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 xxx 10. xxxxxxxx 2025

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

Xxxxxxxxxxxx xxxxxxxxxxxxx podle §80 xxxx. 1 xxxx. x) zákona x. 258/2000 Xx., x xxxxxxx xxxxxxxxx xxxxxx a o xxxxx xxxxxxxxx souvisejících xxxxxx, ve znění xxxxxxxxxx xxxxxxxx, xxxxxxx xx xxxxxxx doporučení Xxxxxxx xxxxxxxxxx xxxxxx xxxxxxxxx složení xxxxxxxxxx xxxxx xxx pravidelná, xxxxxxxx x mimořádná xxxxxxxx pro xxx 2026:

1.&xxxx;Xxxxxxxxx xxxxxxx xxxxxxxxxx xxxxx pro pravidelná xxxxxxxx

1x) xxxxxxxxxxx&xxxx;xxxxxxxx xxxxx xxxxx záškrtu, xxxxxxxx xxxxx (acelulární xxxxx), xxxxxx, xxxxxx přenosné xxxxx (xxxxxxxxxxxx forma), xxxxxx hepatitidě X, xxxxxxx vyvolaným Xxxxxxxxxxx xxxxxxxxxx xxx x (XXxXXxxXXXXXX)

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

Xxxxxxxxxxx xxxxxxxxxx¹&xxxx;xx méně xxx 30 mezinárodních xxxxxxxx (XX)

Xxxxxx xxxxxxxxxx¹&xxxx;xx xxxx xxx 40 xxxxxxxxxxxxx xxxxxxxx (IU)

Antigeny Bordetelly xxxxxxxxx:

Xxxxxxxxx xxxxxxxxxx (XX)¹&xxxx;25 xxxxxxxxxx

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

Xxxxxxxxxxx (XXX)¹&xxxx;8 xxxxxxxxxx

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

Xxxxx xxxxxxxxxxxxxxx xxxxxxxxxxx (XXX)

xxxxx 1 (xxxx Mahoney)⁴ 40 X xxxxxxxx antigenu

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

xxxxx 3 (xxxx Saukett)⁴ 32 X xxxxxxxx xxxxxxxx

Xxxxxxxxxxx xxxxxxxxxx xxxxx&xxxx;x xxxxxxxxxxxxxxx

(Xxxxxxxxxxxxxxxxxxx xxxxxxxx) 10 xxxxxxxxxx

xxxx. xxx anatox. xxxxxxxx xxxx nosný xxxxxxx xxxxxxxxx 25 xxxxxxxxxx

¹&xxxx;xxxxxxxxxxx xx hydroxid xxxxxxx, xxxxxxxxxxx (Al(OH)₃) 0,5 xxxxxxxxx Xx³⁺

²&xxxx;xxxxxxxx xxxxxxxxxxxxx XXX technologií xx xxxxxxx xxxxxxxxxxxx xxxxx (Xxxxxxxxxxxxx xxxxxxxxxx)

³&xxxx;xxxxxxxxxxx na xxxxxxxxxxx hlinitý (XxXX₄) 0,32 miligramů Al³⁺

⁴ pomnoženo xx XXXX xxxxxxx

XXXX

1xx)&xxxx;xxxxxxxxxxx xxxxxxxx látka xxxxx xxxxxxx, xxxxxxxx kašli (xxxxxxxxxx xxxxx), xxxxxx, xxxxxx xxxxxxxx xxxxx (xxxxxxxxxxxx xxxxx), xxxxxx xxxxxxxxxx B, xxxxxxx xxxxxxxxx Xxxxxxxxxxx xxxxxxxxxx xxx b (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 mezinárodních xxxxxxxx (IU)^3,4 (10 Xx)

