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 xxxxxxxxxxxxx

xx xxx 10. xxxxxxxx 2025

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

Xxxxxxxxxxxx xxxxxxxxxxxxx xxxxx §80 odst. 1 xxxx. x) xxxxxx x. 258/2000 Sb., x ochraně xxxxxxxxx xxxxxx x x xxxxx některých xxxxxxxxxxxxx xxxxxx, xx znění xxxxxxxxxx předpisů, stanoví xx základě doporučení Xxxxxxx xxxxxxxxxx xxxxxx xxxxxxxxx xxxxxxx xxxxxxxxxx xxxxx xxx xxxxxxxxxx, xxxxxxxx x xxxxxxxxx xxxxxxxx xxx xxx 2026:

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

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

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

Xxxxxxxxxxx anatoxinum¹ ne xxxx xxx 30 mezinárodních xxxxxxxx (IU)

Tetani anatoxinum¹ ne xxxx xxx 40 xxxxxxxxxxxxx xxxxxxxx (XX)

Xxxxxxxx&xxxx;Xxxxxxxxxx xxxxxxxxx:

Xxxxxxxxx anatoxinum (XX)¹&xxxx;25 xxxxxxxxxx

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

Xxxxxxxxxxx (PRN)¹ 8 xxxxxxxxxx

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

Xxxxx xxxxxxxxxxxxxxx xxxxxxxxxxx (XXX)

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

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

typus 3 (xxxx Saukett)⁴ 32 X jednotek antigenu

Haemophilus xxxxxxxxxx typus b xxxxxxxxxxxxxxx

(Xxxxxxxxxxxxxxxxxxx xxxxxxxx) 10 xxxxxxxxxx

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

¹&xxxx;xxxxxxxxxxx xx xxxxxxxx xxxxxxx, xxxxxxxxxxx (Xx(XX)₃) 0,5 xxxxxxxxx Xx³⁺

²&xxxx;xxxxxxxx xxxxxxxxxxxxx XXX xxxxxxxxxxx xx xxxxxxx xxxxxxxxxxxx buněk (Xxxxxxxxxxxxx xxxxxxxxxx)

³&xxxx;xxxxxxxxxxx na xxxxxxxxxxx xxxxxxx (XxXX₄) 0,32 xxxxxxxxx Al³⁺

⁴ pomnoženo xx VERO xxxxxxx

XXXX

1xx)&xxxx;xxxxxxxxxxx xxxxxxxx xxxxx proti xxxxxxx, dávivému xxxxx (xxxxxxxxxx xxxxx), tetanu, xxxxxx přenosné xxxxx (xxxxxxxxxxxx xxxxx), virové xxxxxxxxxx X, nákazám xxxxxxxxx Xxxxxxxxxxx xxxxxxxxxx xxx x (XXxXXxxXXXXXX)

Xxxxx xxxxx¹&xxxx;(0,5 xx) xxxxxxxx:

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

Xxxxxx xxxxxxxxxx xx méně xxx 40 mezinárodních xxxxxxxx (XX)^3,4&xxxx;(10 Lf)

Antigeny Xxxxxxxxxx xxxxxxxxx

Xxxxxxxxx xxxxxxxxxx 25 xxxxxxxxxx

Xxxxxxxxx haemagglutininum xxxxxxxxxxxx 25 xxxxxxxxxx

Xxxxx Xxxxxxxxxxxxxxx (xxxxxxxxxxxx)⁵

xxxxx 1 (Xxxxxxx) 29 D xxxxxxxx xxxxxxxx⁶

xxxxx 2 (XXX-1) 7 X xxxxxxxx xxxxxxxx⁶

xxxxx 3 (Xxxxxxx) 26 X xxxxxxxx xxxxxxxx⁶

Xxxxxxxxx xxxxxxxxxxx X xxxxxxxxx⁷&xxxx;10 mikrogramů

Haemophili xxxxxxxxxx typi B xxxxxxxxxxxxxxx (Xxxxxxxxxxxxxxxxxxx xxxxxxxx) 12 mikrogramů

coniugatum xxx xxxxxx xxxxxxxx 22-36 xxxxxxxxxx

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

²&xxxx;Xxxx spodní xxx xxxxxxxxxxxxx (x = 0,95) a xx xxxx xxx 30 IU jako xxxxxxx xxxxxxx

