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

XXXXXXX

Xxxxxxxxxxxx zdravotnictví

ze dne 10. prosince 2025

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

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

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

1x) xxxxxxxxxxx&xxxx;xxxxxxxx xxxxx xxxxx záškrtu, dávivému xxxxx (xxxxxxxxxx xxxxx), xxxxxx, dětské xxxxxxxx xxxxx (xxxxxxxxxxxx forma), xxxxxx xxxxxxxxxx X, xxxxxxx xxxxxxxxx Xxxxxxxxxxx xxxxxxxxxx xxx x (XXxXXxxXXXXXX)

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

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

Tetani xxxxxxxxxx¹&xxxx;xx xxxx xxx 40 xxxxxxxxxxxxx xxxxxxxx (XX)

Xxxxxxxx&xxxx;Xxxxxxxxxx xxxxxxxxx:

Xxxxxxxxx xxxxxxxxxx (XX)¹&xxxx;25 xxxxxxxxxx

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

Pertactinum (PRN)¹ 8 xxxxxxxxxx

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

Xxxxx xxxxxxxxxxxxxxx xxxxxxxxxxx (IPV)

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

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

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

Xxxxxxxxxxx xxxxxxxxxx typus b polysaccharidum

(Polyribosylribitoli xxxxxxxx) 10 xxxxxxxxxx

xxxx. xxx anatox. xxxxxxxx xxxx xxxxx protein xxxxxxxxx 25 xxxxxxxxxx

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

²&xxxx;xxxxxxxx xxxxxxxxxxxxx XXX xxxxxxxxxxx na xxxxxxx xxxxxxxxxxxx xxxxx (Xxxxxxxxxxxxx xxxxxxxxxx)

³&xxxx;xxxxxxxxxxx xx xxxxxxxxxxx hlinitý (XxXX₄) 0,32 xxxxxxxxx Al³⁺

⁴ pomnoženo xx VERO xxxxxxx

XXXX

1xx)&xxxx;xxxxxxxxxxx xxxxxxxx látka xxxxx xxxxxxx, dávivému kašli (xxxxxxxxxx forma), xxxxxx, xxxxxx přenosné obrně (xxxxxxxxxxxx xxxxx), virové xxxxxxxxxx X, xxxxxxx xxxxxxxxx Xxxxxxxxxxx xxxxxxxxxx xxx x (XXxXXxxXXXXXX)

Xxxxx xxxxx¹&xxxx;(0,5 ml) obsahuje:

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

Xxxxxx xxxxxxxxxx ne méně xxx 40 mezinárodních xxxxxxxx (IU)^3,4 (10 Xx)

Xxxxxxxx Xxxxxxxxxx xxxxxxxxx

Xxxxxxxxx xxxxxxxxxx 25 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxxxx xxxxxxxxxxxx 25 xxxxxxxxxx

Xxxxx Xxxxxxxxxxxxxxx (xxxxxxxxxxxx)⁵

xxxxx 1 (Xxxxxxx) 29 D xxxxxxxx antigenu⁶

typus 2 (XXX-1) 7 X xxxxxxxx xxxxxxxx⁶

xxxxx 3 (Xxxxxxx) 26 D xxxxxxxx xxxxxxxx⁶

Xxxxxxxxx xxxxxxxxxxx X antigenum⁷ 10 xxxxxxxxxx

Xxxxxxxxxx xxxxxxxxxx xxxx X xxxxxxxxxxxxxxx (Xxxxxxxxxxxxxxxxxxx xxxxxxxx) 12 mikrogramů

coniugatum cum xxxxxx xxxxxxxx 22-36 xxxxxxxxxx

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

² Jako xxxxxx xxx xxxxxxxxxxxxx (p = 0,95) a xx xxxx než 30 XX xxxx xxxxxxx hodnota

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

⁴&xxxx;Xxxx xxxxxxxxxxxx xxxxxxxx stanovená xxxxxxxxxx xxxxxxxxxxx

^5&xxxx;Xxxxxxxxxxx na Vero xxxxxxx

^6&xxxx;Xxxx xxxxxxxx xxxxxxxx xxxx úplně stejná xxxx ta, xxxxx xxxx xxxxx vyjádřená xxxx 40-8-32 D xxxxxxxx xxxxxxxx pro xxxxx xxxx 1, 2 a 3, xxx měření jinou xxxxxxx xxxxxxxxxxxxxx metodou.

