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 dne 10. prosince 2025

o xxxxxxxxxx xxxxxxx xxxxxxxxxx xxxxx xxx pravidelná, xxxxxxxx a xxxxxxxxx xxxxxxxx xxx xxx 2026
&xxxx;

Xxxxxxxxxxxx xxxxxxxxxxxxx xxxxx §80 odst. 1 xxxx. e) xxxxxx x. 258/2000 Xx., x xxxxxxx veřejného xxxxxx x o xxxxx xxxxxxxxx souvisejících xxxxxx, xx xxxxx xxxxxxxxxx xxxxxxxx, stanoví xx základě doporučení Xxxxxxx xxxxxxxxxx xxxxxx xxxxxxxxx složení očkovacích xxxxx xxx pravidelná, xxxxxxxx x mimořádná xxxxxxxx pro xxx 2026:

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

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

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

Xxxxxxxxxxx anatoxinum¹ ne xxxx xxx 30 xxxxxxxxxxxxx xxxxxxxx (IU)

Tetani anatoxinum¹ ne xxxx než 40 xxxxxxxxxxxxx xxxxxxxx (XX)

Xxxxxxxx&xxxx;Xxxxxxxxxx xxxxxxxxx:

Xxxxxxxxx anatoxinum (XX)¹&xxxx;25 xxxxxxxxxx

Xxxxxxxxx haemagglutininum filamentosum (XXX)¹&xxxx;25 mikrogramů

Pertactinum (PRN)¹ 8 xxxxxxxxxx

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

Virus xxxxxxxxxxxxxxx inactivatum (IPV)

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

typus 2 (xxxx MEF-1)⁴ 8 X jednotek xxxxxxxx

xxxxx 3 (kmen Saukett)⁴ 32 X xxxxxxxx xxxxxxxx

Xxxxxxxxxxx xxxxxxxxxx xxxxx&xxxx;x xxxxxxxxxxxxxxx

(Xxxxxxxxxxxxxxxxxxx xxxxxxxx) 10 mikrogramů

conj. xxx xxxxxx. xxxxxxxx xxxx nosný xxxxxxx xxxxxxxxx 25 mikrogramů

¹ adsorbováno xx xxxxxxxx xxxxxxx, xxxxxxxxxxx (Al(OH)₃) 0,5 xxxxxxxxx Xx³⁺

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

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

⁴&xxxx;xxxxxxxxx xx XXXX xxxxxxx

XXXX

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

Xxxxx xxxxx¹&xxxx;(0,5 ml) xxxxxxxx:

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

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

Xxxxxxxx Xxxxxxxxxx pertussis

Pertussis xxxxxxxxxx 25 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxxxx xxxxxxxxxxxx 25 mikrogramů

Virus Xxxxxxxxxxxxxxx (inaktivovaný)⁵

typus 1 (Xxxxxxx) 29 D xxxxxxxx antigenu⁶

typus 2 (XXX-1) 7 X xxxxxxxx xxxxxxxx⁶

xxxxx 3 (Xxxxxxx) 26 X xxxxxxxx xxxxxxxx⁶

Xxxxxxxxx xxxxxxxxxxx X antigenum⁷ 10 xxxxxxxxxx

Xxxxxxxxxx xxxxxxxxxx xxxx X xxxxxxxxxxxxxxx (Xxxxxxxxxxxxxxxxxxx phosphas) 12 xxxxxxxxxx

xxxxxxxxxx xxx xxxxxx proteino 22-36 xxxxxxxxxx

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

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

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

⁴ Nebo ekvivalentní xxxxxxxx xxxxxxxxx xxxxxxxxxx xxxxxxxxxxx

^5&xxxx;Xxxxxxxxxxx xx Vero xxxxxxx

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

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

XXXX

1xx) Xxxxxxx xxxxx xxxxxxx, xxxxxx, xxxxxxxx xxxxx (xxxxxxxxxx xxxxxxxxxx), hepatitidě X (xXXX), dětské xxxxxxxx xxxxx (xxxxxxxxxxxx) x xxxxxxxxxxx xxxxxxx proti Xxxxxxxxxxx xxxx x (xxxxxxxxxxx)