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

⁴&xxxx;Xxxx xxxxxxxxxxxx xxxxxxxx xxxxxxxxx hodnocením xxxxxxxxxxx

^5&xxxx;Xxxxxxxxxxx na Xxxx xxxxxxx

^6&xxxx;Xxxx xxxxxxxx antigenu xxxx úplně xxxxxx xxxx xx, xxxxx xxxx xxxxx vyjádřená xxxx 40-8-32 X xxxxxxxx xxxxxxxx xxx xxxxx xxxx 1, 2 x 3, xxx měření jinou xxxxxxx xxxxxxxxxxxxxx metodou.

⁷ vyrobeno xxxxxxxxxxxxx DNA technologií x xxxxxxxxxxxx buňkách Xxxxxxxxx xxxxxxxxxx

XXXX

1xx) Vakcína xxxxx xxxxxxx, xxxxxx, xxxxxxxx xxxxx (acelulární xxxxxxxxxx), xxxxxxxxxx B (xXXX), xxxxxx xxxxxxxx xxxxx (inaktivovaná) a xxxxxxxxxxx xxxxxxx proti Xxxxxxxxxxx typu x (xxxxxxxxxxx)

Xxxxx xxxxx (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx xxxxxxxxxx¹ xx xxxx než 20 XX⁶

Xxxxxx anatoxinumˡ xx xxxx než 40 XX⁶

Xxxxxxxx&xxxx;Xxxxxxxxxxx pertusis¹

Pertussis xxxxxxxxxx (XX) 20 xxxxxxxxxx

Xxxxxxxxxxxxxxx xxxxxxxxxxxx (FHA) 20 xxxxxxxxxx

Xxxxxxxxxxx (PRN) 3 mikrogramy

Fimbriae typi 2 xx 3 (XXX) 5 mikrogramů

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

Xxxxx xxxxxxxxxxxxxxx (xxxxxxxxxxx)⁴

Xxxxx 1 (Xxxxxxx) 40 X jednotek xxxxxxxx⁵

Xxxxx 2 (XXX-1) 8 X jednotek xxxxxxxx⁵

Xxxxx 3 (Xxxxxxx) 32 X xxxxxxxx xxxxxxxx⁵

Xxxxxxxxxxxxxx Xxxxxxxxxx xxxxxxxxxx&xxxx;xxxxx b

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

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

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

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

⁴&xxxx;xxxxxxxxx xx Xxxx xxxxxxx

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

⁶&xxxx;xxxx ekvivalentní xxxxxxxx xxxxxxxxx xxxxxxxxxxxx xxxxxxxxxxx

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

Xxxxx dávka (0,5 xx) obsahuje xxxx léčivé látky:

Diphtheriae xxxxxxxxxx* ≥ 30 XX

Xxxxxx xxxxxxxxxx* ≥ 40 IU

Pertussis anatoxinum* (XX) 25 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxxxxx* (FHA) 25 xxxxxxxxxx

Xxxxxxxxxxx* (69kD) 8 xxxxxxxxxx

* xxxxxxxxxxx xx hydroxid xxxxxxx xxxxxx: 0,5 xxxxxxxxx

XXXX

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

Xxxxx xxxxx (0,5 ml) obsahuje:

Diphtheriae xxxxxxxxxx - Xxxxxxxxx 2 IU* (2 Xx)

Xxxxxx xxxxxxxxxx - Xxxxxxxxx 20 XX* (5 Lf)

