Plné znění - 528/2025 Sb.

Sdělení Ministerstva zdravotnictví o antigenním složení očkovacích látek pro pravidelná, zvláštní a mimořádná očkování pro rok 2026

528/2025 Sb.
 

Sdělení Ministerstva zdravotnictví

INFORMACE

528

SDĚLENÍ

Ministerstva xxxxxxxxxxxxx

xx dne 10. xxxxxxxx 2025

x xxxxxxxxxx složení xxxxxxxxxx xxxxx pro xxxxxxxxxx, xxxxxxxx x mimořádná xxxxxxxx xxx xxx 2026
&xxxx;

Xxxxxxxxxxxx xxxxxxxxxxxxx xxxxx §80 xxxx. 1 xxxx. x) zákona x. 258/2000 Sb., x xxxxxxx xxxxxxxxx xxxxxx x x xxxxx xxxxxxxxx xxxxxxxxxxxxx xxxxxx, xx xxxxx xxxxxxxxxx xxxxxxxx, xxxxxxx xx xxxxxxx xxxxxxxxxx Xxxxxxx imunizační komise xxxxxxxxx složení očkovacích xxxxx pro xxxxxxxxxx, xxxxxxxx x xxxxxxxxx xxxxxxxx xxx xxx 2026:

1.&xxxx;Xxxxxxxxx složení očkovacích xxxxx xxx xxxxxxxxxx xxxxxxxx

1x) kombinovaná očkovací látka xxxxx záškrtu, dávivému xxxxx (xxxxxxxxxx xxxxx), xxxxxx, dětské xxxxxxxx xxxxx (inaktivovaná xxxxx), xxxxxx xxxxxxxxxx X, xxxxxxx xxxxxxxxx Haemophilus xxxxxxxxxx xxx b (XXxXXxxXXXXXX)

Xx xxxxxxxxxxxx 1 xxxxx (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx xxxxxxxxxx¹&xxxx;xx méně xxx 30 xxxxxxxxxxxxx xxxxxxxx (IU)

Tetani anatoxinum¹ ne xxxx xxx 40 xxxxxxxxxxxxx jednotek (XX)

Xxxxxxxx&xxxx;Xxxxxxxxxx xxxxxxxxx:

Xxxxxxxxx xxxxxxxxxx (PT)¹ 25 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxxxx xxxxxxxxxxxx (XXX)¹&xxxx;25 mikrogramů

Pertactinum (XXX)¹&xxxx;8 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx X (HBs)^2,3 10 xxxxxxxxxx

Xxxxx xxxxxxxxxxxxxxx inactivatum (IPV)

typus 1 (xxxx Xxxxxxx)^4&xxxx;40 X xxxxxxxx xxxxxxxx

xxxxx 2 (xxxx XXX-1)⁴&xxxx;8 X xxxxxxxx xxxxxxxx

xxxxx 3 (xxxx Xxxxxxx)⁴&xxxx;32 X xxxxxxxx xxxxxxxx

Xxxxxxxxxxx xxxxxxxxxx xxxxx&xxxx;x xxxxxxxxxxxxxxx

(Xxxxxxxxxxxxxxxxxxx xxxxxxxx) 10 xxxxxxxxxx

xxxx. xxx xxxxxx. xxxxxxxx xxxx xxxxx xxxxxxx xxxxxxxxx 25 xxxxxxxxxx

¹&xxxx;xxxxxxxxxxx xx xxxxxxxx xxxxxxx, xxxxxxxxxxx (Xx(XX)₃) 0,5 xxxxxxxxx Al³⁺

² vyrobeno xxxxxxxxxxxxx XXX xxxxxxxxxxx na xxxxxxx xxxxxxxxxxxx buněk (Xxxxxxxxxxxxx xxxxxxxxxx)

³&xxxx;xxxxxxxxxxx xx xxxxxxxxxxx xxxxxxx (XxXX₄) 0,32 miligramů Xx³⁺

⁴&xxxx;xxxxxxxxx xx XXXX buňkách

NEBO

1aa) kombinovaná xxxxxxxx xxxxx proti xxxxxxx, xxxxxxxx kašli (xxxxxxxxxx forma), tetanu, xxxxxx přenosné xxxxx (xxxxxxxxxxxx xxxxx), xxxxxx xxxxxxxxxx X, xxxxxxx xxxxxxxxx Xxxxxxxxxxx xxxxxxxxxx xxx x (XXxXXxxXXXXXX)

Xxxxx xxxxx¹&xxxx;(0,5 xx) xxxxxxxx:

Xxxxxxxxxxx xxxxxxxxxx xx xxxx xxx 20 xxxxxxxxxxxxx xxxxxxxx (XX)^2,4&xxxx;(30 Xx)

Xxxxxx xxxxxxxxxx xx xxxx xxx 40 xxxxxxxxxxxxx xxxxxxxx (XX)^3,4&xxxx;(10 Xx)

Xxxxxxxx Xxxxxxxxxx xxxxxxxxx

Xxxxxxxxx xxxxxxxxxx 25 xxxxxxxxxx

Xxxxxxxxx haemagglutininum xxxxxxxxxxxx 25 xxxxxxxxxx

Xxxxx Xxxxxxxxxxxxxxx (xxxxxxxxxxxx)⁵

xxxxx 1 (Xxxxxxx) 29 X xxxxxxxx xxxxxxxx⁶

xxxxx 2 (XXX-1) 7 X xxxxxxxx xxxxxxxx⁶

xxxxx 3 (Xxxxxxx) 26 D xxxxxxxx xxxxxxxx⁶

Xxxxxxxxx xxxxxxxxxxx X antigenum⁷ 10 mikrogramů

Haemophili xxxxxxxxxx xxxx X xxxxxxxxxxxxxxx (Xxxxxxxxxxxxxxxxxxx phosphas) 12 mikrogramů

coniugatum xxx xxxxxx xxxxxxxx 22-36 xxxxxxxxxx

^1&xxxx;Xxxxxxxxxxx xx xxxxxxxxxxx xxxxxxxx hlinitý (0,6 xx Xx³⁺)

²&xxxx;Xxxx xxxxxx xxx spolehlivosti (p = 0,95) x xx xxxx xxx 30 XX xxxx xxxxxxx hodnota

³ Jako xxxxxx xxx xxxxxxxxxxxxx (x = 0,95)

⁴&xxxx;Xxxx xxxxxxxxxxxx xxxxxxxx xxxxxxxxx xxxxxxxxxx xxxxxxxxxxx

^5&xxxx;Xxxxxxxxxxx xx Xxxx xxxxxxx

^6&xxxx;Xxxx xxxxxxxx xxxxxxxx xxxx xxxxx xxxxxx xxxx xx, která xxxx dříve vyjádřená xxxx 40-8-32 X xxxxxxxx xxxxxxxx xxx xxxxx typu 1, 2 x 3, xxx měření xxxxx xxxxxxx xxxxxxxxxxxxxx xxxxxxx.

⁷&xxxx;xxxxxxxx xxxxxxxxxxxxx DNA xxxxxxxxxxx x xxxxxxxxxxxx xxxxxxx Xxxxxxxxx xxxxxxxxxx

XXXX

1xx) Xxxxxxx xxxxx záškrtu, xxxxxx, xxxxxxxx kašli (xxxxxxxxxx xxxxxxxxxx), xxxxxxxxxx B (xXXX), xxxxxx přenosné xxxxx (xxxxxxxxxxxx) x xxxxxxxxxxx xxxxxxx proti Xxxxxxxxxxx xxxx b (xxxxxxxxxxx)

Xxxxx xxxxx (0,5 xx) obsahuje:

Diphtheriae anatoxinum¹ xx méně xxx 20 XX⁶

Xxxxxx anatoxinumˡ xx méně než 40 XX⁶

Xxxxxxxx&xxxx;Xxxxxxxxxxx xxxxxxxx¹

Xxxxxxxxx xxxxxxxxxx (XX) 20 xxxxxxxxxx

Xxxxxxxxxxxxxxx filamentosum (XXX) 20 xxxxxxxxxx

Xxxxxxxxxxx (PRN) 3 xxxxxxxxxx

Xxxxxxxx xxxx 2 xx 3 (XXX) 5 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx X^2,3&xxxx;10 xxxxxxxxxx

Xxxxx xxxxxxxxxxxxxxx (inactivatum)⁴

Typus 1 (Xxxxxxx) 40 X xxxxxxxx xxxxxxxx⁵

Xxxxx 2 (MEF-1) 8 X xxxxxxxx xxxxxxxx⁵

Xxxxx 3 (Saukett) 32 X xxxxxxxx xxxxxxxx⁵

Xxxxxxxxxxxxxx Xxxxxxxxxx xxxxxxxxxx&xxxx;xxxxx x

(Xxxxxxxxxxxxxxxxxxx xxxxxxxx) 3 mikrogramy xxxxxxxxxx xxx xxxxxxxxx xxxxxxxxxxxx xxxxx x²&xxxx;50 xxxxxxxxxx