Xxxxx xxxxx (0,5 xx) obsahuje:

Diphtheriae xxxxxxxxxx¹ xx méně než 20 XX⁶

Xxxxxx xxxxxxxxxxˡ xx méně xxx 40 XX⁶

Xxxxxxxx&xxxx;Xxxxxxxxxxx xxxxxxxx¹

Xxxxxxxxx xxxxxxxxxx (PT) 20 xxxxxxxxxx

Xxxxxxxxxxxxxxx xxxxxxxxxxxx (XXX) 20 mikrogramů

Pertactinum (XXX) 3 xxxxxxxxxx

Xxxxxxxx xxxx 2 xx 3 (XXX) 5 xxxxxxxxxx

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

Xxxxx poliomyelitidis (inactivatum)⁴

Typus 1 (Xxxxxxx) 40 X xxxxxxxx xxxxxxxx⁵

Xxxxx 2 (XXX-1) 8 X xxxxxxxx xxxxxxxx⁵

Xxxxx 3 (Xxxxxxx) 32 X xxxxxxxx xxxxxxxx⁵

Xxxxxxxxxxxxxx Xxxxxxxxxx xxxxxxxxxx&xxxx;xxxxx b

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

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

²&xxxx;xxxxxxxxxxx xx hydratovaný xxxxxxxx hlinitý xxxxxx (0,15 xx Al³⁺)

³ vyrobeno xxxxxxxxxxxxx DNA technologií x kvasinkových xxxxxxx&xxxx;Xxxxxxxxxxxxx xxxxxxxxxx

⁴&xxxx;xxxxxxxxx xx Vero xxxxxxx

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

⁶&xxxx;xxxx ekvivalentní xxxxxxxx xxxxxxxxx xxxxxxxxxxxx xxxxxxxxxxx

1x) očkovací látka xxxxx xxxxxxx, dávivému xxxxx (xxxxxxxxxx forma), xxxxxx (DTaP)

Jedna dávka (0,5 xx) xxxxxxxx xxxx léčivé xxxxx:

Xxxxxxxxxxx xxxxxxxxxx* ≥ 30 XX

Xxxxxx xxxxxxxxxx* ≥ 40 IU

Pertussis xxxxxxxxxx* (XX) 25 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxxxxx* (XXX) 25 xxxxxxxxxx

Xxxxxxxxxxx* (69xX) 8 xxxxxxxxxx

* adsorbováno xx xxxxxxxx xxxxxxx xxxxxx: 0,5 xxxxxxxxx

XXXX

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

Xxxxx dávka (0,5 ml) obsahuje:

Diphtheriae xxxxxxxxxx - Xxxxxxxxx 2 IU* (2 Xx)

Xxxxxx xxxxxxxxxx - Xxxxxxxxx 20 IU* (5 Xx)

Xxxxxxxxx xxxxxxxx

Xxxxxxxxx xxxxxxxxxx - 2,5 xxxxxxxxxx

Xxxxxxxxxxxxxx xxxxxxxxxxxx - 5 xxxxxxxxxx

Xxxxxxxxxxx - 3 mikrogramy

Fimbriae, xxxx 2 xx 3 - 5 xxxxxxxxxx

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

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

XXXX

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

Xxxxx xxxxx (0,5 xx) obsahuje:

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

Tetani xxxxxxxxxx¹&xxxx;xx xxxx než 20 xxxxxxxxxxxxx xxxxxxxx (IU) (5 Lf)

Bordetellae xxxxxxxxx xxxxxxxx:

Xxxxxxxxx anatoxinum¹ 8 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxx filamentosum¹ 8 xxxxxxxxxx

Xxxxxxxxxxx¹&xxxx;2,5 xxxxxxxxxx

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

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

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

Xxxxxxxxxxx xxxxxxxxxx xxxxx x xxxxxxxxxxxxxxx 10 xxxxxxxxxx

xxxxxxxxxxx x xxxxxxxxxx toxoidem 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 tegiminis xxxxxxxxxxx X - 10 xxxxxxxxxx

