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 xxx 10. prosince 2025

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

Xxxxxxxxxxxx xxxxxxxxxxxxx xxxxx §80 xxxx. 1 xxxx. x) xxxxxx x. 258/2000 Xx., x ochraně xxxxxxxxx xxxxxx a o xxxxx některých xxxxxxxxxxxxx xxxxxx, xx znění xxxxxxxxxx xxxxxxxx, xxxxxxx xx xxxxxxx xxxxxxxxxx Xxxxxxx xxxxxxxxxx xxxxxx xxxxxxxxx xxxxxxx očkovacích xxxxx xxx pravidelná, xxxxxxxx x xxxxxxxxx xxxxxxxx pro xxx 2026:

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

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

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

Xxxxxxxxxxx anatoxinum¹ ne méně xxx 30 mezinárodních xxxxxxxx (IU)

Tetani anatoxinum¹ ne xxxx xxx 40 xxxxxxxxxxxxx xxxxxxxx (IU)

Antigeny Bordetelly xxxxxxxxx:

Xxxxxxxxx xxxxxxxxxx (XX)¹&xxxx;25 xxxxxxxxxx

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

Pertactinum (PRN)¹ 8 xxxxxxxxxx

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

Xxxxx xxxxxxxxxxxxxxx inactivatum (XXX)

xxxxx 1 (kmen Mahoney)⁴ 40 X jednotek xxxxxxxx

xxxxx 2 (xxxx MEF-1)⁴ 8 X xxxxxxxx antigenu

typus 3 (xxxx Xxxxxxx)⁴&xxxx;32 X xxxxxxxx antigenu

Haemophilus xxxxxxxxxx xxxxx&xxxx;x polysaccharidum

(Polyribosylribitoli xxxxxxxx) 10 xxxxxxxxxx

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

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

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

³&xxxx;xxxxxxxxxxx xx xxxxxxxxxxx xxxxxxx (AlPO₄) 0,32 miligramů Xx³⁺

⁴&xxxx;xxxxxxxxx xx VERO buňkách

NEBO

1aa) kombinovaná xxxxxxxx xxxxx xxxxx xxxxxxx, dávivému xxxxx (xxxxxxxxxx xxxxx), tetanu, xxxxxx xxxxxxxx obrně (xxxxxxxxxxxx xxxxx), virové xxxxxxxxxx X, nákazám xxxxxxxxx Xxxxxxxxxxx xxxxxxxxxx xxx b (XXxXXxxXXXXXX)

Xxxxx xxxxx¹&xxxx;(0,5 ml) xxxxxxxx:

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

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

Xxxxxxxx Xxxxxxxxxx xxxxxxxxx

Xxxxxxxxx xxxxxxxxxx 25 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxxxx xxxxxxxxxxxx 25 xxxxxxxxxx

Xxxxx Xxxxxxxxxxxxxxx (xxxxxxxxxxxx)⁵

xxxxx 1 (Xxxxxxx) 29 X xxxxxxxx antigenu⁶

typus 2 (XXX-1) 7 X xxxxxxxx xxxxxxxx⁶

xxxxx 3 (Xxxxxxx) 26 D xxxxxxxx xxxxxxxx⁶

Xxxxxxxxx hepatitidis X xxxxxxxxx⁷&xxxx;10 xxxxxxxxxx

Xxxxxxxxxx xxxxxxxxxx typi B xxxxxxxxxxxxxxx (Polyribosylribitoli xxxxxxxx) 12 xxxxxxxxxx

xxxxxxxxxx xxx xxxxxx xxxxxxxx 22-36 xxxxxxxxxx

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

² Jako xxxxxx xxx xxxxxxxxxxxxx (x = 0,95) x xx méně xxx 30 XX xxxx xxxxxxx hodnota

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

⁴&xxxx;Xxxx xxxxxxxxxxxx xxxxxxxx stanovená xxxxxxxxxx xxxxxxxxxxx

^5&xxxx;Xxxxxxxxxxx xx Xxxx xxxxxxx

^6&xxxx;Xxxx množství xxxxxxxx xxxx xxxxx xxxxxx xxxx ta, xxxxx xxxx dříve vyjádřená xxxx 40-8-32 D xxxxxxxx xxxxxxxx pro xxxxx xxxx 1, 2 x 3, xxx xxxxxx xxxxx xxxxxxx imunochemickou xxxxxxx.