¹&xxxx;xxxxxxxxxxx na xxxxxxxxxxx xxxxxxx (0,17 xx Xx³⁺)

²&xxxx;xxxxxxxxxxx na xxxxxxxxxxx xxxxxxxx xxxxxxx sulfát (0,15 mg Xx³⁺)

³&xxxx;xxxxxxxx xxxxxxxxxxxxx DNA xxxxxxxxxxx x kvasinkových buňkách Saccharomyces xxxxxxxxxx

⁴&xxxx;xxxxxxxxx na Vero xxxxxxx

⁵&xxxx;xxxx ekvivalentní množství xxxxxxxx xxxxxxxxx xxxxxxx xxxxxxxxxxxxxx xxxxxxx.

⁶&xxxx;xxxx xxxxxxxxxxxx xxxxxxxx stanovená xxxxxxxxxxxx xxxxxxxxxxx

1x) xxxxxxxx xxxxx xxxxx xxxxxxx, dávivému xxxxx (xxxxxxxxxx xxxxx), xxxxxx (XXxX)

Xxxxx xxxxx (0,5 xx) xxxxxxxx xxxx léčivé xxxxx:

Xxxxxxxxxxx xxxxxxxxxx* ≥ 30 XX

Xxxxxx xxxxxxxxxx* ≥ 40 XX

Xxxxxxxxx anatoxinum* (XX) 25 mikrogramů

Pertussis xxxxxxxxxxxxxxx xxxxxxxxxxxx* (XXX) 25 mikrogramů

Pertactinum* (69xX) 8 mikrogramů

* xxxxxxxxxxx xx xxxxxxxx xxxxxxx xxxxxx: 0,5 miligramů

NEBO

1ba) Xxxxxxxx xxxxx proti xxxxxxx, xxxxxx x xxxxxxxx xxxxx (xxxxxxxxxx) xx xxxxxxxx xxxxxxx xxxxxxxx (Tdap)

Jedna dávka (0,5 xx) obsahuje:

Diphtheriae xxxxxxxxxx - Xxxxxxxxx 2 XX* (2 Xx)

Xxxxxx xxxxxxxxxx - Xxxxxxxxx 20 XX* (5 Lf)

Pertusové antigeny

Pertussis xxxxxxxxxx - 2,5 xxxxxxxxxx

Xxxxxxxxxxxxxx xxxxxxxxxxxx - 5 xxxxxxxxxx

Xxxxxxxxxxx - 3 xxxxxxxxxx

Xxxxxxxx, xxxx 2 et 3 - 5 xxxxxxxxxx

Xxxxxxxxxxx xx xxxxxxxxxxx xxxxxxx - 1,5 xx (0,33 xx xxxxxxx)

* Xxxx xxxxxx xxxxxxx xxxxxxxxx xxxxxxxxxxxxx (x = 0,95) aktivity xxxxxx xxxxx xxxxx xxxxxxxxx x Evropském xxxxxxxx.

XXXX

1xx) Xxxxxxxx látka xxxxx xxxxxxx, xxxxxx x xxxxxxxx xxxxx (xxxxxxxxxx xxxxxxxxxx) xx xxxxxxxx obsahem xxxxxxxx (Xxxx)

Xxxxx dávka (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx xxxxxxxxxx¹&xxxx;xx xxxx xxx 2 xxxxxxxxxxx jednotky (XX) (2,5 Xx)

Xxxxxx anatoxinum¹ ne xxxx než 20 xxxxxxxxxxxxx xxxxxxxx (XX) (5 Xx)

Xxxxxxxxxxx pertussis xxxxxxxx:

Xxxxxxxxx anatoxinum¹ 8 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxx filamentosum¹ 8 mikrogramů

Pertactinum¹ 2,5 xxxxxxxxxx

¹&xxxx;xxxxxxxxxxx na xxxxxxxxxxx xxxxxxxx xxxxxxx (Xx(XX)₃) 0,3 miligramů Xx^3+&xxxx;x xxxxxxxxxxx xxxxxxx (XxXX₄) 0,2 xxxxxxxxx Al³⁺

1c) xxxxxxxx xxxxx proti xxxxxxx vyvolaným Xxxxxxxxxxx xxxxxxxxxx xxx x:

Xx xxxxxxxxxxxx 1 dávka (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx xxxxxxxxxx xxxxx x xxxxxxxxxxxxxxx 10 xxxxxxxxxx

xxxxxxxxxxx x tetanickým xxxxxxxx xxxx xxxxxxxxxxx nosičem xxxxxxxxx 25 xxxxxxxxxx

1x) xxxxxxxx xxxxx proti xxxxxx:

Xxxxx xxxxx xxxxxxxx:

Xxxxxx xxxxxxxxxx - xxx. 40 xxxxxxxxxxxxx xxxxxxxx

1x) xxxxxxxx xxxxx xxxxx xxxxxx xxxxxxxxxx X x xxxxxx xxxxxxx:

Xxxxx xxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx B - 10 mikrogramů

1f) xxxxxxxx xxxxx xxxxx virové xxxxxxxxxx X v xxxxxxx formuli:

Jedna xxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx X - 20 xxxxxxxxxx

1x) xxxxxxxx xxxxx xxxxx spalničkám, příušnicím x zarděnkám:

1 xxxxx xxxxxxxxxxxxxxx xxxxxxx (0,5 xx) obsahuje:

Morbillorum virus xxxxxxxxxx¹&xxxx;(Xxxxxxx) xxx. 10^3,0&xxxx;xxxxxxxx xxxxx pro xxxxxxxx xxxxxxx₅₀³

Xxxxxxxxxxx virus xxxxxxxxxx¹&xxxx;(XXX 4385) xxx. 10^3,7 infekční xxxxx pro buněčnou xxxxxxx₅₀³

Xxxxxxxx xxxxx xxxxxxxxxx^2&xxxx;(Xxxxxx XX 27/3) min. 10^3,0&xxxx;xxxxxxxx dávka pro xxxxxxxx xxxxxxx₅₀³

¹&xxxx;xxxxxxxxx xx xxxxxxx xxxxxxxx xxxxxx

²&xxxx;xxxxxxxxx xx lidských diploidních xxxxxxx (XXX-5)

³&xxxx;50% infekční xxxxx xxxxxxx kultury

NEBO

1ga) xxxxxxxx látka xxxxx xxxxxxxxxx, příušnicím x xxxxxxxxx

Xx xxxxxxxxxx xxxxxxxx xxxxx dávka (0,5 xx):

Xxxxx morbillorum¹ vivum xxxxxxxxxx (xxxx Xxxxxx’ Xxxxxxxxx) xx xxxx xxx 1x10³&xxxx;XXXX₅₀*

Xxxxx parotitidis¹ vivum xxxxxxxxxx (xxxx Jeryl Lynn™, xxxxxxx X) xx xxxx xxx 12,5x10³ CCID₅₀*

Virus xxxxxxxx^2&xxxx;xxxxx xxxxxxxxxx (xxxx Xxxxxx RA 27/3) xx xxxx xxx 1x10³&xxxx;XXXX₅₀*

* 50 % xxxxxxxx xxxxx xxxxxxx xxxxxxx

¹&xxxx;xxxxxxxx xx xxxxxxx xxxxxxxx xxxxxx.

²&xxxx;xxxxxxxx na xxxxxxxx xxxxxxxxxxx plicních XX-38 fibroblastech.

1h) očkovací xxxxx xxxxx dětské xxxxxxxx xxxxx x xxxxxxxxxxxx xxxxx:

Xxxxx xxxxx (0,5 ml) xxxxxxxx:

Xxxxx xxxxxxxxxxxxx xxxxxxxxxxx typus 1 (Xxxxxxx) ….. 29 xxxxxxxxxxx D xxxxxxxx**

Xxxxx xxxxxxxxxxxxx inactivatum xxxxx 2 (MEF-1) ……... 7 antigenních X xxxxxxxx**

Xxxxx xxxxxxxxxxxxx xxxxxxxxxxx xxxxx 3 (Xxxxxxx) ……. 26 xxxxxxxxxxx X jednotek**

^* Kultivováno xx VERO xxxxxxx

^**&xxxx;Xxxx xxxxxxxx xxxxxxxx xxxx xxxxx xxxxxx xxxx xx, xxxxx byla xxxxx xxxxxxxxx xxxx 40-8-32 X xxxxxxxx xxxxxxxx pro virus xxxx 1, 2 x 3, xxx xxxxxx jinou xxxxxxx xxxxxxxxxxxxxx metodou.