1x) xxxxxxxx xxxxx xxxxx virové xxxxxxxxxx B x xxxxxxx xxxxxxx:

Xxxxx dávka xxxxxxxx:

Xxxxxxxxx xxxxxxxxx hepatitidis X - 20 xxxxxxxxxx

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

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

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

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

Xxxxxxxx xxxxx xxxxxxxxxx^2&xxxx;(Xxxxxx XX 27/3) xxx. 10^3,0&xxxx;xxxxxxxx dávka xxx xxxxxxxx kulturu₅₀³

¹ pomnoženo xx xxxxxxx xxxxxxxx xxxxxx

²&xxxx;xxxxxxxxx xx lidských xxxxxxxxxxx xxxxxxx (MRC-5)

³ 50% infekční xxxxx xxxxxxx xxxxxxx

XXXX

1xx) xxxxxxxx látka proti xxxxxxxxxx, příušnicím a xxxxxxxxx

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

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

Xxxxx xxxxxxxxxxx¹&xxxx;xxxxx xxxxxxxxxx (xxxx Xxxxx Xxxx™, xxxxxxx B) ne xxxx než 12,5x10³&xxxx;XXXX₅₀*

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

* 50 % xxxxxxxx dávka xxxxxxx xxxxxxx

¹&xxxx;xxxxxxxx na buňkách xxxxxxxx xxxxxx.

²&xxxx;xxxxxxxx na xxxxxxxx diploidních xxxxxxxx XX-38 fibroblastech.

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

Jedna dávka (0,5 xx) obsahuje:

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

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

Xxxxx xxxxxxxxxxxxx xxxxxxxxxxx typus 3 (Xxxxxxx) ……. 26 xxxxxxxxxxx D jednotek**

^* Kultivováno xx XXXX xxxxxxx

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

1xx) konjugovaná xxxxxxxx xxxxx xxxxx xxxxxxxxxxxxx xxxxxxxx

Xxxxx xxxxx (0,5 ml) xxxxxxxx:

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

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

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

polysacharid xxxxxxxx (xxxxxxxxxx)&xxxx;Xxxxxxxxxxxxx pneumoniae sérotypu 5^1,2&xxxx;2,2 μx

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

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

polysacharid xxxxxxxx (pneumokoka) Streptococcus 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 (pneumokoka) Streptococcus xxxxxxxxxx&xxxx;xxxxxxxx 9X^1,2&xxxx;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 (xxxxxxxxxx)&xxxx;Xxxxxxxxxxxxx xxxxxxxxxx&xxxx;xxxxxxxx 12X^1,2&xxxx;2,2 μx

xxxxxxxxxxxx xxxxxxxx (pneumokoka) Streptococcus xxxxxxxxxx&xxxx;xxxxxxxx 14^1,2&xxxx;2,2 μg

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

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

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

^1&xxxx;Xxxxxxxxxx x nosným xxxxxxxxx CRM₁₉₇ (přibližně 51 μx na xxxxx)

²&xxxx;Xxxxxxxxxx xx fosforečnan hlinitý (0,125 xx hliníku xx xxxxx)

XXXX

1xxx) konjugovaná xxxxxxxx xxxxx xxxxx xxxxxxxxxxxxx infekcím

1 xxxxx (0,5 ml) obsahuje:

Polysacharid xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx sérotypu 3¹ 4 μx

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

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

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

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

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

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

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

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

Xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Streptococcus xxxxxxxxxx x deOAc15B (xx-X-xxxxxxxxxxx xxxxxxx 15B)¹ 4 μx

Xxxxxxxxxxxx xxxxxxxx (pneumokoka) Xxxxxxxxxxxxx pneumoniae xxxxxxxx 16X¹&xxxx;4 μg

Polysacharid bakterie (xxxxxxxxxx) Streptococcus xxxxxxxxxx xxxxxxxx 17X¹&xxxx;4 μg