Xxxxxxxx Xxxxxxxxxx xxxxxxxxx

Xxxxxxxxx anatoxinum 25 mikrogramů

Pertussis xxxxxxxxxxxxxxxx xxxxxxxxxxxx 25 xxxxxxxxxx

Xxxxx Xxxxxxxxxxxxxxx (xxxxxxxxxxxx)⁵

xxxxx 1 (Xxxxxxx) 29 X xxxxxxxx xxxxxxxx⁶

xxxxx 2 (XXX-1) 7 D xxxxxxxx xxxxxxxx⁶

xxxxx 3 (Xxxxxxx) 26 X xxxxxxxx xxxxxxxx⁶

Xxxxxxxxx hepatitidis X xxxxxxxxx⁷&xxxx;10 mikrogramů

Haemophili xxxxxxxxxx xxxx B xxxxxxxxxxxxxxx (Xxxxxxxxxxxxxxxxxxx xxxxxxxx) 12 xxxxxxxxxx

xxxxxxxxxx xxx xxxxxx proteino 22-36 xxxxxxxxxx

^1&xxxx;Xxxxxxxxxxx xx xxxxxxxxxxx xxxxxxxx xxxxxxx (0,6 xx Al³⁺)

² Jako xxxxxx xxx xxxxxxxxxxxxx (x = 0,95) x xx xxxx než 30 IU xxxx xxxxxxx xxxxxxx

³&xxxx;Xxxx spodní xxx xxxxxxxxxxxxx (p = 0,95)

⁴&xxxx;Xxxx ekvivalentní xxxxxxxx xxxxxxxxx hodnocením xxxxxxxxxxx

^5&xxxx;Xxxxxxxxxxx na Xxxx xxxxxxx

^6&xxxx;Xxxx xxxxxxxx antigenu xxxx úplně xxxxxx xxxx xx, která xxxx dříve xxxxxxxxx xxxx 40-8-32 X xxxxxxxx xxxxxxxx xxx xxxxx xxxx 1, 2 a 3, xxx xxxxxx xxxxx xxxxxxx xxxxxxxxxxxxxx xxxxxxx.

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

XXXX

1xx) Vakcína xxxxx xxxxxxx, xxxxxx, xxxxxxxx xxxxx (xxxxxxxxxx xxxxxxxxxx), xxxxxxxxxx X (xXXX), xxxxxx přenosné xxxxx (xxxxxxxxxxxx) a xxxxxxxxxxx xxxxxxx xxxxx Xxxxxxxxxxx xxxx x (xxxxxxxxxxx)

Xxxxx xxxxx (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx xxxxxxxxxx¹ xx méně xxx 20 XX⁶

Xxxxxx xxxxxxxxxxˡ xx xxxx xxx 40 XX⁶

Xxxxxxxx&xxxx;Xxxxxxxxxxx xxxxxxxx¹

Xxxxxxxxx xxxxxxxxxx (XX) 20 xxxxxxxxxx

Xxxxxxxxxxxxxxx filamentosum (XXX) 20 xxxxxxxxxx

Xxxxxxxxxxx (XXX) 3 mikrogramy

Fimbriae xxxx 2 xx 3 (XXX) 5 xxxxxxxxxx

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

Xxxxx xxxxxxxxxxxxxxx (xxxxxxxxxxx)⁴

Xxxxx 1 (Xxxxxxx) 40 X xxxxxxxx antigenu⁵

Typus 2 (XXX-1) 8 X xxxxxxxx xxxxxxxx⁵

Xxxxx 3 (Saukett) 32 X xxxxxxxx xxxxxxxx⁵

Xxxxxxxxxxxxxx Xxxxxxxxxx influenzae typus x

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

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

²&xxxx;xxxxxxxxxxx xx xxxxxxxxxxx xxxxxxxx hlinitý xxxxxx (0,15 xx Xx³⁺)

³&xxxx;xxxxxxxx xxxxxxxxxxxxx XXX xxxxxxxxxxx x xxxxxxxxxxxx xxxxxxx&xxxx;Xxxxxxxxxxxxx xxxxxxxxxx

⁴&xxxx;xxxxxxxxx xx Xxxx xxxxxxx

⁵&xxxx;xxxx xxxxxxxxxxxx množství xxxxxxxx xxxxxxxxx xxxxxxx xxxxxxxxxxxxxx metodou.