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

NEBO

1ab) Xxxxxxx xxxxx xxxxxxx, xxxxxx, xxxxxxxx kašli (xxxxxxxxxx xxxxxxxxxx), xxxxxxxxxx X (xXXX), xxxxxx přenosné xxxxx (xxxxxxxxxxxx) x xxxxxxxxxxx xxxxxxx xxxxx Xxxxxxxxxxx typu x (xxxxxxxxxxx)

Xxxxx xxxxx (0,5 xx) obsahuje:

Diphtheriae anatoxinum¹ xx méně než 20 XX⁶

Xxxxxx xxxxxxxxxxˡ xx xxxx xxx 40 IU⁶

Antigena Bordetellae xxxxxxxx¹

Xxxxxxxxx xxxxxxxxxx (XX) 20 xxxxxxxxxx

Xxxxxxxxxxxxxxx xxxxxxxxxxxx (XXX) 20 mikrogramů

Pertactinum (XXX) 3 xxxxxxxxxx

Xxxxxxxx xxxx 2 et 3 (XXX) 5 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx B^2,3 10 xxxxxxxxxx

Xxxxx poliomyelitidis (inactivatum)⁴

Typus 1 (Xxxxxxx) 40 X xxxxxxxx antigenu⁵

Typus 2 (MEF-1) 8 X xxxxxxxx xxxxxxxx⁵

Xxxxx 3 (Xxxxxxx) 32 X jednotek xxxxxxxx⁵

Xxxxxxxxxxxxxx Xxxxxxxxxx xxxxxxxxxx&xxxx;xxxxx x

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

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

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

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

⁴&xxxx;xxxxxxxxx xx Xxxx xxxxxxx

⁵&xxxx;xxxx xxxxxxxxxxxx xxxxxxxx xxxxxxxx xxxxxxxxx vhodnou xxxxxxxxxxxxxx xxxxxxx.

⁶&xxxx;xxxx xxxxxxxxxxxx xxxxxxxx xxxxxxxxx xxxxxxxxxxxx xxxxxxxxxxx

1x) xxxxxxxx látka xxxxx záškrtu, dávivému xxxxx (acelulární xxxxx), xxxxxx (XXxX)

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

Xxxxxxxxxxx xxxxxxxxxx* ≥ 30 XX

Xxxxxx xxxxxxxxxx* ≥ 40 XX

Xxxxxxxxx anatoxinum* (XX) 25 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxxxxx* (XXX) 25 mikrogramů

Pertactinum* (69xX) 8 mikrogramů

* xxxxxxxxxxx xx hydroxid xxxxxxx xxxxxx: 0,5 miligramů

NEBO

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

Xxxxx xxxxx (0,5 xx) obsahuje:

Diphtheriae xxxxxxxxxx - Xxxxxxxxx 2 IU* (2 Xx)

Xxxxxx xxxxxxxxxx - Xxxxxxxxx 20 IU* (5 Lf)

Pertusové xxxxxxxx

Xxxxxxxxx xxxxxxxxxx - 2,5 xxxxxxxxxx

Xxxxxxxxxxxxxx filamentosum - 5 xxxxxxxxxx

Xxxxxxxxxxx - 3 xxxxxxxxxx

Xxxxxxxx, xxxx 2 xx 3 - 5 xxxxxxxxxx

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

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

XXXX

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

Xxxxx dávka (0,5 xx) obsahuje:

Diphtheriae xxxxxxxxxx¹&xxxx;xx xxxx xxx 2 xxxxxxxxxxx jednotky (IU) (2,5 Lf)

Tetani anatoxinum¹ ne xxxx xxx 20 xxxxxxxxxxxxx jednotek (XX) (5 Xx)

Xxxxxxxxxxx xxxxxxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxxx¹&xxxx;8 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxx xxxxxxxxxxxx¹&xxxx;8 xxxxxxxxxx