1ch) konjugovaná xxxxxxxx xxxxx xxxxx xxxxxxxxxxxxx infekcím

Jedna dávka (0,5 ml) xxxxxxxx:

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

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

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

xxxxxxxxxxxx xxxxxxxx (pneumokoka) Streptococcus xxxxxxxxxx&xxxx;xxxxxxxx 5^1,2&xxxx;2,2 μx

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

xxxxxxxxxxxx bakterie (xxxxxxxxxx)&xxxx;Xxxxxxxxxxxxx xxxxxxxxxx&xxxx;xxxxxxxx 6B^1,2 4,4 μx

xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx)&xxxx;Xxxxxxxxxxxxx pneumoniae sérotypu 7X^1,2&xxxx;2,2 μg

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

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

polysacharid xxxxxxxx (xxxxxxxxxx)&xxxx;Xxxxxxxxxxxxx pneumoniae sérotypu 10X^1,2&xxxx;2,2 μx

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

xxxxxxxxxxxx bakterie (xxxxxxxxxx)&xxxx;Xxxxxxxxxxxxx xxxxxxxxxx&xxxx;xxxxxxxx 12F^1,2 2,2 μx

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

xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx)&xxxx;Xxxxxxxxxxxxx xxxxxxxxxx&xxxx;xxxxxxxx 15X^1,2&xxxx;2,2 μx

xxxxxxxxxxxx bakterie (xxxxxxxxxx)&xxxx;Xxxxxxxxxxxxx xxxxxxxxxx&xxxx;xxxxxxxx 18X^1,2&xxxx;2,2 μx

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

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

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

polysacharid xxxxxxxx (pneumokoka) Streptococcus xxxxxxxxxx&xxxx;xxxxxxxx 23X^1,2&xxxx;2,2 μg

polysacharid xxxxxxxx (xxxxxxxxxx)&xxxx;Xxxxxxxxxxxxx pneumoniae sérotypu 33X^1,2&xxxx;2,2 μx

^1&xxxx;Xxxxxxxxxx x xxxxxx xxxxxxxxx XXX₁₉₇&xxxx;(xxxxxxxxx 51 μx xx dávku)

² Adsorbován xx fosforečnan hlinitý (0,125 xx hliníku xx xxxxx)

XXXX

1xxx) xxxxxxxxxxx xxxxxxxx xxxxx xxxxx xxxxxxxxxxxxx xxxxxxxx

1 dávka (0,5 xx) obsahuje:

Polysacharid xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 3¹&xxxx;4 μx

Xxxxxxxxxxxx xxxxxxxx (pneumokoka) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 6X¹&xxxx;4 μx

Xxxxxxxxxxxx bakterie (xxxxxxxxxx) Streptococcus xxxxxxxxxx xxxxxxxx 7X¹&xxxx;4 μx

Xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Streptococcus xxxxxxxxxx xxxxxxxx 8¹ 4 μx

Xxxxxxxxxxxx bakterie (xxxxxxxxxx) Xxxxxxxxxxxxx pneumoniae xxxxxxxx 9X¹&xxxx;4 μg

Polysacharid xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx pneumoniae xxxxxxxx 10A¹ 4 μg

Polysacharid xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx sérotypu 11A¹ 4 μx

Xxxxxxxxxxxx bakterie (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 12X¹&xxxx;4 μx

Xxxxxxxxxxxx bakterie (xxxxxxxxxx) Streptococcus pneumoniae xxxxxxxx 15X¹&xxxx;4 μx

Xxxxxxxxxxxx xxxxxxxx (pneumokoka) Xxxxxxxxxxxxx xxxxxxxxxx z xxXXx15X (xx-X-xxxxxxxxxxx xxxxxxx 15X)¹&xxxx;4 μx

Xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx sérotypu 16X¹&xxxx;4 μg

Polysacharid xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx pneumoniae xxxxxxxx 17F¹ 4 μx

Xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 19X¹&xxxx;4 μx

Xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 20X¹&xxxx;4 μg

Polysacharid xxxxxxxx (xxxxxxxxxx) Streptococcus xxxxxxxxxx xxxxxxxx 22X¹&xxxx;4 μg

Polysacharid xxxxxxxx (xxxxxxxxxx) Streptococcus xxxxxxxxxx xxxxxxxx 23A¹ 4 μx

Xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx sérotypu 23X¹&xxxx;4 μg

Polysacharid bakterie (xxxxxxxxxx) Streptococcus xxxxxxxxxx xxxxxxxx 24X¹&xxxx;4 μx

Xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 31¹&xxxx;4 μx

Xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx pneumoniae xxxxxxxx 33X¹&xxxx;4 μx

Xxxxxxxxxxxx bakterie (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 35X¹&xxxx;4 μx

^1&xxxx;Xxxxxxxxxx x xxxxxxxxxxx xxxxxxx XXX₁₉₇. XXX₁₉₇&xxxx;xx xxxxxxxxx xxxxxx xxxxxxxxxxxx xxxxxx (xxxxxxxxxxxxx x bakterie Xxxxxxxxxxxxxxx diphtheriae X7) xxxxxxxxxxxxx exprimovaný v xxxxxxxx Pseudomonas xxxxxxxxxxx.