⁷ vyrobeno xxxxxxxxxxxxx DNA xxxxxxxxxxx x xxxxxxxxxxxx xxxxxxx Xxxxxxxxx xxxxxxxxxx

XXXX

1xx) Vakcína xxxxx záškrtu, xxxxxx, xxxxxxxx xxxxx (acelulární xxxxxxxxxx), xxxxxxxxxx X (xXXX), dětské xxxxxxxx xxxxx (xxxxxxxxxxxx) x xxxxxxxxxxx xxxxxxx xxxxx Xxxxxxxxxxx xxxx b (xxxxxxxxxxx)

Xxxxx xxxxx (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx xxxxxxxxxx¹ xx xxxx xxx 20 XX⁶

Xxxxxx xxxxxxxxxxˡ xx xxxx xxx 40 XX⁶

Xxxxxxxx&xxxx;Xxxxxxxxxxx pertusis¹

Pertussis xxxxxxxxxx (PT) 20 xxxxxxxxxx

Xxxxxxxxxxxxxxx xxxxxxxxxxxx (FHA) 20 xxxxxxxxxx

Xxxxxxxxxxx (XXX) 3 mikrogramy

Fimbriae typi 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 xxxxxxxx⁵

Xxxxx 2 (XXX-1) 8 X jednotek xxxxxxxx⁵

Xxxxx 3 (Xxxxxxx) 32 X xxxxxxxx antigenu⁵

Polysaccharidi Xxxxxxxxxx influenzae typus b

(Polyribosylribitoli xxxxxxxx) 3 xxxxxxxxxx xxxxxxxxxx xxx xxxxxxxxx xxxxxxxxxxxx typus x²&xxxx;50 xxxxxxxxxx

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

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

³&xxxx;xxxxxxxx xxxxxxxxxxxxx DNA technologií x xxxxxxxxxxxx buňkách Saccharomyces xxxxxxxxxx

⁴&xxxx;xxxxxxxxx xx Vero xxxxxxx

⁵&xxxx;xxxx ekvivalentní množství xxxxxxxx stanovené vhodnou xxxxxxxxxxxxxx xxxxxxx.

⁶&xxxx;xxxx ekvivalentní xxxxxxxx xxxxxxxxx vyhodnocením xxxxxxxxxxx

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

Xxxxx xxxxx (0,5 xx) obsahuje xxxx xxxxxx xxxxx:

Xxxxxxxxxxx xxxxxxxxxx* ≥ 30 XX

Xxxxxx anatoxinum* ≥ 40 XX

Xxxxxxxxx anatoxinum* (XX) 25 mikrogramů

Pertussis xxxxxxxxxxxxxxx xxxxxxxxxxxx* (FHA) 25 xxxxxxxxxx

Xxxxxxxxxxx* (69xX) 8 xxxxxxxxxx

* xxxxxxxxxxx xx xxxxxxxx hlinitý xxxxxx: 0,5 xxxxxxxxx

XXXX

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

Xxxxx dávka (0,5 xx) obsahuje:

Diphtheriae xxxxxxxxxx - Xxxxxxxxx 2 IU* (2 Xx)

Xxxxxx anatoxinum - Xxxxxxxxx 20 XX* (5 Lf)

Pertusové xxxxxxxx

Xxxxxxxxx xxxxxxxxxx - 2,5 xxxxxxxxxx

Xxxxxxxxxxxxxx filamentosum - 5 xxxxxxxxxx

Xxxxxxxxxxx - 3 xxxxxxxxxx

Xxxxxxxx, xxxx 2 xx 3 - 5 mikrogramů

Adsorbováno xx xxxxxxxxxxx hlinitý - 1,5 xx (0,33 xx hliníku)

* Xxxx xxxxxx hranice xxxxxxxxx xxxxxxxxxxxxx (p = 0,95) aktivity xxxxxx xxxxx testu xxxxxxxxx v Xxxxxxxxx xxxxxxxx.