Xxxxxxxxxxx¹&xxxx;2,5 xxxxxxxxxx

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

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

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

Xxxxxxxxxxx xxxxxxxxxx typus b xxxxxxxxxxxxxxx 10 mikrogramů

konjugovaný x xxxxxxxxxx xxxxxxxx xxxx bílkovinným xxxxxxx xxxxxxxxx 25 xxxxxxxxxx

1x) xxxxxxxx xxxxx xxxxx xxxxxx:

Xxxxx xxxxx obsahuje:

Tetani xxxxxxxxxx - xxx. 40 xxxxxxxxxxxxx jednotek

1e) xxxxxxxx látka xxxxx xxxxxx xxxxxxxxxx X x dětské xxxxxxx:

Xxxxx xxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx X - 10 xxxxxxxxxx

1x) očkovací xxxxx xxxxx virové xxxxxxxxxx B v xxxxxxx xxxxxxx:

Xxxxx xxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx X - 20 xxxxxxxxxx

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

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

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

¹&xxxx;xxxxxxxxx na xxxxxxx xxxxxxxx embryí

² pomnoženo xx lidských xxxxxxxxxxx xxxxxxx (MRC-5)

³ 50% infekční xxxxx xxxxxxx kultury

NEBO

1ga) xxxxxxxx xxxxx proti xxxxxxxxxx, xxxxxxxxxx x xxxxxxxxx

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

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

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

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

* 50 % xxxxxxxx xxxxx xxxxxxx xxxxxxx

¹&xxxx;xxxxxxxx xx xxxxxxx xxxxxxxx embryí.

² vyrobeno na xxxxxxxx xxxxxxxxxxx plicních XX-38 xxxxxxxxxxxxx.

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

Jedna xxxxx (0,5 xx) xxxxxxxx:

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

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

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

^* Kultivováno xx XXXX xxxxxxx

^**&xxxx;Xxxx xxxxxxxx xxxxxxxx xxxx xxxxx xxxxxx xxxx xx, která byla xxxxx xxxxxxxxx jako 40-8-32 D xxxxxxxx xxxxxxxx pro xxxxx xxxx 1, 2 x 3, xxx xxxxxx jinou vhodnou xxxxxxxxxxxxxx xxxxxxx.

1xx) konjugovaná xxxxxxxx látka xxxxx xxxxxxxxxxxxx xxxxxxxx

Xxxxx dávka (0,5 xx) obsahuje:

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

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

xxxxxxxxxxxx bakterie (pneumokoka) Streptococcus xxxxxxxxxx&xxxx;xxxxxxxx 6X^1,2&xxxx;4,4 μx

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

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

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

polysacharid xxxxxxxx (xxxxxxxxxx)&xxxx;Xxxxxxxxxxxxx xxxxxxxxxx&xxxx;xxxxxxxx 10X^1,2&xxxx;2,2 μg

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

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

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

xxxxxxxxxxxx xxxxxxxx (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 μx

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

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

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

xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx)&xxxx;Xxxxxxxxxxxxx pneumoniae sérotypu 23X^1,2&xxxx;2,2 μg

polysacharid bakterie (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 fosforečnan hlinitý (0,125 xx hliníku xx xxxxx)

XXXX

1xxx) konjugovaná xxxxxxxx xxxxx xxxxx xxxxxxxxxxxxx xxxxxxxx

1 dávka (0,5 xx) obsahuje:

Polysacharid xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 3¹ 4 μx

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

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

Polysacharid xxxxxxxx (pneumokoka) Streptococcus xxxxxxxxxx xxxxxxxx 8¹&xxxx;4 μx

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

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

Xxxxxxxxxxxx xxxxxxxx (pneumokoka) Xxxxxxxxxxxxx xxxxxxxxxx sérotypu 11A¹ 4 μx

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

Polysacharid xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx 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 pneumoniae xxxxxxxx 16X¹&xxxx;4 μg

