxxx x proteinovým nosičem XXX₁₉₇. XXX₁₉₇&xxxx;xx xxxxxxxxx xxxxxx difterického toxinu (xxxxxxxxxxxxx z Xxxxxxxxxxxxxxx xxxxxxxxxxx X7) xxxxxxxxxxxxx xxxxxxxxxxxxx x Xxxxxxxxxxx xxxxxxxxxxx.

² Xxxxxxxxxx na xxxxxxxx fosforečnan xxxxxxx.

X

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

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

XXXX

5)&xxxx;20xxxxxxxx xxxxxxxxxxxxxxxx xxxxxxxxxxxx xxxxxxxx látku proti xxxxxxxxxxxxx xxxxxxxx, xxxxx x xxxxx xxxxx (0,5 xx) obsahuje:

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

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

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

polysacharid xxxxxxxx (pneumokoka) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 5^1,2 2,2 xxxxxxxxxx

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

xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Streptococcus pneumoniae xxxxxxxx 6B^1,2 4,4 xxxxxxxxxx

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

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

polysacharid xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 9V^1,2 2,2 xxxxxxxxxx

xxxxxxxxxxxx xxxxxxxx (pneumokoka) Streptococcus xxxxxxxxxx sérotypu 10A^1,2 2,2 xxxxxxxxxx

xxxxxxxxxxxx bakterie (xxxxxxxxxx) Xxxxxxxxxxxxx pneumoniae xxxxxxxx 11 X^1,2&xxxx;2,2 xxxxxxxxxx

xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 12F^1,2 2,2 xxxxxxxxxx

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

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

xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Streptococcus xxxxxxxxxx sérotypu 18C^1,2 2,2 xxxxxxxxxx

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

polysacharid xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx pneumoniae xxxxxxxx 19F^1,2 2,2 xxxxxxxxxx

xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Streptococcus xxxxxxxxxx xxxxxxxx 22F^1,2 2,2 xxxxxxxxxx

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

polysacharid xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 33X^1,2&xxxx;2,2 mikrogramů

¹ Xxxxxxxxxx x nosným xxxxxxxxx CRM₁₉₇ (xxxxxxxxx 51 μx xx xxxxx).

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

Xxxxxxx:

xxxx. MUDr. Xxxxx, XXx, XXX, XXXX, x. x.

Xxxxxxxxx

Xxxxxx xxxxxxx č. 23/2024 Xx. nabyl xxxxxxxxx dnem 8.2.2024.

Xx xxx uzávěrky právní xxxxxxx nebyl měněn xx xxxxxxxxx.

Xxxxx xxxxxxxxxxxx xxxxxxxx xxxxx jiných xxxxxxxx xxxxxxxx v xxxxxxxx xxxx xxxxxxxxxxxxx, xxxxx xx xxxx xxxxxx xxxxxxxxx xxxxx xxxxx xxxxxxxxx xxxxxxxx xxxxxxxx.