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

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

Polysacharid xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 22F¹ 4 μx

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

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

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

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

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

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

^1&xxxx;Xxxxxxxxxx x xxxxxxxxxxx nosičem XXX₁₉₇. XXX₁₉₇&xxxx;xx xxxxxxxxx xxxxxx xxxxxxxxxxxx toxinu (xxxxxxxxxxxxx x xxxxxxxx Xxxxxxxxxxxxxxx xxxxxxxxxxx C7) xxxxxxxxxxxxx xxxxxxxxxxx x xxxxxxxx Xxxxxxxxxxx xxxxxxxxxxx.

XXXX

1xxx) xxxxxxxx xxxxx xxxxx xxxxxxxxxxxxx infekcím xxxxxxxxx x sekvenčním xxxxxxxx:

1xxxx) 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 mikrogramů

Streptococci xxxxxxxxxx xxxxxxxx 4^1,2 polysaccharidum 2,0 xxxxxxxxxx

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

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

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

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

Xxxxxxxxxxxx xxxxxxxxxx serotypi 9X^1,2&xxxx;xxxxxxxxxxxxxxx 2,0 mikrogramů

Streptococci xxxxxxxxxx xxxxxxxx 14^1,2 polysaccharidum 2,0 xxxxxxxxxx

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

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

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

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

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

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

^1&xxxx;Xxxxxxxxxx s proteinovým xxxxxxx CRM₁₉₇. XXX₁₉₇&xxxx;xx xxxxxxxxx mutace difterického xxxxxx (pocházejícího z Corynebacterium xxxxxxxxxxx&xxxx;X7) rekombinantně xxxxxxxxxxxxx x&xxxx;Xxxxxxxxxxx fluorescens.

² Adsorbován na xxxxxxxx xxxxxxxxxxx hlinitý.

A

1chbb) xxxxxxxxxxxxxxx xxxxxxxx látka xxxxxxxx:

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

XXXX

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

1xxxx) xxxxxxxxxxx xxxxxxxx xxxxx xxxxxxxx:

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

Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum xxxxxxxxx 3¹ 2,2 µg

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

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

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 6A¹ 2,2 µx

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

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

Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum xxxxxxxxx 9V¹ 2,2 µx

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

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

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

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

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

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

X

1xxxx) xxxxxxxxxxxxxxx xxxxxxxx xxxxx xxxxxxxx:

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

1x) xxxxxxxx látka xxxxx záškrtu, xxxxxxxx xxxxx (acelulární xxxxx), xxxxxx, xxxxxx xxxxxxxx xxxxx (xxxxxxxxxxxx xxxxx):

Xxxxx xxxxx (0,5 ml) xxxxxxxx:

Xxxxxxxxxxx anatoxinum¹ - xx xxxx než 2 xxxxxxxxxxx xxxxxxxx (XX) (2,5 Lf)

Tetani anatoxinum¹ -^&xxxx;xx xxxx xxx 20 xxxxxxxxxxxxx xxxxxxxx (XX) (5 Lf)

Bordetellae xxxxxxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxxx¹ -^&xxxx;8 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxx xxxxxxxxxxxx¹&xxxx;- 8 xxxxxxxxxx

Xxxxxxxxx¹&xxxx;2,5 xxxxxxxxxx

Xxxxx poliomyelitidis xxxxxxxxxxx:

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

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

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

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

²&xxxx;xxxxxxxxx xx XXXX buňkách

NEBO

1ia) xxxxxxxx xxxxx xxxxx záškrtu, xxxxxxxx xxxxx (acelulární xxxxx), xxxxxx, xxxxxx xxxxxxxx xxxxx (xxxxxxxxxxxx xxxxx):

Xxxxx dávka (0,5 xx) obsahuje:

Diphtheriae xxxxxxxxxx xxxxxxxxx 2 IU¹ (2 Xx)

Xxxxxx xxxxxxxxxx xxxxxxxxx 20 XX¹&xxxx;(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 xxxxxxxxxxxxxxx (xxxxxxxxxxx)²

xxxxx 1 (Mahoney) 29 X xxxxxxxx xxxxxxxx³

xxxxx 2 (XXX1) 7 X xxxxxxxx xxxxxxxx³

xxxxx 3 (Xxxxxxx) 26 X xxxxxxxx xxxxxxxx³

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

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

²  Kultivováno xx Xxxx xxxxxxx.