Polysacharid xxxxxxxx (xxxxxxxxxx) Streptococcus xxxxxxxxxx xxxxxxxx 17F¹ 4 μx

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

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

Xxxxxxxxxxxx bakterie (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 22F¹ 4 μx

Xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx sérotypu 23A¹ 4 μx

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

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

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

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

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

^1&xxxx;Xxxxxxxxxx x proteinovým xxxxxxx XXX₁₉₇. CRM₁₉₇ je xxxxxxxxx xxxxxx xxxxxxxxxxxx xxxxxx (xxxxxxxxxxxxx z bakterie Xxxxxxxxxxxxxxx diphtheriae C7) xxxxxxxxxxxxx xxxxxxxxxxx v xxxxxxxx Xxxxxxxxxxx xxxxxxxxxxx.

XXXX

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

1xxxx) xxxxxxxxxxx očkovací xxxxx xxxxxxxx:

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

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

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

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

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 6A^1,2 polysaccharidum 2,0 xxxxxxxxxx

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

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

Streptococci xxxxxxxxxx xxxxxxxx 9V^1,2 polysaccharidum 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 xxxxxxxxxx

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

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

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

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

^1&xxxx;Xxxxxxxxxx x xxxxxxxxxxx xxxxxxx CRM₁₉₇. XXX₁₉₇&xxxx;xx xxxxxxxxx xxxxxx difterického xxxxxx (xxxxxxxxxxxxx x&xxxx;Xxxxxxxxxxxxxxx xxxxxxxxxxx&xxxx;X7) rekombinantně xxxxxxxxxxxxx x&xxxx;Xxxxxxxxxxx fluorescens.

² Adsorbován xx xxxxxxxx fosforečnan xxxxxxx.

X

1xxxx) xxxxxxxxxxxxxxx očkovací xxxxx xxxxxxxx:

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

XXXX

1xxx) xxxxxxxx látky xxxxx xxxxxxxxxxxxx xxxxxxxx xxxxxxxxx v xxxxxxxxxx xxxxxxxx:

1xxxx) konjugovaná očkovací xxxxx xxxxxxxx:

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

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

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

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

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

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

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

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

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

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 23F¹ 2,2 µx

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

X

1xxxx) xxxxxxxxxxxxxxx očkovací xxxxx xxxxxxxx:

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

1x) xxxxxxxx xxxxx xxxxx záškrtu, dávivému xxxxx (xxxxxxxxxx forma), xxxxxx, xxxxxx přenosné xxxxx (inaktivovaná xxxxx):

Xxxxx xxxxx (0,5 xx) xxxxxxxx:

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

Tetani xxxxxxxxxx¹ -^&xxxx;xx xxxx než 20 mezinárodních jednotek (XX) (5 Xx)

Xxxxxxxxxxx xxxxxxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxxx¹ -^&xxxx;8 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxx xxxxxxxxxxxx¹&xxxx;- 8 xxxxxxxxxx

Xxxxxxxxx¹&xxxx;2,5 xxxxxxxxxx

Xxxxx poliomyelitidis inactivatum:

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

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

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

^1&xxxx;xxxxxxxxxxx xx xxxxxxxxxxx xxxxxxxx xxxxxxx (Al(OH)₃) 0,3 xxxxxxxxx Xx^3+&xxxx;x fosforečnan xxxxxxx (XxXX₄) 0,2 xxxxxxxxx Xx³⁺

²&xxxx;xxxxxxxxx xx XXXX xxxxxxx

XXXX

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

Xxxxx xxxxx (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx xxxxxxxxxx xxxxxxxxx 2 IU¹ (2 Xx)

Xxxxxx xxxxxxxxxx xxxxxxxxx 20 IU¹ (5 Xx)

Xxxxxxxxx xxxxxxxx:

Xxxxxxxxx anatoxinum 2,5 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxxxx filamentosum 5 mikrogramů

Pertactinum 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 xxxxxxxx³

xxxxx 3 (Xxxxxxx) 26 X xxxxxxxx xxxxxxxx³

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

^1&xxxx;Xxxx xxxxxx xxxxxxx xxxxxxxxx xxxxxxxxxxxxx (x = 0,95) xxxxxxxx měřené xxxxx xxxxx xxxxxxxxx v Xxxxxxxxx lékopisu.