⁶ nebo xxxxxxxxxxxx xxxxxxxx xxxxxxxxx vyhodnocením xxxxxxxxxxx

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

Xxxxx dávka (0,5 ml) xxxxxxxx xxxx xxxxxx xxxxx:

Xxxxxxxxxxx xxxxxxxxxx* ≥ 30 XX

Xxxxxx xxxxxxxxxx* ≥ 40 XX

Xxxxxxxxx xxxxxxxxxx* (XX) 25 mikrogramů

Pertussis xxxxxxxxxxxxxxx xxxxxxxxxxxx* (XXX) 25 xxxxxxxxxx

Xxxxxxxxxxx* (69xX) 8 xxxxxxxxxx

* xxxxxxxxxxx xx xxxxxxxx hlinitý xxxxxx: 0,5 xxxxxxxxx

XXXX

1xx) Xxxxxxxx xxxxx xxxxx xxxxxxx, tetanu x xxxxxxxx xxxxx (acelulární) xx xxxxxxxx xxxxxxx xxxxxxxx (Tdap)

Jedna dávka (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx xxxxxxxxxx - Minimálně 2 IU* (2 Xx)

Xxxxxx xxxxxxxxxx - Xxxxxxxxx 20 XX* (5 Xx)

Xxxxxxxxx antigeny

Pertussis xxxxxxxxxx - 2,5 xxxxxxxxxx

Xxxxxxxxxxxxxx xxxxxxxxxxxx - 5 mikrogramů

Pertactinum - 3 mikrogramy

Fimbriae, xxxx 2 et 3 - 5 xxxxxxxxxx

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

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

XXXX

1xx) Xxxxxxxx xxxxx xxxxx xxxxxxx, tetanu x dávivému kašli (xxxxxxxxxx komponenta) se xxxxxxxx obsahem xxxxxxxx (Xxxx)

Xxxxx xxxxx (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx xxxxxxxxxx¹&xxxx;xx xxxx xxx 2 xxxxxxxxxxx xxxxxxxx (XX) (2,5 Lf)

Tetani xxxxxxxxxx¹&xxxx;xx xxxx xxx 20 xxxxxxxxxxxxx jednotek (XX) (5 Xx)

Xxxxxxxxxxx xxxxxxxxx xxxxxxxx:

Xxxxxxxxx anatoxinum¹ 8 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxx filamentosum¹ 8 xxxxxxxxxx

Xxxxxxxxxxx¹&xxxx;2,5 xxxxxxxxxx

¹&xxxx;xxxxxxxxxxx na xxxxxxxxxxx xxxxxxxx xxxxxxx (Xx(XX)₃) 0,3 xxxxxxxxx Al³⁺ a xxxxxxxxxxx xxxxxxx (XxXX₄) 0,2 xxxxxxxxx Xx³⁺

1x) xxxxxxxx látka xxxxx xxxxxxx xxxxxxxxx Xxxxxxxxxxx xxxxxxxxxx typ b:

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

Xxxxxxxxxxx xxxxxxxxxx xxxxx x xxxxxxxxxxxxxxx 10 mikrogramů

konjugovaný x xxxxxxxxxx toxoidem xxxx bílkovinným xxxxxxx xxxxxxxxx 25 mikrogramů

1d) xxxxxxxx látka xxxxx xxxxxx:

Xxxxx xxxxx xxxxxxxx:

Xxxxxx xxxxxxxxxx - xxx. 40 mezinárodních xxxxxxxx

1x) xxxxxxxx látka proti xxxxxx xxxxxxxxxx X x dětské xxxxxxx:

Xxxxx xxxxx xxxxxxxx:

Xxxxxxxxx tegiminis xxxxxxxxxxx X - 10 xxxxxxxxxx

1x) xxxxxxxx xxxxx proti xxxxxx xxxxxxxxxx B x xxxxxxx xxxxxxx:

Xxxxx xxxxx xxxxxxxx:

Xxxxxxxxx tegiminis xxxxxxxxxxx X - 20 xxxxxxxxxx

1x) xxxxxxxx xxxxx xxxxx xxxxxxxxxx, xxxxxxxxxx x zarděnkám:

1 dávka xxxxxxxxxxxxxxx vakcíny (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx xxxxx xxxxxxxxxx¹&xxxx;(Xxxxxxx) min. 10^3,0&xxxx;xxxxxxxx xxxxx pro buněčnou xxxxxxx₅₀³

Xxxxxxxxxxx virus xxxxxxxxxx¹&xxxx;(XXX 4385) min. 10^3,7&xxxx;xxxxxxxx xxxxx xxx xxxxxxxx xxxxxxx₅₀³

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

¹&xxxx;xxxxxxxxx xx xxxxxxx xxxxxxxx embryí

² pomnoženo xx lidských xxxxxxxxxxx xxxxxxx (XXX-5)

³&xxxx;50% xxxxxxxx xxxxx tkáňové kultury

NEBO

1ga) xxxxxxxx látka proti xxxxxxxxxx, xxxxxxxxxx x xxxxxxxxx

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

Xxxxx xxxxxxxxxxx¹&xxxx;xxxxx xxxxxxxxxx (xxxx Enders’ Edmonston) xx méně xxx 1x10³&xxxx;XXXX₅₀*

Xxxxx parotitidis¹ vivum xxxxxxxxxx (xxxx Xxxxx Xxxx™, xxxxxxx X) xx xxxx než 12,5x10³ CCID₅₀*

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

* 50 % xxxxxxxx dávka xxxxxxx xxxxxxx

¹&xxxx;xxxxxxxx na xxxxxxx xxxxxxxx xxxxxx.

²&xxxx;xxxxxxxx xx xxxxxxxx diploidních xxxxxxxx XX-38 xxxxxxxxxxxxx.

1x) xxxxxxxx xxxxx xxxxx xxxxxx xxxxxxxx obrně x xxxxxxxxxxxx formě:

Jedna xxxxx (0,5 ml) xxxxxxxx:

Xxxxx xxxxxxxxxxxxx xxxxxxxxxxx typus 1 (Mahoney) ….. 29 xxxxxxxxxxx X xxxxxxxx**

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

Xxxxx xxxxxxxxxxxxx xxxxxxxxxxx xxxxx 3 (Xxxxxxx) ……. 26 xxxxxxxxxxx D xxxxxxxx**

^*&xxxx;Xxxxxxxxxxx xx XXXX xxxxxxx

^**&xxxx;Xxxx xxxxxxxx xxxxxxxx xxxx xxxxx xxxxxx xxxx xx, xxxxx xxxx xxxxx vyjádřená xxxx 40-8-32 D jednotek xxxxxxxx xxx xxxxx xxxx 1, 2 x 3, xxx xxxxxx xxxxx vhodnou xxxxxxxxxxxxxx xxxxxxx.

1xx) xxxxxxxxxxx xxxxxxxx xxxxx xxxxx xxxxxxxxxxxxx xxxxxxxx

Xxxxx xxxxx (0,5 ml) xxxxxxxx:

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

polysacharid bakterie (xxxxxxxxxx)&xxxx;Xxxxxxxxxxxxx pneumoniae sérotypu 3^1,2&xxxx;2,2 μx

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

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

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

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

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

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

xxxxxxxxxxxx xxxxxxxx (pneumokoka) Streptococcus xxxxxxxxxx&xxxx;xxxxxxxx 9X^1,2&xxxx;2,2 μx

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

polysacharid bakterie (xxxxxxxxxx)&xxxx;Xxxxxxxxxxxxx pneumoniae sérotypu 11X^1,2&xxxx;2,2 μx

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

polysacharid xxxxxxxx (xxxxxxxxxx)&xxxx;Xxxxxxxxxxxxx xxxxxxxxxx&xxxx;xxxxxxxx 14^1,2&xxxx;2,2 μg

polysacharid xxxxxxxx (xxxxxxxxxx)&xxxx;Xxxxxxxxxxxxx xxxxxxxxxx&xxxx;xxxxxxxx 15B^1,2 2,2 μx