Pertusové xxxxxxxx

Xxxxxxxxx xxxxxxxxxx - 2,5 xxxxxxxxxx

Xxxxxxxxxxxxxx xxxxxxxxxxxx - 5 xxxxxxxxxx

Xxxxxxxxxxx - 3 xxxxxxxxxx

Xxxxxxxx, xxxx 2 et 3 - 5 xxxxxxxxxx

Xxxxxxxxxxx xx fosforečnan xxxxxxx - 1,5 mg (0,33 xx xxxxxxx)

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

XXXX

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

Xxxxx xxxxx (0,5 xx) xxxxxxxx:

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

Tetani xxxxxxxxxx¹&xxxx;xx xxxx než 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 xx xxxxxxxxxxx xxxxxxxx xxxxxxx (Xx(XX)₃) 0,3 miligramů Xx^3+&xxxx;x xxxxxxxxxxx xxxxxxx (XxXX₄) 0,2 xxxxxxxxx Xx³⁺

1x) xxxxxxxx xxxxx xxxxx xxxxxxx xxxxxxxxx Xxxxxxxxxxx xxxxxxxxxx xxx b:

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

Xxxxxxxxxxx xxxxxxxxxx xxxxx b xxxxxxxxxxxxxxx 10 xxxxxxxxxx

xxxxxxxxxxx x xxxxxxxxxx xxxxxxxx xxxx xxxxxxxxxxx nosičem xxxxxxxxx 25 xxxxxxxxxx

1x) xxxxxxxx xxxxx xxxxx xxxxxx:

Xxxxx dávka xxxxxxxx:

Xxxxxx xxxxxxxxxx - min. 40 mezinárodních jednotek

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

Xxxxx xxxxx obsahuje:

Antigenum tegiminis xxxxxxxxxxx B - 10 mikrogramů

1f) xxxxxxxx xxxxx proti virové xxxxxxxxxx B v xxxxxxx xxxxxxx:

Xxxxx dávka xxxxxxxx:

Xxxxxxxxx xxxxxxxxx hepatitidis X - 20 xxxxxxxxxx

1x) 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 virus attenuatum¹ (RIT 4385) xxx. 10^3,7&xxxx;xxxxxxxx xxxxx xxx xxxxxxxx xxxxxxx₅₀³

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

¹&xxxx;xxxxxxxxx xx xxxxxxx xxxxxxxx embryí

² pomnoženo xx xxxxxxxx xxxxxxxxxxx xxxxxxx (XXX-5)

³&xxxx;50% xxxxxxxx xxxxx tkáňové xxxxxxx

XXXX

1xx) xxxxxxxx xxxxx proti xxxxxxxxxx, příušnicím a xxxxxxxxx

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

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

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

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

* 50 % xxxxxxxx xxxxx buněčné xxxxxxx

¹&xxxx;xxxxxxxx na buňkách xxxxxxxx xxxxxx.

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

1h) očkovací xxxxx xxxxx xxxxxx xxxxxxxx xxxxx x xxxxxxxxxxxx formě:

Jedna dávka (0,5 xx) obsahuje:

Virus xxxxxxxxxxxxx xxxxxxxxxxx xxxxx 1 (Xxxxxxx) ….. 29 xxxxxxxxxxx X xxxxxxxx**

Xxxxx poliomyelitis xxxxxxxxxxx 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 jako xx, která byla xxxxx xxxxxxxxx jako 40-8-32 X xxxxxxxx xxxxxxxx xxx xxxxx xxxx 1, 2 x 3, xxx xxxxxx xxxxx xxxxxxx xxxxxxxxxxxxxx xxxxxxx.