XXXX

1xx) Očkovací xxxxx xxxxx xxxxxxx, xxxxxx x xxxxxxxx xxxxx (xxxxxxxxxx xxxxxxxxxx) se xxxxxxxx xxxxxxx xxxxxxxx (Xxxx)

Xxxxx xxxxx (0,5 xx) xxxxxxxx:

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

Xxxxxx anatoxinum¹ ne xxxx než 20 xxxxxxxxxxxxx jednotek (IU) (5 Lf)

Bordetellae xxxxxxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxxx¹&xxxx;8 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxx xxxxxxxxxxxx¹&xxxx;8 mikrogramů

Pertactinum¹ 2,5 xxxxxxxxxx

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

1c) xxxxxxxx látka proti xxxxxxx xxxxxxxxx Xxxxxxxxxxx xxxxxxxxxx typ x:

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

Xxxxxxxxxxx xxxxxxxxxx xxxxx x xxxxxxxxxxxxxxx 10 mikrogramů

konjugovaný x xxxxxxxxxx xxxxxxxx xxxx bílkovinným nosičem xxxxxxxxx 25 xxxxxxxxxx

1x) xxxxxxxx xxxxx xxxxx xxxxxx:

Xxxxx xxxxx obsahuje:

Tetani xxxxxxxxxx - xxx. 40 mezinárodních xxxxxxxx

1x) xxxxxxxx látka proti xxxxxx hepatitidě X x dětské formuli:

Jedna xxxxx xxxxxxxx:

Xxxxxxxxx tegiminis xxxxxxxxxxx X - 10 mikrogramů

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

Xxxxx xxxxx xxxxxxxx:

Xxxxxxxxx tegiminis xxxxxxxxxxx X - 20 xxxxxxxxxx

1x) očkovací xxxxx xxxxx xxxxxxxxxx, xxxxxxxxxx x xxxxxxxxx:

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

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

Xxxxxxxxxxx xxxxx attenuatum¹ (RIT 4385) xxx. 10^3,7 infekční xxxxx pro xxxxxxxx xxxxxxx₅₀³

Xxxxxxxx virus attenuatum² (Wistar XX 27/3) xxx. 10^3,0&xxxx;xxxxxxxx dávka pro xxxxxxxx xxxxxxx₅₀³

¹&xxxx;xxxxxxxxx xx xxxxxxx kuřecích xxxxxx

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

³&xxxx;50% xxxxxxxx xxxxx xxxxxxx kultury

NEBO

1ga) xxxxxxxx látka xxxxx xxxxxxxxxx, příušnicím a xxxxxxxxx

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

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

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

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

* 50 % xxxxxxxx xxxxx xxxxxxx xxxxxxx

¹&xxxx;xxxxxxxx xx xxxxxxx xxxxxxxx embryí.

² vyrobeno na xxxxxxxx xxxxxxxxxxx xxxxxxxx XX-38 xxxxxxxxxxxxx.

1x) očkovací xxxxx proti xxxxxx xxxxxxxx xxxxx x xxxxxxxxxxxx xxxxx:

Xxxxx xxxxx (0,5 xx) obsahuje:

Virus xxxxxxxxxxxxx inactivatum typus 1 (Xxxxxxx) ….. 29 antigenních X xxxxxxxx**

Xxxxx xxxxxxxxxxxxx inactivatum xxxxx 2 (XXX-1) ……... 7 xxxxxxxxxxx X jednotek**

Virus xxxxxxxxxxxxx xxxxxxxxxxx typus 3 (Xxxxxxx) ……. 26 xxxxxxxxxxx D xxxxxxxx**

^*&xxxx;Xxxxxxxxxxx xx XXXX xxxxxxx

^**&xxxx;Xxxx xxxxxxxx xxxxxxxx xxxx xxxxx stejná jako xx, která xxxx xxxxx vyjádřená xxxx 40-8-32 X xxxxxxxx xxxxxxxx xxx xxxxx xxxx 1, 2 x 3, xxx xxxxxx jinou xxxxxxx xxxxxxxxxxxxxx xxxxxxx.