XXXX

1xxx) xxxxxxxx xxxxx xxxxx xxxxxxxxxxxxx infekcím xxxxxxxxx x xxxxxxxxxx schématu:

1chba) xxxxxxxxxxx xxxxxxxx xxxxx xxxxxxxx:

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

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

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

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

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

Streptococci xxxxxxxxxx xxxxxxxx 6X^1,2&xxxx;xxxxxxxxxxxxxxx 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 xxxxxxxxxx xxxxxxxx 19A^1,2 polysaccharidum 2,0 mikrogramů

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

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

Xxxxxxxxxxxx xxxxxxxxxx serotypi 23F^1,2 polysaccharidum 2,0 xxxxxxxxxx

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

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

² Adsorbován xx xxxxxxxx xxxxxxxxxxx xxxxxxx.

X

1xxxx) xxxxxxxxxxxxxxx xxxxxxxx xxxxx xxxxxxxx:

xx 25 mikrogramech xxxxxxxxxxxxx 23 xxxxxxxxxxxxxx xxxxxxxxxxxxxxxxx sérotypů: 1, 2, 3, 4, 5, 6B, 7F, 8, 9X, 9X, 10X, 11A, 12X, 14, 15X, 17F, 18X, 19X, 19X, 20, 22F, 23X, 33X.

XXXX

1xxx) xxxxxxxx látky xxxxx xxxxxxxxxxxxx infekcím xxxxxxxxx v sekvenčním xxxxxxxx:

1xxxx) xxxxxxxxxxx xxxxxxxx xxxxx xxxxxxxx:

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

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 3¹ 2,2 µx

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

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx sérotypus 5¹ 2,2 µx

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

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

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

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

Streptococci xxxxxxxxxx polysaccharidum sérotypus 14¹&xxxx;2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 18X¹&xxxx;2,2µ x

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

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

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 23X¹&xxxx;2,2 µx

¹&xxxx;Xxxxxxxxxx x nosným xxxxxxxxx XXX₁₉₇&xxxx;x xxxxxxxxxx xx xxxxxxxxxxx xxxxxxx (0,125 xx xxxxxxx).

X

1xxxx) xxxxxxxxxxxxxxx xxxxxxxx látka xxxxxxxx:

xx 25 xxxxxxxxxxxx xxxxxxxxxxxxx 23 xxxxxxxxxxxxxx xxxxxxxxxxxxxxxxx xxxxxxxx: 1, 2, 3, 4, 5, 6B, 7X, 8, 9X, 9X, 10X, 11A, 12X, 14, 15X, 17X, 18X, 19X, 19A, 20, 22F, 23F, 33X.

1x) xxxxxxxx látka xxxxx xxxxxxx, xxxxxxxx xxxxx (acelulární xxxxx), xxxxxx, dětské xxxxxxxx xxxxx (inaktivovaná forma):

Jedna xxxxx (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx xxxxxxxxxx¹&xxxx;- xx xxxx než 2 xxxxxxxxxxx xxxxxxxx (XX) (2,5 Xx)

Xxxxxx xxxxxxxxxx¹ -^&xxxx;xx méně xxx 20 xxxxxxxxxxxxx jednotek (XX) (5 Lf)

Bordetellae xxxxxxxxx xxxxxxxx:

Xxxxxxxxx anatoxinum¹ -^&xxxx;8 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxx xxxxxxxxxxxx¹&xxxx;- 8 xxxxxxxxxx

Xxxxxxxxx¹&xxxx;2,5 xxxxxxxxxx

Xxxxx poliomyelitidis xxxxxxxxxxx:

xxxxx 1 (xxxx Mahoney)² 40 X jednotek xxxxxxxx

xxxxx 2 (xxxx XXX-1)²&xxxx;8 X xxxxxxxx xxxxxxxx

xxxxx 3 (kmen Saukett)² 32 X xxxxxxxx xxxxxxxx

^1&xxxx;xxxxxxxxxxx xx xxxxxxxxxxx xxxxxxxx xxxxxxx (Xx(XX)₃) 0,3 xxxxxxxxx Al³⁺ a xxxxxxxxxxx xxxxxxx (AlPO₄) 0,2 xxxxxxxxx Al³⁺

² pomnoženo xx XXXX xxxxxxx

XXXX

1xx) xxxxxxxx xxxxx proti záškrtu, xxxxxxxx xxxxx (xxxxxxxxxx xxxxx), tetanu, xxxxxx xxxxxxxx xxxxx (xxxxxxxxxxxx xxxxx):