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

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

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

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

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

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

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

² Adsorbován xx xxxxxxxxxxx xxxxxxx (0,125 xx hliníku xx dávku)

NEBO

1cha) xxxxxxxxxxx xxxxxxxx xxxxx xxxxx xxxxxxxxxxxxx xxxxxxxx

1 xxxxx (0,5 ml) obsahuje:

Polysacharid xxxxxxxx (pneumokoka) Xxxxxxxxxxxxx xxxxxxxxxx sérotypu 3¹ 4 μx

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

Polysacharid xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx pneumoniae xxxxxxxx 7F¹ 4 μg

Polysacharid xxxxxxxx (pneumokoka) Xxxxxxxxxxxxx xxxxxxxxxx sérotypu 8¹ 4 μx

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

Polysacharid bakterie (xxxxxxxxxx) Streptococcus xxxxxxxxxx xxxxxxxx 10X¹&xxxx;4 μx

Xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 11X¹&xxxx;4 μx

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

Xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Streptococcus xxxxxxxxxx xxxxxxxx 15A¹ 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 μx

Xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 17F¹ 4 μx

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

Xxxxxxxxxxxx xxxxxxxx (pneumokoka) Xxxxxxxxxxxxx xxxxxxxxxx sérotypu 20X¹&xxxx;4 μx

Xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 22X¹&xxxx;4 μx

Xxxxxxxxxxxx xxxxxxxx (pneumokoka) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 23X¹&xxxx;4 μx

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

Xxxxxxxxxxxx bakterie (xxxxxxxxxx) Streptococcus xxxxxxxxxx xxxxxxxx 24F¹ 4 μg

Polysacharid xxxxxxxx (xxxxxxxxxx) Streptococcus xxxxxxxxxx sérotypu 31¹ 4 μx

Xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx sérotypu 33X¹&xxxx;4 μg

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

^1&xxxx;Xxxxxxxxxx x xxxxxxxxxxx nosičem XXX₁₉₇. CRM₁₉₇ je xxxxxxxxx xxxxxx xxxxxxxxxxxx xxxxxx (xxxxxxxxxxxxx z bakterie Xxxxxxxxxxxxxxx xxxxxxxxxxx X7) xxxxxxxxxxxxx exprimovaný v xxxxxxxx Xxxxxxxxxxx xxxxxxxxxxx.

XXXX

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

1chba) xxxxxxxxxxx xxxxxxxx látka 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 serotypi 5^1,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx

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

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

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

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

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

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

Streptococci 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 mikrogramů

Streptococci xxxxxxxxxx serotypi 23X^1,2&xxxx;xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx

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

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

² Adsorbován xx xxxxxxxx xxxxxxxxxxx xxxxxxx.

X

1xxxx) xxxxxxxxxxxxxxx xxxxxxxx xxxxx xxxxxxxx:

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

XXXX

1xxx) xxxxxxxx látky xxxxx pneumokokovým xxxxxxxx xxxxxxxxx x xxxxxxxxxx xxxxxxxx:

1xxxx) konjugovaná xxxxxxxx xxxxx obsahuje:

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

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

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

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 5¹ 2,2 µx

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

Streptococci xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 6X¹&xxxx;4,4 µg

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

Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum xxxxxxxxx 9V¹ 2,2 µx

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

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

Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum xxxxxxxxx 19A¹ 2,2 µg

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

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

¹&xxxx;Xxxxxxxxxx x xxxxxx xxxxxxxxx CRM₁₉₇ a xxxxxxxxxx xx fosforečnan 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, 11X, 12X, 14, 15X, 17X, 18X, 19X, 19X, 20, 22X, 23X, 33X.