1xx) xxxxxxxxxxx xxxxxxxx xxxxx proti xxxxxxxxxxxxx infekcím

Jedna xxxxx (0,5 xx) xxxxxxxx:

Xxxxxxxxxxxx xxxxxxxx (pneumokoka) Streptococcus pneumoniae sérotypu 1^1,2&xxxx;2,2 μx

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

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

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

polysacharid xxxxxxxx (xxxxxxxxxx)&xxxx;Xxxxxxxxxxxxx xxxxxxxxxx&xxxx;xxxxxxxx 7X^1,2&xxxx;2,2 μg

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

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

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

xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx)&xxxx;Xxxxxxxxxxxxx pneumoniae sérotypu 11A^1,2 2,2 μx

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

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

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

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

polysacharid xxxxxxxx (pneumokoka) Streptococcus 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 μg

polysacharid bakterie (xxxxxxxxxx)&xxxx;Xxxxxxxxxxxxx pneumoniae sérotypu 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 hlinitý (0,125 mg xxxxxxx xx xxxxx)

XXXX

1xxx) xxxxxxxxxxx xxxxxxxx xxxxx proti xxxxxxxxxxxxx xxxxxxxx

1 xxxxx (0,5 ml) xxxxxxxx:

Xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 3¹ 4 μx

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

Polysacharid xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 7X¹&xxxx;4 μg

Polysacharid xxxxxxxx (xxxxxxxxxx) Streptococcus xxxxxxxxxx xxxxxxxx 8¹ 4 μx

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

Polysacharid bakterie (xxxxxxxxxx) Xxxxxxxxxxxxx pneumoniae xxxxxxxx 10A¹ 4 μx

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

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

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

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

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

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

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

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

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

Xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx pneumoniae xxxxxxxx 24F¹ 4 μx

Xxxxxxxxxxxx xxxxxxxx (pneumokoka) Xxxxxxxxxxxxx xxxxxxxxxx sérotypu 31¹ 4 μx

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

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

¹ Konjugován x proteinovým xxxxxxx XXX₁₉₇. CRM₁₉₇ je xxxxxxxxx xxxxxx xxxxxxxxxxxx xxxxxx (xxxxxxxxxxxxx x xxxxxxxx Xxxxxxxxxxxxxxx diphtheriae X7) xxxxxxxxxxxxx xxxxxxxxxxx x xxxxxxxx Pseudomonas fluorescens.

NEBO

1chb) xxxxxxxx látky xxxxx xxxxxxxxxxxxx infekcím xxxxxxxxx x xxxxxxxxxx xxxxxxxx:

1xxxx) xxxxxxxxxxx xxxxxxxx xxxxx xxxxxxxx:

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

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

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

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

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

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

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

Streptococci xxxxxxxxxx xxxxxxxx 19A^1,2 polysaccharidum 2,0 xxxxxxxxxx

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

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

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

Streptococci pneumoniae xxxxxxxx 33F^1,2 polysaccharidum 2,0 xxxxxxxxxx

^1&xxxx;Xxxxxxxxxx s xxxxxxxxxxx xxxxxxx CRM₁₉₇. CRM₁₉₇ je xxxxxxxxx xxxxxx xxxxxxxxxxxx xxxxxx (pocházejícího x&xxxx;Xxxxxxxxxxxxxxx xxxxxxxxxxx&xxxx;X7) xxxxxxxxxxxxx xxxxxxxxxxxxx x&xxxx;Xxxxxxxxxxx xxxxxxxxxxx.

²&xxxx;Xxxxxxxxxx na xxxxxxxx xxxxxxxxxxx xxxxxxx.

X

1xxxx) xxxxxxxxxxxxxxx očkovací látka xxxxxxxx:

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

XXXX

1xxx) xxxxxxxx xxxxx xxxxx pneumokokovým xxxxxxxx xxxxxxxxx v xxxxxxxxxx xxxxxxxx:

1xxxx) xxxxxxxxxxx očkovací xxxxx xxxxxxxx:

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 1¹ 2,2 µx

Xxxxxxxxxxxx pneumoniae polysaccharidum xxxxxxxxx 3¹ 2,2 µg

Streptococci xxxxxxxxxx polysaccharidum xxxxxxxxx 4¹&xxxx;2,2 µg

Streptococci xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 5¹ 2,2 µx

Xxxxxxxxxxxx pneumoniae polysaccharidum xxxxxxxxx 6X¹&xxxx;2,2 µx

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

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

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

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

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

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

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

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 23F¹ 2,2 µx

¹&xxxx;Xxxxxxxxxx x xxxxxx xxxxxxxxx CRM₁₉₇ a xxxxxxxxxx xx xxxxxxxxxxx xxxxxxx (0,125 mg xxxxxxx).

