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 xxxxxxx xxxxxxxxxx xxxxx proti xxxxxxxxxxxxx xxxxxxxx xxx očkování x xxxxxxx xxxx x x pojištěnců x rizikovými xxxxxxx xxxxxxxxxxx xxxxx
&xxxx;

Xxxxxxxxxxxx xxxxxxxxxxxxx xxxxx §30 xxxx. 2 xxxx. x) x k) xxxxxx x. 48/1997 Xx., x veřejném xxxxxxxxxx xxxxxxxxx a o xxxxx x xxxxxxxx xxxxxxxxx souvisejících zákonů, xx xxxxx pozdějších xxxxxxxx, stanoví xxxxxxxxx xxxxxxx xxxxxxxxxx xxxxx xxx xxxxxxxx xxxxx xxxxxxxxxxxxx xxxxxxxx v xxxxxxx xxxx x x xxxxxxxxxx x xxxxxxxxxx faktory xxxxxxxxxxx xxxxx:

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

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

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 3¹ 2,2 xxxxxxxxxx

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

Streptococci xxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 5¹&xxxx;2,2 mikrogramů

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

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 6B¹ 4,4 xxxxxxxxxx

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

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 9V¹ 2,2 xxxxxxxxxx

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 14¹&xxxx;2,2 xxxxxxxxxx

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

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

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 19F¹ 2,2 xxxxxxxxxx

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

¹ Xxxxxxxxxx x xxxxxx xxxxxxxxx XXX₁₉₇ a xxxxxxxxxx xx xxxxxxxxxxx hlinitý.

NEBO

2) 15valentní xxxxxxxxxxxxxxxx xxxxxxxxxxxx xxxxxxxx xxxxx xxxxx xxxxxxxxxxxxx xxxxxxxx, xxxxx x xxxxx xxxxx (0,5 xx) obsahuje:

Streptococci 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&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx

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

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

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

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

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

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

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

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

Xxxxxxxxxxxx xxxxxxxxxx serotypu 19F^1,2 polysaccharidum 2,0 xxxxxxxxxx

Xxxxxxxxxxxx xxxxxxxxxx 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 mikrogramů

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

² Adsorbován na xxxxxxxx xxxxxxxxxxx xxxxxxx.

XXXX

3)&xxxx;xxxxxxxx xxxxx xxxxx pneumokokovým xxxxxxxx xxxxxxxxx x xxxxxxxxxx schématu:

3a) 13valentní polysacharidovou xxxxxxxxxxxx xxxxxxxx látku xxxxx xxxxxxxxxxxxx infekcím, xxxxx x jedné xxxxx (0,5 xx) xxxxxxxx:

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

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 3¹&xxxx;2,2 xxxxxxxxxx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 4¹ 2,2 xxxxxxxxxx

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

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

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

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 7F¹ 2,2 mikrogramů

Streptococci xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 9X¹&xxxx;2,2 xxxxxxxxxx

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx sérotypus 14¹&xxxx;2,2 xxxxxxxxxx

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 18C¹ 2,2 xxxxxxxxxx

Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum xxxxxxxxx 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 x xxxxxx xxxxxxxxx CRM₁₉₇ a xxxxxxxxxx xx xxxxxxxxxxx xxxxxxx.

X

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

xx 25 xxxxxxxxxxxx xxxxxxxxxxxxx 23 xxxxxxxxxxxxxx xxxxxxxxxxxxxxxxx xxxxxxxx: 1, 2, 3, 4, 5, 6X, 7F, 8, 9X, 9V, 10X, HA, 12X, 14, 15B, 17F, 18X, 19X, 19X, 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, která v xxxxx xxxxx (0,5 xx) obsahuje:

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

Xxxxxxxxxxxx xxxxxxxxxx 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 polysaccharidum 2,0 xxxxxxxxxx

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

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

Xxxxxxxxxxxx xxxxxxxxxx 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 polysaccharidum 2,0 xxxxxxxxxx

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

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

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 19F^1,2 polysaccharidum 2,0 xxxxxxxxxx

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

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

Streptococci xxxxxxxxxx serotypi 33F^1,2 polysaccharidum 2,0 mikrogramů

¹ Konjugován x proteinovým nosičem XXX₁₉₇. CRM₁₉₇ je netoxická xxxxxx xxxxxxxxxxxx xxxxxx (xxxxxxxxxxxxx z Corynebacterium xxxxxxxxxxx C7) xxxxxxxxxxxxx xxxxxxxxxxxxx v Pseudomonas xxxxxxxxxxx.

² Adsorbován na xxxxxxxx xxxxxxxxxxx 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, 6X, 7X, 8, 9N, 9V, 10X, XX, 12X, 14, 15X, 17X, 18X, 19X, 19A, 20, 22X, 23F, 33X

XXXX

5)&xxxx;20xxxxxxxx xxxxxxxxxxxxxxxx konjugovanou xxxxxxxx xxxxx proti xxxxxxxxxxxxx xxxxxxxx, která x xxxxx dávce (0,5 xx) xxxxxxxx:

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

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

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

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

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

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

xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 7F^1,2 2,2 xxxxxxxxxx

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

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

xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 10X^1,2&xxxx;2,2 xxxxxxxxxx

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

xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 12X^1,2&xxxx;2,2 xxxxxxxxxx

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

polysacharid xxxxxxxx (xxxxxxxxxx) Streptococcus pneumoniae xxxxxxxx 15B^1,2 2,2 xxxxxxxxxx

xxxxxxxxxxxx xxxxxxxx (pneumokoka) Streptococcus xxxxxxxxxx xxxxxxxx 18X^1,2&xxxx;2,2 xxxxxxxxxx

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

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

xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx sérotypu 22F^1,2 2,2 xxxxxxxxxx

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

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

¹ Xxxxxxxxxx x xxxxxx xxxxxxxxx XXX₁₉₇ (xxxxxxxxx 51 μx xx xxxxx).

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

Xxxxxxx:

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

Informace

Právní předpis x. 23/2024 Xx. xxxxx xxxxxxxxx xxxx 8.2.2024.

Ke xxx uzávěrky xxxxxx xxxxxxx xxxxx xxxxx xx xxxxxxxxx.

Xxxxx jednotlivých xxxxxxxx norem jiných xxxxxxxx xxxxxxxx v xxxxxxxx xxxx xxxxxxxxxxxxx, xxxxx xx xxxx xxxxxx xxxxxxxxx xxxxx xxxxx uvedeného xxxxxxxx xxxxxxxx.