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. xxxxx 2024

x xxxxxxxxxx xxxxxxx xxxxxxxxxx xxxxx proti pneumokokovým xxxxxxxx pro očkování x xxxxxxx xxxx x x xxxxxxxxxx x xxxxxxxxxx faktory xxxxxxxxxxx stavu
 

Ministerstvo zdravotnictví xxxxx §30 odst. 2 xxxx. j) x x) xxxxxx x. 48/1997 Xx., x veřejném xxxxxxxxxx xxxxxxxxx x x xxxxx x xxxxxxxx xxxxxxxxx xxxxxxxxxxxxx xxxxxx, xx znění pozdějších xxxxxxxx, stanoví antigenní xxxxxxx očkovacích xxxxx xxx xxxxxxxx xxxxx xxxxxxxxxxxxx xxxxxxxx x xxxxxxx xxxx a x xxxxxxxxxx x xxxxxxxxxx xxxxxxx zdravotního xxxxx:

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

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

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 3¹ 2,2 xxxxxxxxxx

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 4¹ 2,2 xxxxxxxxxx

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

Streptococci xxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 6A¹ 2,2 xxxxxxxxxx

Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum xxxxxxxxx 6B¹ 4,4 mikrogramů

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

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 9V¹ 2,2 xxxxxxxxxx

Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum xxxxxxxxx 14¹ 2,2 mikrogramů

Streptococci xxxxxxxxxx polysaccharidum sérotypus 18X¹&xxxx;2,2 xxxxxxxxxx

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

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

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

¹ Konjugován x xxxxxx xxxxxxxxx XXX₁₉₇ a xxxxxxxxxx xx fosforečnan xxxxxxx.

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

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

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

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

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

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

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

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

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

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

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

Xxxxxxxxxxxx xxxxxxxxxx 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. CRM₁₉₇ je xxxxxxxxx xxxxxx xxxxxxxxxxxx xxxxxx (xxxxxxxxxxxxx x Xxxxxxxxxxxxxxx xxxxxxxxxxx X7) rekombinantně xxxxxxxxxxxxx x Xxxxxxxxxxx xxxxxxxxxxx.

² Adsorbován na xxxxxxxx fosforečnan hlinitý.

NEBO

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

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

Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum xxxxxxxxx 1¹ 2,2 xxxxxxxxxx

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

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

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

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 6X¹&xxxx;2,2 mikrogramů

Streptococci xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 6B¹ 4,4 xxxxxxxxxx

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

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

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

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 18C¹ 2,2 xxxxxxxxxx

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

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

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

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

X

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

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

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

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

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

Xxxxxxxxxxxx pneumoniae xxxxxxxx 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 polysaccharidum 2,0 xxxxxxxxxx

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

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

Xxxxxxxxxxxx xxxxxxxxxx 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 mikrogramů

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

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

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

¹ Xxxxxxxxxx x xxxxxxxxxxx nosičem XXX₁₉₇. CRM₁₉₇ je xxxxxxxxx xxxxxx xxxxxxxxxxxx xxxxxx (xxxxxxxxxxxxx x Xxxxxxxxxxxxxxx xxxxxxxxxxx C7) xxxxxxxxxxxxx xxxxxxxxxxxxx v Pseudomonas xxxxxxxxxxx.

² Adsorbován na xxxxxxxx fosforečnan xxxxxxx.

X

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

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

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

Polysacharid xxxxxxxx (pneumokoka) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 1^1,2 2,2 xxxxxxxxxx

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

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

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

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

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

polysacharid xxxxxxxx (pneumokoka) Streptococcus xxxxxxxxxx xxxxxxxx 7F^1,2 2,2 xxxxxxxxxx

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

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

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

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

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

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

xxxxxxxxxxxx bakterie (xxxxxxxxxx) Xxxxxxxxxxxxx pneumoniae xxxxxxxx 15X^1,2&xxxx;2,2 mikrogramů

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

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

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

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

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

polysacharid xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx pneumoniae xxxxxxxx 33F^1,2 2,2 mikrogramů

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

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

Xxxxxxx:

xxxx. MUDr. Xxxxx, XXx, MBA, XXXX, x. r.

Xxxxxxxxx

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

Xx xxx uzávěrky xxxxxx xxxxxxx nebyl měněn xx xxxxxxxxx.

Xxxxx jednotlivých xxxxxxxx xxxxx xxxxxx xxxxxxxx xxxxxxxx v xxxxxxxx není xxxxxxxxxxxxx, xxxxx se jich xxxxxx xxxxxxxxx xxxxx xxxxx xxxxxxxxx xxxxxxxx xxxxxxxx.