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

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Xxxxxxxxxxxx xxxxxxxxxxxxx

xx xxx 29. ledna 2024

x xxxxxxxxxx složení xxxxxxxxxx xxxxx proti xxxxxxxxxxxxx xxxxxxxx xxx xxxxxxxx x xxxxxxx xxxx x u xxxxxxxxxx x xxxxxxxxxx xxxxxxx xxxxxxxxxxx stavu
 

Ministerstvo xxxxxxxxxxxxx xxxxx §30 odst. 2 xxxx. x) x x) zákona x. 48/1997 Xx., x veřejném xxxxxxxxxx xxxxxxxxx a o xxxxx x doplnění xxxxxxxxx xxxxxxxxxxxxx xxxxxx, xx xxxxx xxxxxxxxxx xxxxxxxx, xxxxxxx xxxxxxxxx xxxxxxx očkovacích xxxxx xxx xxxxxxxx proti xxxxxxxxxxxxx xxxxxxxx x xxxxxxx věku x x pojištěnců s xxxxxxxxxx xxxxxxx xxxxxxxxxxx xxxxx:

1)&xxxx;13xxxxxxxx xxxxxxxxxxxxxxxx konjugovanou xxxxxxxx látku xxxxx xxxxxxxxxxxxx infekcím, která x jedné xxxxx (0,5 ml) xxxxxxxx:

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

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

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 4¹ 2,2 mikrogramů

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

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 6A¹ 2,2 xxxxxxxxxx

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

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

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 9V¹ 2,2 xxxxxxxxxx

Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum xxxxxxxxx 14¹&xxxx;2,2 mikrogramů

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

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

Xxxxxxxxxxxx pneumoniae polysaccharidum xxxxxxxxx 19F¹ 2,2 mikrogramů

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

¹ Xxxxxxxxxx x nosným xxxxxxxxx XXX₁₉₇ x xxxxxxxxxx xx xxxxxxxxxxx hlinitý.

NEBO

2) 15valentní xxxxxxxxxxxxxxxx konjugovanou očkovací xxxxx proti xxxxxxxxxxxxx xxxxxxxx, která x xxxxx xxxxx (0,5 xx) xxxxxxxx:

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

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

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

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

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

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

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

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

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 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 xxxxxxxxxx

Xxxxxxxxxxxx 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 xxxxxxxxxx

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

¹ Xxxxxxxxxx x proteinovým xxxxxxx XXX₁₉₇. CRM₁₉₇ je netoxická xxxxxx difterického xxxxxx (xxxxxxxxxxxxx z Corynebacterium xxxxxxxxxxx C7) xxxxxxxxxxxxx xxxxxxxxxxxxx x Xxxxxxxxxxx xxxxxxxxxxx.

² Xxxxxxxxxx na xxxxxxxx xxxxxxxxxxx hlinitý.

NEBO

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

3a) 13valentní xxxxxxxxxxxxxxxx xxxxxxxxxxxx xxxxxxxx xxxxx xxxxx xxxxxxxxxxxxx infekcím, xxxxx x jedné xxxxx (0,5 ml) xxxxxxxx:

Xxxxxxxxxxxx pneumoniae polysaccharidum xxxxxxxxx 1¹&xxxx;2,2 xxxxxxxxxx

Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum sérotypus 3¹&xxxx;2,2 xxxxxxxxxx

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

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 5¹ 2,2 xxxxxxxxxx

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

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

Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum xxxxxxxxx 7F¹ 2,2 mikrogramů

Streptococci xxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 9X¹&xxxx;2,2 mikrogramů

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

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 18C¹ 2,2 mikrogramů

Streptococci xxxxxxxxxx polysaccharidum sérotypus 19X¹&xxxx;2,2 xxxxxxxxxx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 19F¹ 2,2 xxxxxxxxxx

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

¹ Xxxxxxxxxx s nosným xxxxxxxxx CRM₁₉₇ a adsorbován xx xxxxxxxxxxx hlinitý.

A

3b) 23valentní xxxxxxxxxxxxxxxx očkovací xxxxx xxxxx xxxxxxxxxxxxx xxxxxxxx, xxxxx v xxxxx xxxxx (0,5 xx) xxxxxxxx:

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

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4)&xxxx;xxxxxxxx látky xxxxx xxxxxxxxxxxxx xxxxxxxx používané x xxxxxxxxxx xxxxxxxx:

4x)&xxxx;15xxxxxxxx xxxxxxxxxxxxxxxx xxxxxxxxxxxx xxxxxxxx xxxxx xxxxx pneumokokovým xxxxxxxx, xxxxx v xxxxx dávce (0,5 xx) obsahuje:

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

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

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

Streptococci xxxxxxxxxx xxxxxxxx 5^1,2 polysaccharidum 2,0 xxxxxxxxxx

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

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

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

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

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

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 33X^1,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx

¹ Xxxxxxxxxx x xxxxxxxxxxx xxxxxxx XXX₁₉₇. XXX₁₉₇&xxxx;xx xxxxxxxxx xxxxxx xxxxxxxxxxxx toxinu (xxxxxxxxxxxxx z Corynebacterium xxxxxxxxxxx C7) rekombinantně xxxxxxxxxxxxx x Xxxxxxxxxxx xxxxxxxxxxx.

² Xxxxxxxxxx xx xxxxxxxx fosforečnan hlinitý.

A

4b) 23valentní xxxxxxxxxxxxxxxx xxxxxxxx látku xxxxx xxxxxxxxxxxxx xxxxxxxx, xxxxx x jedné xxxxx (0,5 xx) xxxxxxxx:

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

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5)&xxxx;20xxxxxxxx polysacharidovou xxxxxxxxxxxx xxxxxxxx látku xxxxx xxxxxxxxxxxxx xxxxxxxx, xxxxx x jedné dávce (0,5 xx) obsahuje:

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

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

polysacharid xxxxxxxx (xxxxxxxxxx) Streptococcus pneumoniae xxxxxxxx 4^1,2&xxxx;2,2 xxxxxxxxxx

xxxxxxxxxxxx xxxxxxxx (pneumokoka) Streptococcus xxxxxxxxxx xxxxxxxx 5^1,2 2,2 xxxxxxxxxx

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

xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 6X^1,2&xxxx;4,4 xxxxxxxxxx

xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Streptococcus xxxxxxxxxx sérotypů 7F^1,2 2,2 xxxxxxxxxx

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

polysacharid xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx pneumoniae xxxxxxxx 9X^1,2&xxxx;2,2 xxxxxxxxxx

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

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

xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Streptococcus xxxxxxxxxx sérotypu 12F^1,2 2,2 xxxxxxxxxx

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

polysacharid xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 15B^1,2 2,2 xxxxxxxxxx

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

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

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

xxxxxxxxxxxx xxxxxxxx (pneumokoka) Streptococcus xxxxxxxxxx xxxxxxxx 22X^1,2&xxxx;2,2 xxxxxxxxxx

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

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

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

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

Xxxxxxx:

xxxx. XXXx. Xxxxx, XXx, MBA, EBIR, x. x.

Xxxxxxxxx

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

Ke xxx uzávěrky xxxxxx xxxxxxx xxxxx xxxxx xx xxxxxxxxx.

Xxxxx xxxxxxxxxxxx xxxxxxxx norem xxxxxx xxxxxxxx xxxxxxxx x xxxxxxxx není xxxxxxxxxxxxx, xxxxx xx jich xxxxxx derogační xxxxx xxxxx xxxxxxxxx právního xxxxxxxx.