1xx) konjugovaná xxxxxxxx xxxxx proti xxxxxxxxxxxxx infekcím

Jedna dávka (0,5 xx) obsahuje:

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

xxxxxxxxxxxx bakterie (xxxxxxxxxx)&xxxx;Xxxxxxxxxxxxx pneumoniae sérotypu 3^1,2 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 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 xxxxxxxxxx&xxxx;xxxxxxxx 7X^1,2&xxxx;2,2 μg

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

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

polysacharid xxxxxxxx (pneumokoka) Streptococcus xxxxxxxxxx&xxxx;xxxxxxxx 10X^1,2&xxxx;2,2 μx

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

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

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

polysacharid xxxxxxxx (pneumokoka) Streptococcus xxxxxxxxxx&xxxx;xxxxxxxx 19X^1,2&xxxx;2,2 μg

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

xxxxxxxxxxxx bakterie (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 nosným xxxxxxxxx XXX₁₉₇&xxxx;(xxxxxxxxx 51 μx xx xxxxx)

²&xxxx;Xxxxxxxxxx xx xxxxxxxxxxx xxxxxxx (0,125 xx hliníku xx dávku)

NEBO

1cha) konjugovaná xxxxxxxx xxxxx xxxxx xxxxxxxxxxxxx infekcím

1 dávka (0,5 ml) xxxxxxxx:

Xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 3¹ 4 μx

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

Polysacharid bakterie (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 7F¹ 4 μx

Xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx sérotypu 8¹&xxxx;4 μx

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

Polysacharid bakterie (xxxxxxxxxx) Xxxxxxxxxxxxx pneumoniae xxxxxxxx 10X¹&xxxx;4 μg

Polysacharid xxxxxxxx (pneumokoka) Streptococcus xxxxxxxxxx sérotypu 11X¹&xxxx;4 μx

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

Polysacharid xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 15A¹ 4 μx

Xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx x deOAc15B (xx-X-xxxxxxxxxxx xxxxxxx 15X)¹&xxxx;4 μx

Xxxxxxxxxxxx bakterie (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx sérotypu 16X¹&xxxx;4 μx

Xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 17X¹&xxxx;4 μg

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

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

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

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

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

Xxxxxxxxxxxx bakterie (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 24X¹&xxxx;4 μx

Xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 31¹ 4 μx

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

Xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx pneumoniae xxxxxxxx 35X¹&xxxx;4 μg

¹ Konjugován x xxxxxxxxxxx xxxxxxx XXX₁₉₇. CRM₁₉₇ je netoxický xxxxxx xxxxxxxxxxxx toxinu (xxxxxxxxxxxxx x xxxxxxxx Xxxxxxxxxxxxxxx xxxxxxxxxxx X7) xxxxxxxxxxxxx xxxxxxxxxxx v xxxxxxxx Pseudomonas fluorescens.

NEBO

1chb) xxxxxxxx látky proti xxxxxxxxxxxxx xxxxxxxx xxxxxxxxx x sekvenčním xxxxxxxx:

1xxxx) xxxxxxxxxxx xxxxxxxx látka xxxxxxxx:

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

Streptococci xxxxxxxxxx serotypi 3^1,2&xxxx;xxxxxxxxxxxxxxx 2,0 mikrogramů

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

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

Streptococci 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 mikrogramů

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

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

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

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

Xxxxxxxxxxxx xxxxxxxxxx serotypi 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&xxxx;Xxxxxxxxxx s xxxxxxxxxxx xxxxxxx XXX₁₉₇. XXX₁₉₇&xxxx;xx xxxxxxxxx xxxxxx xxxxxxxxxxxx xxxxxx (pocházejícího z Corynebacterium xxxxxxxxxxx&xxxx;X7) xxxxxxxxxxxxx xxxxxxxxxxxxx x&xxxx;Xxxxxxxxxxx xxxxxxxxxxx.

²&xxxx;Xxxxxxxxxx xx xxxxxxxx fosforečnan hlinitý.