1x) xxxxxxxx xxxxx xxxxx xxxxxxx, dávivému xxxxx (acelulární xxxxx), xxxxxx, xxxxxx xxxxxxxx xxxxx (xxxxxxxxxxxx forma):

Jedna xxxxx (0,5 xx) xxxxxxxx:

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

Xxxxxx xxxxxxxxxx¹ -^&xxxx;xx xxxx xxx 20 xxxxxxxxxxxxx xxxxxxxx (XX) (5 Xx)

Xxxxxxxxxxx xxxxxxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxxx¹ -^&xxxx;8 xxxxxxxxxx

Xxxxxxxxx haemagglutinum xxxxxxxxxxxx¹&xxxx;- 8 xxxxxxxxxx

Xxxxxxxxx¹&xxxx;2,5 xxxxxxxxxx

Xxxxx poliomyelitidis xxxxxxxxxxx:

xxxxx 1 (xxxx Xxxxxxx)²&xxxx;40 X xxxxxxxx xxxxxxxx

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

typus 3 (kmen Saukett)² 32 X xxxxxxxx antigenu

¹ adsorbováno xx hydratovaný xxxxxxxx xxxxxxx (Al(OH)₃) 0,3 xxxxxxxxx Xx^3+&xxxx;x xxxxxxxxxxx xxxxxxx (XxXX₄) 0,2 xxxxxxxxx Al³⁺

² pomnoženo xx XXXX xxxxxxx

XXXX

1xx) očkovací xxxxx xxxxx záškrtu, xxxxxxxx xxxxx (xxxxxxxxxx xxxxx), xxxxxx, dětské xxxxxxxx obrně (xxxxxxxxxxxx xxxxx):

Xxxxx xxxxx (0,5 xx) obsahuje:

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

Xxxxxx xxxxxxxxxx minimálně 20 XX¹&xxxx;(5 Xx)

Xxxxxxxxx xxxxxxxx:

Xxxxxxxxx anatoxinum 2,5 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxxxx xxxxxxxxxxxx 5 mikrogramů

Pertactinum 3 xxxxxxxxxx

Xxxxxxxx, xxxx 2 xx 3 5 xxxxxxxxxx

Xxxxx xxxxxxxxxxxxxxx (xxxxxxxxxxx)²

xxxxx 1 (Xxxxxxx) 29 X jednotek xxxxxxxx³

xxxxx 2 (XXX1) 7 X jednotek antigenu³

typus 3 (Xxxxxxx) 26 X xxxxxxxx antigenu³

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

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

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

^3&xxxx;&xxxx;Xxxx množství xxxxxxxx xxxx xxxxx xxxxxx jako xx, xxxxx xxxx dříve xxxxxxxxx xxxx 40-8-32 X jednotek xxxxxxxx xxx xxxxx xxxx 1, 2 x 3, xxx xxxxxx xxxxx xxxxxxx xxxxxxxxxxxxxx xxxxxxx.

* Jako xxxxxx xxxxxxx intervalu xxxxxxxxxxxxx (x = 0,95) xxxxxxxx xxxxxx xxxxx xxxxx popsaného v Xxxxxxxxx xxxxxxxx.

** Kultivováno xx Vero xxxxxxx.

1x) xxxxxxxx xxxxx proti xxxxxxxxxxx (XXX xxxxxxx)

1x)&xxxx;xxxxxxxx xxxxx proti xxxxxx xxxxxxxxxx X xxx xxxxx xxxxxxxx xx xxxxxxxxxxxx xxxxxxxx:

Xxxxx xxxxx (0,5 xx) xxxxxxx xxxxxxxx:

Xxxxxxxxx tegiminis xxxxxxxxxxx X^1,2,3&xxxx;- 20 mikrogramů

¹ adjuvovaný xx AS04C obsahující: - 3-X-xxxxxx-4′-xxxxxxxxxxxx-xxxxx X (XXX)²&xxxx;50 mikrogramů

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

³&xxxx;xxxxxxxx xx kultuře xxxxxxxxxxxx xxxxx&xxxx;(Xxxxxxxxxxxxx xxxxxxxxxx)&xxxx;xxxxxxxxxxxxx XXX xxxxxxxxxxx.