Xxxxx dávka (0,5 xx) obsahuje:

Diphtheriae anatoxinum xxxxxxxxx 2 XX¹&xxxx;(2 Xx)

Xxxxxx anatoxinum xxxxxxxxx 20 XX¹&xxxx;(5 Xx)

Xxxxxxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxxx 2,5 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxxxx xxxxxxxxxxxx 5 xxxxxxxxxx

Xxxxxxxxxxx 3 xxxxxxxxxx

Xxxxxxxx, xxxx 2 xx 3 5 xxxxxxxxxx

Xxxxx poliomyelitidis (inactivatum)²

typus 1 (Xxxxxxx) 29 X xxxxxxxx xxxxxxxx³

xxxxx 2 (XXX1) 7 X xxxxxxxx xxxxxxxx³

xxxxx 3 (Xxxxxxx) 26 X xxxxxxxx antigenu³

Adsorbováno xx fosforečnan xxxxxxx 1,5 xx (0,33 xx Xx³⁺)

^1&xxxx;Xxxx xxxxxx xxxxxxx intervalu spolehlivosti (x = 0,95) xxxxxxxx xxxxxx xxxxx xxxxx xxxxxxxxx x Xxxxxxxxx xxxxxxxx.

^2&xxxx;&xxxx;Xxxxxxxxxxx na Xxxx xxxxxxx.

^3&xxxx;&xxxx;Xxxx xxxxxxxx xxxxxxxx xxxx xxxxx xxxxxx jako xx, xxxxx byla xxxxx xxxxxxxxx jako 40-8-32 X jednotek xxxxxxxx xxx xxxxx typu 1, 2 a 3, při xxxxxx xxxxx xxxxxxx xxxxxxxxxxxxxx xxxxxxx.

* Xxxx xxxxxx xxxxxxx xxxxxxxxx spolehlivosti (x = 0,95) xxxxxxxx měřené xxxxx xxxxx popsaného x Xxxxxxxxx xxxxxxxx.

** Xxxxxxxxxxx xx Xxxx xxxxxxx.

1x) xxxxxxxx xxxxx xxxxx xxxxxxxxxxx (XXX xxxxxxx)

1x)&xxxx;xxxxxxxx xxxxx proti xxxxxx xxxxxxxxxx X pro xxxxx zařazené xx xxxxxxxxxxxx programu:

Jedna xxxxx (0,5 xx) vakcíny xxxxxxxx:

Xxxxxxxxx tegiminis hepatitidis X^1,2,3&xxxx;- 20 xxxxxxxxxx

^1&xxxx;xxxxxxxxxx xx XX04X xxxxxxxxxx: - 3-X-xxxxxx-4′-xxxxxxxxxxxx-xxxxx X (XXX)²&xxxx;50 mikrogramů

² adsorbovaný xx xxxxxxxxxxx xxxxxxx (xxxxxx 0,5 xxxxxxxxx Xx³⁺)

³&xxxx;xxxxxxxx xx kultuře xxxxxxxxxxxx xxxxx&xxxx;(Xxxxxxxxxxxxx cerevisiae) rekombinantní XXX xxxxxxxxxxx.

2. Xxxxxxxxx xxxxxxx xxxxxxxxxx xxxxx xxx xxxxxxxx očkování

2a) xxxxxxxx xxxxx xxxxx xxxxxx xxxxxxxxxx X ve xxxxxxx xxx xxxxxxx:

Xxxxx xxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx B - 20 xxxxxxxxxx

2x) xxxxxxxx xxxxx xxxxx xxxxxxxxx

2x) xxxxxxxx xxxxx xxxxx xxxxxx xxxxxxxxxx X xx formuli pro xxxxxxx:

Xxxxx xxxxx xxxxxxxx:

Xxxxxxxxx X xxxxx xxxxxxxxxxx

2x) xxxxxxxx látka proti xxxxxxxxxx, příušnicím x xxxxxxxxx:

1 xxxxx rekonstituované xxxxxxx (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx xxxxx xxxxxxxxxx¹&xxxx;(Xxxxxxx) xxx. 10^3,0 infekční dávka xxx xxxxxxxx xxxxxxx₅₀³

Xxxxxxxxxxx xxxxx xxxxxxxxxx¹&xxxx;(XXX 4385) xxx. 10^3,7&xxxx;xxxxxxxx xxxxx xxx xxxxxxxx kulturu₅₀³

Rubeolae xxxxx xxxxxxxxxx^2&xxxx;(Xxxxxx XX 27/3) xxx. 10^3,0&xxxx;xxxxxxxx xxxxx xxx buněčnou xxxxxxx₅₀³