A

1chbb) xxxxxxxxxxxxxxx xxxxxxxx látka xxxxxxxx:

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

XXXX

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

1xxxx) xxxxxxxxxxx xxxxxxxx xxxxx obsahuje:

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

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

Streptococci xxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 4¹&xxxx;2,2 µx

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

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

Streptococci xxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 6X¹&xxxx;4,4 µx

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

Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum xxxxxxxxx 9X¹&xxxx;2,2 µx

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

Streptococci xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 18C¹ 2,2µ x

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 19X¹&xxxx;2,2 µg

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

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

¹&xxxx;Xxxxxxxxxx s xxxxxx xxxxxxxxx CRM₁₉₇ a adsorbován xx fosforečnan xxxxxxx (0,125 xx xxxxxxx).

X

1xxxx) xxxxxxxxxxxxxxx xxxxxxxx xxxxx xxxxxxxx:

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

1x) xxxxxxxx xxxxx xxxxx xxxxxxx, dávivému xxxxx (xxxxxxxxxx xxxxx), xxxxxx, xxxxxx přenosné xxxxx (xxxxxxxxxxxx xxxxx):

Xxxxx xxxxx (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx anatoxinum¹ - ne xxxx xxx 2 xxxxxxxxxxx jednotky (XX) (2,5 Xx)

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

Xxxxxxxxxxx xxxxxxxxx antigena:

Pertussis xxxxxxxxxx¹ -^&xxxx;8 mikrogramů

Pertussis xxxxxxxxxxxxxx xxxxxxxxxxxx¹&xxxx;- 8 xxxxxxxxxx

Xxxxxxxxx¹&xxxx;2,5 xxxxxxxxxx

Xxxxx xxxxxxxxxxxxxxx xxxxxxxxxxx:

xxxxx 1 (kmen Mahoney)² 40 X xxxxxxxx xxxxxxxx

xxxxx 2 (xxxx MEF-1)² 8 X jednotek xxxxxxxx

xxxxx 3 (kmen Xxxxxxx)²&xxxx;32 X jednotek xxxxxxxx

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

²&xxxx;xxxxxxxxx xx XXXX xxxxxxx

XXXX

1xx) xxxxxxxx xxxxx xxxxx xxxxxxx, xxxxxxxx xxxxx (xxxxxxxxxx xxxxx), xxxxxx, xxxxxx xxxxxxxx xxxxx (xxxxxxxxxxxx xxxxx):

Xxxxx xxxxx (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx anatoxinum xxxxxxxxx 2 IU¹ (2 Xx)

Xxxxxx xxxxxxxxxx xxxxxxxxx 20 IU¹ (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 (xxxxxxxxxxx)²

xxxxx 1 (Mahoney) 29 X jednotek xxxxxxxx³

xxxxx 2 (MEF1) 7 X xxxxxxxx xxxxxxxx³

xxxxx 3 (Saukett) 26 X xxxxxxxx antigenu³

Adsorbováno xx fosforečnan hlinitý 1,5 xx (0,33 xx Al³⁺)

¹ Jako xxxxxx xxxxxxx intervalu xxxxxxxxxxxxx (x = 0,95) xxxxxxxx měřené podle xxxxx xxxxxxxxx x Xxxxxxxxx xxxxxxxx.

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

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

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

** Kultivováno xx Vero xxxxxxx.

1x) xxxxxxxx xxxxx xxxxx xxxxxxxxxxx (XXX xxxxxxx)

1x)&xxxx;xxxxxxxx xxxxx xxxxx virové xxxxxxxxxx X pro xxxxx xxxxxxxx do xxxxxxxxxxxx xxxxxxxx:

Xxxxx xxxxx (0,5 xx) xxxxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx X^1,2,3&xxxx;- 20 xxxxxxxxxx

^1&xxxx;xxxxxxxxxx xx AS04C obsahující: - 3-O-deacyl-4′-monofosforyl-lipid X (XXX)²&xxxx;50 mikrogramů

² adsorbovaný na xxxxxxxxxxx hlinitý (xxxxxx 0,5 xxxxxxxxx Xx³⁺)

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

2. Xxxxxxxxx xxxxxxx xxxxxxxxxx xxxxx xxx xxxxxxxx xxxxxxxx

2x) xxxxxxxx xxxxx xxxxx xxxxxx xxxxxxxxxx X ve xxxxxxx xxx dospělé:

Jedna xxxxx xxxxxxxx:

Xxxxxxxxx tegiminis xxxxxxxxxxx X - 20 mikrogramů

2b) xxxxxxxx xxxxx proti xxxxxxxxx

2x) xxxxxxxx xxxxx xxxxx xxxxxx hepatitidě A xx xxxxxxx xxx xxxxxxx:

Xxxxx dávka xxxxxxxx:

Xxxxxxxxx X xxxxx xxxxxxxxxxx

2x) xxxxxxxx xxxxx xxxxx xxxxxxxxxx, příušnicím x xxxxxxxxx:

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

Xxxxxxxxxxx virus attenuatum¹ (Schwarz) xxx. 10^3,0&xxxx;xxxxxxxx xxxxx xxx buněčnou xxxxxxx₅₀³

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

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

¹&xxxx;xxxxxxxxx xx buňkách xxxxxxxx embryí

² pomnoženo xx xxxxxxxx xxxxxxxxxxx xxxxxxx (XXX-5)

³&xxxx;50% xxxxxxxx dávka xxxxxxx xxxxxxx

XXXX

2xx) xxxxxxxx xxxxx proti xxxxxxxxxx, xxxxxxxxxx a xxxxxxxxx

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

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

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

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

* 50% xxxxxxxx dávka xxxxxxx xxxxxxx

¹&xxxx;xxxxxxxx xx xxxxxxx kuřecích xxxxxx.

²&xxxx;xxxxxxxx xx xxxxxxxx xxxxxxxxxxx xxxxxxxx WI-38 xxxxxxxxxxxxx.

3. Xxxxxxxxx xxxxxxx očkovacích xxxxx pro mimořádná xxxxxxxx

3x) očkovací xxxxx xxxxx virové xxxxxxxxxx X xx formuli xxx dospělé:

Virus hepatitis X xxxxxxxxxxx

3x) očkovací xxxxx xxxxx virové xxxxxxxxxx A xx xxxxxxx xxx děti:

Virus xxxxxxxxx A xxxxxxxxxxx

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

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

Xxxxxxxxxxx virus attenuatum¹ (Schwarz) xxx. 10^3,0&xxxx;xxxxxxxx xxxxx xxx xxxxxxxx kulturu₅₀³

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

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

¹&xxxx;xxxxxxxxx xx xxxxxxx xxxxxxxx xxxxxx

²&xxxx;xxxxxxxxx na xxxxxxxx diploidních xxxxxxx (XXX-5)

³&xxxx;50% infekční xxxxx xxxxxxx xxxxxxx

XXXX

3xx) xxxxxxxx xxxxx xxxxx xxxxxxxxxx, xxxxxxxxxx x xxxxxxxxx

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

Xxxxx xxxxxxxxxxx¹&xxxx;xxxxx attenuatum (xxxx Xxxxxx’ Xxxxxxxxx) xx xxxx než 1x10³&xxxx;XXXX₅₀*

Xxxxx xxxxxxxxxxx¹&xxxx;xxxxx xxxxxxxxxx (xxxx Xxxxx Lynn™, xxxxxxx X) xx xxxx xxx 12,5x10³&xxxx;XXXX₅₀*

Xxxxx xxxxxxxx²&xxxx;xxxxx xxxxxxxxxx (kmen Xxxxxx XX 27/3) ne xxxx xxx 1x110³ CCID₅₀*

* 50% xxxxxxxx dávka xxxxxxx xxxxxxx

¹&xxxx;xxxxxxxx xx xxxxxxx kuřecích xxxxxx.

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

Xxxxxxx:

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

Informace

Právní xxxxxxx č. 528/2025 Xx. xxxxx xxxxxxxxx xxxx 12.12.2025.

Xx xxx xxxxxxxx xxxxxx xxxxxxx xxxxx xxxxx xx doplňován.

Znění jednotlivých xxxxxxxx xxxxx xxxxxx xxxxxxxx xxxxxxxx x xxxxxxxx xxxx xxxxxxxxxxxxx, xxxxx xx xxxx xxxxxx xxxxxxxxx xxxxx xxxxx xxxxxxxxx právního xxxxxxxx.