2. Antigenní složení xxxxxxxxxx látek xxx xxxxxxxx očkování

2a) xxxxxxxx xxxxx xxxxx xxxxxx xxxxxxxxxx B xx xxxxxxx pro dospělé:

Jedna xxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx X - 20 xxxxxxxxxx

2x) očkovací xxxxx xxxxx vzteklině

2c) xxxxxxxx látka xxxxx xxxxxx hepatitidě X xx xxxxxxx xxx xxxxxxx:

Xxxxx dávka xxxxxxxx:

Xxxxxxxxx X virus inactivatum

2d) xxxxxxxx xxxxx proti xxxxxxxxxx, xxxxxxxxxx x xxxxxxxxx:

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

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

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

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

¹&xxxx;xxxxxxxxx xx xxxxxxx xxxxxxxx xxxxxx

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

³&xxxx;50% xxxxxxxx dávka xxxxxxx xxxxxxx

XXXX

2xx) xxxxxxxx xxxxx proti xxxxxxxxxx, xxxxxxxxxx a xxxxxxxxx

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

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

Virus xxxxxxxxxxx¹&xxxx;xxxxx xxxxxxxxxx (xxxx Xxxxx Xxxx™, hladina X) xx méně xxx 12,5x10³&xxxx;XXXX₅₀*

Xxxxx rubeolae² vivum xxxxxxxxxx (kmen Wistar XX 27/3) xx xxxx než 1x10³&xxxx;XXXX₅₀*

* 50% xxxxxxxx xxxxx xxxxxxx xxxxxxx

¹&xxxx;xxxxxxxx na xxxxxxx xxxxxxxx xxxxxx.

²&xxxx;xxxxxxxx xx lidských xxxxxxxxxxx xxxxxxxx XX-38 xxxxxxxxxxxxx.

3. Xxxxxxxxx xxxxxxx xxxxxxxxxx xxxxx pro xxxxxxxxx xxxxxxxx

3x) očkovací xxxxx xxxxx xxxxxx xxxxxxxxxx X xx xxxxxxx xxx dospělé:

Virus xxxxxxxxx X inactivatum

3b) xxxxxxxx xxxxx xxxxx xxxxxx xxxxxxxxxx X xx xxxxxxx pro xxxx:

Xxxxx xxxxxxxxx A inactivatum

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

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

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

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

Rubeolae xxxxx attenuatum² (Wistar XX 27/3) min. 10^3,0&xxxx;xxxxxxxx xxxxx xxx xxxxxxxx xxxxxxx₅₀³

¹&xxxx;xxxxxxxxx xx xxxxxxx xxxxxxxx xxxxxx

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

³&xxxx;50% xxxxxxxx dávka xxxxxxx kultury

NEBO

3ca) xxxxxxxx xxxxx xxxxx xxxxxxxxxx, xxxxxxxxxx x zarděnkám

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

Xxxxx xxxxxxxxxxx¹&xxxx;xxxxx attenuatum (kmen Xxxxxx’ Xxxxxxxxx) ne xxxx xxx 1x10³&xxxx;XXXX₅₀*

Xxxxx xxxxxxxxxxx¹&xxxx;xxxxx xxxxxxxxxx (kmen Xxxxx Lynn™, hladina X) ne méně xxx 12,5x10³&xxxx;XXXX₅₀*

Xxxxx xxxxxxxx²&xxxx;xxxxx xxxxxxxxxx (xxxx Xxxxxx XX 27/3) ne xxxx než 1x110³&xxxx;XXXX₅₀*

* 50% xxxxxxxx xxxxx xxxxxxx xxxxxxx

¹&xxxx;xxxxxxxx xx xxxxxxx kuřecích embryí.

² vyrobeno xx xxxxxxxx xxxxxxxxxxx xxxxxxxx XX-38 xxxxxxxxxxxxx.
&xxxx;

Xxxxxxx:

xxxx. XXXx. Xxxxx, CSc., XXX, XXXX, x. x.

Xxxxxxxxx

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

Xx xxx xxxxxxxx xxxxxx xxxxxxx nebyl měněn xx doplňován.

Znění xxxxxxxxxxxx xxxxxxxx xxxxx jiných xxxxxxxx xxxxxxxx v xxxxxxxx není aktualizováno, xxxxx xx jich xxxxxx xxxxxxxxx xxxxx xxxxx xxxxxxxxx xxxxxxxx xxxxxxxx.