Plné znění - 420/2023 Sb.

Sdělení Ministerstva zdravotnictví o antigenním složení očkovacích látek pro pravidelná, zvláštní a mimořádná očkování pro rok 2024

420/2023 Sb.
 

Sdělení Ministerstva zdravotnictví

INFORMACE

420

XXXXXXX

Xxxxxxxxxxxx xxxxxxxxxxxxx

xx xxx 19. xxxxxxxx 2023

x xxxxxxxxxx složení xxxxxxxxxx xxxxx pro xxxxxxxxxx, xxxxxxxx a mimořádná xxxxxxxx xxx xxx 2024
&xxxx;

Xxxxxxxxxxxx zdravotnictví podle §80 odst. 1 xxxx. e) xxxxxx x. 258/2000 Xx., x xxxxxxx veřejného xxxxxx x x xxxxx xxxxxxxxx xxxxxxxxxxxxx xxxxxx, xx znění xxxxxxxxxx předpisů, stanoví xx základě xxxxxxxxxx Xxxxxxx xxxxxxxxxx xxxxxx xxxxxxxxx xxxxxxx očkovacích xxxxx xxx xxxxxxxxxx, xxxxxxxx x mimořádná xxxxxxxx pro rok 2024:

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

1x)&xxxx;xxxxxxxxxxx očkovací xxxxx xxxxx xxxxxxx, xxxxxxxx xxxxx (xxxxxxxxxx xxxxx), xxxxxx, xxxxxx xxxxxxxx xxxxx (inaktivovaná xxxxx), xxxxxx xxxxxxxxxx B, xxxxxxx vyvolaným Xxxxxxxxxxx xxxxxxxxxx xxx x (XXxXXxxXXXXXX)

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

Xxxxxxxxxxx anatoxinum¹ ne xxxx xxx 30 xxxxxxxxxxxxx xxxxxxxx (XX)

Xxxxxx anatoxinum¹ ne xxxx xxx 40 xxxxxxxxxxxxx xxxxxxxx (XX)

Xxxxxxxx Xxxxxxxxxx xxxxxxxxx:

Xxxxxxxxx anatoxinum (XX)¹&xxxx;25 mikrogramů

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

Pertactinum (XXX)¹&xxxx;8 xxxxxxxxxx

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

Xxxxx xxxxxxxxxxxxxxx xxxxxxxxxxx (XXX)

xx pus 1 (xxxx Xxxxxxx)^4&xxxx;40 D xxxxxxxx antigenu

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

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

Haemophilus xxxxxxxxxx xxxxx x polysaccharidum

(Polyribosylribitoli xxxxxxxx) 10 xxxxxxxxxx

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

¹&xxxx;xxxxxxxxxxx xx xxxxxxxx xxxxxxx, xxxxxxxxxxx (Al(OH)₃) 0,5 xxxxxxxxx Al³⁺

² vyrobeno xxxxxxxxxxxxx XXX technologií na xxxxxxx xxxxxxxxxxxx xxxxx (Xxxxxxxxxxxxx cerevisiae)

³ adsorbováno xx xxxxxxxxxxx xxxxxxx (AlPO₄) 0,32 xxxxxxxxx Xx³⁺

⁴&xxxx;xxxxxxxxx xx VERO xxxxxxx

XXXX

1xx)&xxxx;xxxxxxxxxxx xxxxxxxx látka xxxxx xxxxxxx, xxxxxxxx kašli (xxxxxxxxxx xxxxx), xxxxxx, xxxxxx přenosné xxxxx (xxxxxxxxxxxx forma), xxxxxx xxxxxxxxxx X, nákazám xxxxxxxxx Xxxxxxxxxxx xxxxxxxxxx xxx b (DTaPHibVHBIPV)

Jedna xxxxx¹&xxxx;(0,5 xx) xxxxxxxx:

Xxxxxxxxxxx xxxxxxxxxx ne méně xxx 20 xxxxxxxxxxxxx xxxxxxxx (IU)²

Tetani xxxxxxxxxx xx xxxx než 40 xxxxxxxxxxxxx xxxxxxxx (XX)²

Xxxxxxxx Xxxxxxxxxx xxxxxxxxx

Xxxxxxxxx xxxxxxxxxx 25 xxxxxxxxxx

Xxxxxxxxxxxxxx xxxxxxxxxxxx 25 xxxxxxxxxx

Xxxxx Xxxxxxxxxxxxxxx (xxxxxxxxxxxx)³

xxxxx 1 (Xxxxxxx) 40 D xxxxxxxx xxxxxxxx⁴

xx xxx 2 (MEF-1) 8 X xxxxxxxx antigenu⁴

typus 3 (Xxxxxxx) 32 X xxxxxxxx xxxxxxxx⁴

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx X⁵&xxxx;10 xxxxxxxxxx

Xxxxxxxxxxxxxxxxxxx xxxxxxxx xxxxxxxxxx xxxxxxxxxx X 12 xxxxxxxxxx

(Xxxxxxxxxxxxxxxxxxx xxxxxxxx)

xxxxxxxxx xxx xxxxxx xxxxxxxxxx 22-36 xxxxxxxxxx

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

²&xxxx;xxxx xxxxxx xxx xxxxxxxxxxxxx (x = 0,95)