¹&xxxx;xxxxxxxxx xx buňkách xxxxxxxx xxxxxx

²&xxxx;xxxxxxxxx xx xxxxxxxx xxxxxxxxxxx xxxxxxx (XXX-5)

³&xxxx;50% xxxxxxxx xxxxx xxxxxxx kultury

NEBO

2da) xxxxxxxx xxxxx xxxxx spalničkám, xxxxxxxxxx x zarděnkám

Po xxxxxxxxxx obsahuje xxxxx xxxxx (0,5 ml):

Virus xxxxxxxxxxx¹&xxxx;xxxxx xxxxxxxxxx (kmen Xxxxxx’ Edmonston) xx xxxx xxx 1x10³&xxxx;XXXX₅₀*

Xxxxx xxxxxxxxxxx¹&xxxx;xxxxx xxxxxxxxxx (xxxx Xxxxx Xxxx™, xxxxxxx X) xx xxxx xxx 12,5x10³ CCID₅₀*

Virus xxxxxxxx²&xxxx;xxxxx xxxxxxxxxx (kmen Wistar XX 27/3) xx xxxx xxx 1x10³&xxxx;XXXX₅₀*

* 50% xxxxxxxx dávka xxxxxxx xxxxxxx

¹&xxxx;xxxxxxxx xx xxxxxxx xxxxxxxx embryí.

² vyrobeno xx xxxxxxxx xxxxxxxxxxx xxxxxxxx XX-38 xxxxxxxxxxxxx.

3. Xxxxxxxxx složení očkovacích xxxxx xxx mimořádná xxxxxxxx

3x) xxxxxxxx xxxxx xxxxx virové xxxxxxxxxx X ve formuli xxx xxxxxxx:

Xxxxx hepatitis X xxxxxxxxxxx

3x) xxxxxxxx xxxxx xxxxx xxxxxx xxxxxxxxxx A xx xxxxxxx xxx děti:

Virus xxxxxxxxx X xxxxxxxxxxx

3x) xxxxxxxx xxxxx xxxxx xxxxxxxxxx, xxxxxxxxxx x xxxxxxxxx:

1 dávka rekonstituované xxxxxxx (0,5 ml) xxxxxxxx:

Xxxxxxxxxxx xxxxx xxxxxxxxxx¹&xxxx;(Xxxxxxx) xxx. 10^3,0 infekční xxxxx xxx xxxxxxxx kulturu₅₀³

Parotitidis xxxxx xxxxxxxxxx¹&xxxx;(XXX 4385) xxx. 10^3,7&xxxx;xxxxxxxx dávka xxx xxxxxxxx xxxxxxx₅₀³

Xxxxxxxx xxxxx xxxxxxxxxx^2&xxxx;(Xxxxxx RA 27/3) xxx. 10^3,0 infekční xxxxx xxx buněčnou xxxxxxx₅₀³

¹&xxxx;xxxxxxxxx xx xxxxxxx xxxxxxxx embryí

² pomnoženo xx xxxxxxxx xxxxxxxxxxx xxxxxxx (XXX-5)

³&xxxx;50% infekční xxxxx xxxxxxx kultury

NEBO

3ca) očkovací xxxxx xxxxx xxxxxxxxxx, xxxxxxxxxx x xxxxxxxxx

Xx xxxxxxxxxx xxxxxxxx xxxxx xxxxx (0,5 xx):

Xxxxx xxxxxxxxxxx¹&xxxx;xxxxx xxxxxxxxxx (kmen Xxxxxx’ Xxxxxxxxx) xx xxxx než 1x10³ CCID₅₀*

Virus xxxxxxxxxxx¹&xxxx;xxxxx xxxxxxxxxx (kmen Xxxxx Lynn™, xxxxxxx X) xx xxxx xxx 12,5x10³ CCID₅₀*

Virus rubeolae² vivum xxxxxxxxxx (xxxx Xxxxxx XX 27/3) xx xxxx xxx 1x110³&xxxx;XXXX₅₀*

* 50% infekční xxxxx xxxxxxx kultury

¹ vyrobeno xx xxxxxxx xxxxxxxx embryí.

² vyrobeno xx xxxxxxxx diploidních xxxxxxxx WI-38 fibroblastech.
 

Ministr:

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

Xxxxxxxxx

Xxxxxx xxxxxxx x. 528/2025 Xx. nabyl xxxxxxxxx xxxx 12.12.2025.

Xx xxx xxxxxxxx právní xxxxxxx xxxxx měněn xx xxxxxxxxx.

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