^3&xxxx;&xxxx;Xxxx množství xxxxxxxx jsou úplně xxxxxx xxxx ta, xxxxx xxxx xxxxx xxxxxxxxx xxxx 40-8-32 X jednotek xxxxxxxx xxx xxxxx xxxx 1, 2 x 3, xxx xxxxxx xxxxx vhodnou imunochemickou xxxxxxx.

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

** Xxxxxxxxxxx xx Vero xxxxxxx.

1x) xxxxxxxx xxxxx xxxxx xxxxxxxxxxx (BCG xxxxxxx)

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

Xxxxx dávka (0,5 ml) xxxxxxx xxxxxxxx:

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

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

² adsorbovaný xx xxxxxxxxxxx hlinitý (xxxxxx 0,5 xxxxxxxxx Al³⁺)

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

2. Antigenní xxxxxxx xxxxxxxxxx látek xxx xxxxxxxx xxxxxxxx

2x) xxxxxxxx xxxxx proti xxxxxx xxxxxxxxxx X ve xxxxxxx pro xxxxxxx:

Xxxxx xxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx B - 20 xxxxxxxxxx

2x) xxxxxxxx xxxxx xxxxx vzteklině

2c) xxxxxxxx xxxxx proti xxxxxx xxxxxxxxxx X xx xxxxxxx pro xxxxxxx:

Xxxxx xxxxx obsahuje:

Hepatitis X xxxxx xxxxxxxxxxx

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

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

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

Parotitidis xxxxx attenuatum¹ (RIT 4385) xxx. 10^3,7 infekční xxxxx xxx buněčnou kulturu₅₀³

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

¹&xxxx;xxxxxxxxx xx xxxxxxx xxxxxxxx xxxxxx

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

³&xxxx;50% xxxxxxxx xxxxx xxxxxxx xxxxxxx

XXXX

2xx) xxxxxxxx xxxxx xxxxx xxxxxxxxxx, xxxxxxxxxx x xxxxxxxxx

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

Xxxxx xxxxxxxxxxx¹&xxxx;xxxxx attenuatum (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 xxx 1x10³ CCID₅₀*

* 50% infekční dávka xxxxxxx xxxxxxx

¹&xxxx;xxxxxxxx na xxxxxxx xxxxxxxx xxxxxx.

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

3. Xxxxxxxxx složení očkovacích xxxxx xxx xxxxxxxxx xxxxxxxx

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

Xxxxx xxxxxxxxx X inactivatum

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

Xxxxx xxxxxxxxx X xxxxxxxxxxx

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

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

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

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

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

¹&xxxx;xxxxxxxxx xx buňkách xxxxxxxx xxxxxx

²&xxxx;xxxxxxxxx na 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 ml):

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

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

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

* 50% xxxxxxxx xxxxx xxxxxxx xxxxxxx

¹&xxxx;xxxxxxxx xx xxxxxxx xxxxxxxx xxxxxx.

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

Ministr:

prof. XXXx. Xxxxx, CSc., XXX, EBIR, x. x.

Xxxxxxxxx

Xxxxxx xxxxxxx č. 528/2025 Sb. xxxxx xxxxxxxxx xxxx 12.12.2025.

Xx xxx xxxxxxxx xxxxxx xxxxxxx xxxxx měněn xx doplňován.

Znění xxxxxxxxxxxx xxxxxxxx xxxxx xxxxxx xxxxxxxx xxxxxxxx v xxxxxxxx xxxx aktualizováno, xxxxx xx jich xxxxxx derogační změna xxxxx xxxxxxxxx právního xxxxxxxx.