³ pomnoženo xx XXXX buňkách

⁴ nebo xxxxxxxxxxxx xxxxxxxx antigenu xxxxxxxxx xxxxxxx xxxxxxxxxxxxxx xxxxxxx

⁵&xxxx;xxxxxxxx xxxxxxxxxxxxx XXX technologií x xxxxxxxxxxxx xxxxxxx Xxxxxxxxx xxxxxxxxxx

XXXX

1xx)&xxxx;Xxxxxxx xxxxx xxxxxxx, tetanu, xxxxxxxx xxxxx (xxxxxxxxxx xxxxxxxxxx), xxxxxxxxxx X (xXXX), xxxxxx přenosné xxxxx (xxxxxxxxxxxx) a konjugovaná xxxxxxx xxxxx Haemophilus xxxx b (xxxxxxxxxxx)

Xxxxx xxxxx (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx xxxxxxxxxx¹&xxxx;xx xxxx xxx 20 IU

Tetani xxxxxxxxxx¹&xxxx;xx méně než 40 XX

Xxxxxxxx Xxxxxxxxxxx xxxxxxxx¹

Xxxxxxxxx xxxxxxxxxx (XX) 20 xxxxxxxxxx

Xxxxxxxxxxxxxxx xxxxxxxxxxxx (XXX) 20 xxxxxxxxxx

Xxxxxxxxxxx (XXX) 3 xxxxxxxxxx

Xxxxxxxx xxxx 2 et 3 (FIM) 5 xxxxxxxxxx

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

Xxxxx xxxxxxxxxxxxxxx (xxxxxxxxxxx)⁴

Xxxxx 1 (Xxxxxxx) 40 X jednotek xxxxxxxx⁵

Xxxxx 2 (XXX-1) 8 D xxxxxxxx xxxxxxxx⁵

Xxxxx 3 (Xxxxxxx) 32 D jednotek xxxxxxxx⁵

Xxxxxxxxxxxxxx Xxxxxxxxxx xxxxxxxxxx xxxxx x

(Xxxxxxxxxxxxxxxxxxx xxxxxxxx) 3 xxxxxxxxxx xxxxxxxxxx xxx xxxxxxxxx meningococci xxxxx b² 50 mikrogramů

¹ adsorbováno xx xxxxxxxxxxx xxxxxxx (0,17 mg Al³⁺)

² adsorbováno xx hydratovaný xxxxxxxx xxxxxxx xxxxxx (0,15 xx Al³⁺)

³ vyrobeno rekombinantní XXX xxxxxxxxxxx v xxxxxxxxxxxx xxxxxxx Xxxxxxxxxxxxx xxxxxxxxxx

⁴&xxxx;xxxxxxxxx xx Vero xxxxxxx

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

1x)&xxxx;xxxxxxxx xxxxx xxxxx xxxxxxx, dávivému xxxxx (xxxxxxxxxx forma), xxxxxx (DTaP)

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

Xxxxxxxxxxx xxxxxxxxxx* ≥ 30 XX

Xxxxxx xxxxxxxxxx* ≥ 40 IU

Pertussis xxxxxxxxxx* (XX) 25 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxxx filamentosum* (FHA) 25 xxxxxxxxxx

Xxxxxxxxxxx* (69xX) 8 mikrogramů

* adsorbováno na xxxxxxxx xxxxxxx xxxxxx: 0,5 miligramů

NEBO

1ba) Očkovací látka xxxxx xxxxxxx, tetanu x xxxxxxxx xxxxx (xxxxxxxxxx) xx xxxxxxxx xxxxxxx xxxxxxxx (Xxxx)

Xxxxx xxxxx (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx xxxxxxxxxx - Xxxxxxxxx 2 XX* (2 Xx)

Xxxxxx xxxxxxxxxx - Xxxxxxxxx 20 XX* (5 Xx)

Xxxxxxxxx xxxxxxxx

Xxxxxxxxx anatoxinum - 2,5 xxxxxxxxxx

Xxxxxxxxxxxxxx xxxxxxxxxxxx - 5 xxxxxxxxxx

Xxxxxxxxxxx - 3 xxxxxxxxxx

Xxxxxxxx, xxxx 2 et 3 - 5 xxxxxxxxxx

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

*&xxxx;Xxxx spodní xxxxxxx xxxxxxxxx xxxxxxxxxxxxx (x = 0,95) xxxxxxxx xxxxxx podle testu xxxxxxxxx x Evropském xxxxxxxx.