X

1xxxx) xxxxxxxxxxxxxxx xxxxxxxx xxxxx xxxxxxxx:

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

1x) očkovací xxxxx xxxxx xxxxxxx, xxxxxxxx xxxxx (acelulární xxxxx), xxxxxx, xxxxxx přenosné xxxxx (xxxxxxxxxxxx xxxxx):

Xxxxx xxxxx (0,5 ml) xxxxxxxx:

Xxxxxxxxxxx anatoxinum¹ - ne xxxx než 2 xxxxxxxxxxx xxxxxxxx (XX) (2,5 Xx)

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

Xxxxxxxxxxx xxxxxxxxx antigena:

Pertussis xxxxxxxxxx¹ -^&xxxx;8 xxxxxxxxxx

Xxxxxxxxx haemagglutinum xxxxxxxxxxxx¹&xxxx;- 8 mikrogramů

Pertaktin¹ 2,5 xxxxxxxxxx

Xxxxx xxxxxxxxxxxxxxx xxxxxxxxxxx:

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

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

typus 3 (xxxx Saukett)² 32 X jednotek xxxxxxxx

^1&xxxx;xxxxxxxxxxx xx hydratovaný xxxxxxxx xxxxxxx (Xx(XX)₃) 0,3 xxxxxxxxx Xx^3+&xxxx;x fosforečnan xxxxxxx (AlPO₄) 0,2 xxxxxxxxx Xx³⁺

²&xxxx;xxxxxxxxx xx XXXX buňkách

NEBO

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

Xxxxx xxxxx (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx xxxxxxxxxx xxxxxxxxx 2 IU¹ (2 Xx)

Xxxxxx xxxxxxxxxx xxxxxxxxx 20 XX¹&xxxx;(5 Lf)

Pertusové xxxxxxxx:

Xxxxxxxxx xxxxxxxxxx 2,5 xxxxxxxxxx

Xxxxxxxxx haemagglutininum filamentosum 5 xxxxxxxxxx

Xxxxxxxxxxx 3 xxxxxxxxxx

Xxxxxxxx, xxxx 2 xx 3 5 xxxxxxxxxx

Xxxxx poliomyelitidis (xxxxxxxxxxx)²

xxxxx 1 (Xxxxxxx) 29 X xxxxxxxx xxxxxxxx³

xxxxx 2 (MEF1) 7 X xxxxxxxx antigenu³

typus 3 (Xxxxxxx) 26 X xxxxxxxx xxxxxxxx³

Xxxxxxxxxxx xx xxxxxxxxxxx xxxxxxx 1,5 mg (0,33 xx Al³⁺)

¹ Jako xxxxxx xxxxxxx intervalu xxxxxxxxxxxxx (x = 0,95) xxxxxxxx xxxxxx xxxxx xxxxx popsaného v Xxxxxxxxx xxxxxxxx.

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

^3&xxxx;&xxxx;Xxxx xxxxxxxx xxxxxxxx xxxx xxxxx xxxxxx jako ta, xxxxx xxxx xxxxx xxxxxxxxx xxxx 40-8-32 X jednotek xxxxxxxx xxx virus typu 1, 2 a 3, xxx měření xxxxx xxxxxxx imunochemickou xxxxxxx.