²  Kultivováno xx Xxxx xxxxxxx.

^3&xxxx;&xxxx;Xxxx xxxxxxxx xxxxxxxx xxxx xxxxx xxxxxx jako xx, xxxxx xxxx xxxxx xxxxxxxxx xxxx 40-8-32 X xxxxxxxx antigenu xxx xxxxx typu 1, 2 x 3, xxx xxxxxx xxxxx xxxxxxx imunochemickou xxxxxxx.

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

** Xxxxxxxxxxx xx Vero xxxxxxx.

1x) xxxxxxxx látka xxxxx xxxxxxxxxxx (XXX xxxxxxx)

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

Jedna xxxxx (0,5 xx) xxxxxxx xxxxxxxx:

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

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

²&xxxx;xxxxxxxxxxx na xxxxxxxxxxx hlinitý (xxxxxx 0,5 miligramu Xx³⁺)

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

2. Antigenní xxxxxxx xxxxxxxxxx xxxxx pro xxxxxxxx xxxxxxxx

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

Xxxxx xxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx B - 20 xxxxxxxxxx

2x) xxxxxxxx xxxxx xxxxx xxxxxxxxx

2x) xxxxxxxx xxxxx xxxxx xxxxxx xxxxxxxxxx X xx xxxxxxx xxx xxxxxxx:

Xxxxx dávka obsahuje:

Hepatitis X xxxxx xxxxxxxxxxx

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

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

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

Parotitidis 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 buňkách xxxxxxxx xxxxxx

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

³&xxxx;50% xxxxxxxx dávka xxxxxxx xxxxxxx

XXXX

2xx) xxxxxxxx xxxxx xxxxx spalničkám, xxxxxxxxxx x xxxxxxxxx

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

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

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

Xxxxx rubeolae² vivum xxxxxxxxxx (kmen Xxxxxx XX 27/3) ne xxxx xxx 1x10³&xxxx;XXXX₅₀*

* 50% infekční xxxxx xxxxxxx xxxxxxx

¹&xxxx;xxxxxxxx xx xxxxxxx xxxxxxxx xxxxxx.

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

3. Xxxxxxxxx složení xxxxxxxxxx xxxxx xxx xxxxxxxxx xxxxxxxx

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

Xxxxx xxxxxxxxx X xxxxxxxxxxx

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

Virus xxxxxxxxx X xxxxxxxxxxx

3x) xxxxxxxx látka proti xxxxxxxxxx, xxxxxxxxxx x xxxxxxxxx:

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

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

Xxxxxxxxxxx xxxxx xxxxxxxxxx¹&xxxx;(XXX 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 buňkách xxxxxxxx embryí

² pomnoženo na xxxxxxxx xxxxxxxxxxx xxxxxxx (XXX-5)

³&xxxx;50% xxxxxxxx dávka xxxxxxx xxxxxxx

XXXX

3xx) xxxxxxxx xxxxx proti xxxxxxxxxx, xxxxxxxxxx x xxxxxxxxx

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

Xxxxx xxxxxxxxxxx¹&xxxx;xxxxx xxxxxxxxxx (kmen Xxxxxx’ Xxxxxxxxx) 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 (xxxx Xxxxxx XX 27/3) xx xxxx než 1x110³ CCID₅₀*

* 50% infekční xxxxx xxxxxxx xxxxxxx

¹&xxxx;xxxxxxxx xx xxxxxxx xxxxxxxx embryí.

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

Xxxxxxx:

xxxx. XXXx. Xxxxx, XXx., XXX, EBIR, x. x.

Informace

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

Xx xxx xxxxxxxx xxxxxx xxxxxxx xxxxx xxxxx xx xxxxxxxxx.

Xxxxx xxxxxxxxxxxx xxxxxxxx xxxxx xxxxxx xxxxxxxx předpisů x xxxxxxxx xxxx aktualizováno, xxxxx se jich xxxxxx derogační xxxxx xxxxx xxxxxxxxx právního xxxxxxxx.