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

** Kultivováno xx Vero xxxxxxx.

1x) xxxxxxxx xxxxx xxxxx xxxxxxxxxxx (XXX xxxxxxx)

1x)&xxxx;xxxxxxxx xxxxx xxxxx xxxxxx xxxxxxxxxx B pro xxxxx xxxxxxxx do xxxxxxxxxxxx xxxxxxxx:

Xxxxx dávka (0,5 xx) vakcíny xxxxxxxx:

Xxxxxxxxx xxxxxxxxx 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 xxxxxxxxxx

²&xxxx;xxxxxxxxxxx na xxxxxxxxxxx xxxxxxx (xxxxxx 0,5 xxxxxxxxx Xx³⁺)

³&xxxx;xxxxxxxx xx xxxxxxx xxxxxxxxxxxx xxxxx&xxxx;(Xxxxxxxxxxxxx cerevisiae) rekombinantní DNA xxxxxxxxxxx.

2. Antigenní xxxxxxx xxxxxxxxxx látek xxx xxxxxxxx xxxxxxxx

2x) xxxxxxxx xxxxx xxxxx virové xxxxxxxxxx X xx xxxxxxx pro xxxxxxx:

Xxxxx xxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx B - 20 mikrogramů

2b) očkovací xxxxx xxxxx xxxxxxxxx

2x) xxxxxxxx xxxxx xxxxx xxxxxx xxxxxxxxxx A xx formuli xxx xxxxxxx:

Xxxxx dávka obsahuje:

Hepatitis X virus xxxxxxxxxxx

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

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

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

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

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

¹&xxxx;xxxxxxxxx na buňkách xxxxxxxx xxxxxx

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

³&xxxx;50% xxxxxxxx xxxxx xxxxxxx xxxxxxx

XXXX

2xx) očkovací xxxxx proti xxxxxxxxxx, xxxxxxxxxx x xxxxxxxxx

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

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

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

Xxxxx xxxxxxxx²&xxxx;xxxxx xxxxxxxxxx (kmen Xxxxxx XX 27/3) ne xxxx xxx 1x10³ CCID₅₀*

* 50% xxxxxxxx xxxxx xxxxxxx xxxxxxx

¹&xxxx;xxxxxxxx xx xxxxxxx xxxxxxxx xxxxxx.

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

3. Xxxxxxxxx xxxxxxx xxxxxxxxxx xxxxx pro xxxxxxxxx xxxxxxxx

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

Xxxxx xxxxxxxxx X xxxxxxxxxxx

3x) očkovací xxxxx xxxxx virové xxxxxxxxxx X xx xxxxxxx xxx xxxx:

Xxxxx xxxxxxxxx X xxxxxxxxxxx

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

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

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

Xxxxxxxxxxx xxxxx attenuatum¹ (RIT 4385) xxx. 10^3,7&xxxx;xxxxxxxx xxxxx xxx xxxxxxxx xxxxxxx₅₀³

Xxxxxxxx xxxxx xxxxxxxxxx^2&xxxx;(Xxxxxx 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 xxxxx xxxxxxx xxxxxxx

XXXX

3xx) xxxxxxxx xxxxx xxxxx spalničkám, xxxxxxxxxx a zarděnkám

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

Xxxxx xxxxxxxxxxx¹&xxxx;xxxxx attenuatum (xxxx Xxxxxx’ Xxxxxxxxx) xx xxxx xxx 1x10³ CCID₅₀*

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

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

* 50% xxxxxxxx xxxxx xxxxxxx kultury

¹ vyrobeno na xxxxxxx xxxxxxxx xxxxxx.

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

Ministr:

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

Informace

Právní předpis č. 528/2025 Xx. nabyl xxxxxxxxx xxxx 12.12.2025.

Xx xxx xxxxxxxx právní xxxxxxx xxxxx měněn xx xxxxxxxxx.

Xxxxx xxxxxxxxxxxx xxxxxxxx xxxxx jiných xxxxxxxx xxxxxxxx x xxxxxxxx není aktualizováno, xxxxx xx xxxx xxxxxx xxxxxxxxx xxxxx xxxxx xxxxxxxxx xxxxxxxx xxxxxxxx.