XXXX

1xx)&xxxx;Xxxxxxxx xxxxx xxxxx xxxxxxx, xxxxxx x xxxxxxxx kašli (xxxxxxxxxx xxxxxxxxxx) xx xxxxxxxx xxxxxxx xxxxxxxx (Xxxx)

Xxxxx xxxxx (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx anatoxinum¹ ne xxxx xxx 2 xxxxxxxxxxx xxxxxxxx (IU) (2,5 Xx)

Xxxxxx xxxxxxxxxx¹&xxxx;xx xxxx xxx 20 mezinárodních xxxxxxxx (XX) (5 Xx)

Xxxxxxxxxxx xxxxxxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxxx¹&xxxx;8 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxx xxxxxxxxxxxx¹&xxxx;8 mikrogramu

Pertussis xxxxxxxxx xxxxxxxx xxxxxxxxx¹&xxxx;2,5 xxxxxxxxxx

¹&xxxx;xxxxxxxxxxx xx hydratovaný hydroxid xxxxxxx (Xx(XX)₃) 0,3 xxxxxxxxx Xx^3+&xxxx;x xxxxxxxxxxx xxxxxxx (AIPO₄) 0,2 xxxxxxxxx Xx³⁺

1x)&xxxx;xxxxxxxx látka xxxxx xxxxxxx xxxxxxxxx Xxxxxxxxxxx influenzae xxx x:

Xxxxx dávka xxxxxxxxxxxxx xxxxxxx xxxxxxxx:

Xxxxxxxxxxxxxxx Hib xxxxxxxxxxx (10 mikrogramu) xxx Anatoxino tetanico (xxxxxxxxx 25 xxxxxxxxxx).

1x)&xxxx;xxxxxxxx xxxxx xxxxx tetanu:

Jedna xxxxx xxxxxxxx:

Xxxxxx xxxxxxxxxx - xxx. 40 xxxxxxxxxxxxx jednotek

1e) očkovací xxxxx xxxxx xxxxxx xxxxxxxxxx X v xxxxxx xxxxxxx:

Xxxxx xxxxx obsahuje:

Antigenum xxxxxxxxx hepatitidis B - 10 mikrogramu

1f) očkovací xxxxx xxxxx xxxxxx xxxxxxxxxx X x xxxxxxx xxxxxxx

Xxxxx dávka xxxxxxxx:

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx X - 20 xxxxxxxxxx

1x)&xxxx;xxxxxxxx xxxxx xxxxx xxxxxxxxxx, příušnicím x xxxxxxxxx:

Xxxxx xxxxx obsahuje:

Morbillorum 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 virus xxxxxxxxxx²&xxxx;(Xxxxxx RA 27/3) xxx. 10^3,0&xxxx;xxxxxxxx xxxxx xxx xxxxxxxx xxxxxxx₅₀³

¹&xxxx;xxxxxxxxx xx xxxxxxx xxxxxxxx xxxxxx

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

³&xxxx;50% xxxxxxxx xxxxx tkáňové xxxxxxx

XXXX

1xx)&xxxx;xxxxxxxx xxxxx xxxxx xxxxxxxxxx, příušnicím x xxxxxxxxx

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

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

Xxxxx parotitidis¹ vivum xxxxxxxxxx (xxxx Xxxxx Xxxx™, xxxxxxx X) xx xxxx xxx 12,5x10³&xxxx;XXXX₅₀*

Xxxxx xxxxxxxx²&xxxx;xxxxx xxxxxxxxxx (kmen Xxxxxx XX 27/3) xx xxxx xxx 1x10³&xxxx;XXXX₅₀*

*&xxxx;50% xxxxxxxx dávka xxxxxxx kultury

¹ vyrobeno na xxxxxxx xxxxxxxx xxxxxx.

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

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

Jedna xxxxx xxxxxxxx:

Xxxxx xxxxxxxxxxxxx xxxxxxxxxxx xxxxx 1 (Xxxxxxx) ..... 40 xxxxxxxxxxx X xxxxxxxx*

Xxxxx xxxxxxxxxxxxx xxxxxxxxxxx xxxxx 2 (XXX-1) .......... 8 xxxxxxxxxxx X jednotek*

Virus xxxxxxxxxxxxx inactivatum xxxxx 3 (Xxxxxxx) ........ 32 xxxxxxxxxxx D xxxxxxxx*

*&xxxx;xxxx xxxxxxxx xxxxxxxxxxxxxx xxxxxxxx xxxxxxxxx pomocí xxxxxx imunochemické xxxxxx.

1xx)&xxxx;xxxxxxxx xxxxx xxxxx xxxxxxxxxxxxx xxxxxxxx xxxxxxxxx x xxxxxxxxxx schématu:

1cha) konjugovaná očkovací xxxxx xxxxxxxx:

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 1^l 2,2 μx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 3¹ 2,2 μx

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

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

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

Xxxxxxxxxxxx xxxxxxxxxx polysaecharidum sérotypus 6X¹&xxxx;4,4 μg

Streptococci pneumoniae xxxxxxxxxxxxxxx sérotypus 7F¹ 2,2 μx

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

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

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 18C¹ 2,2 μx

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

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

Streptococci pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 23X¹&xxxx;2,2 μx

¹ Xxxxxxxxxx s xxxxxx xxxxxxxxx XXX197 x xxxxxxxxxx xx xxxxxxxxxxx xxxxxxx (0,125 xx xxxxxxx).

X

1xxx)&xxxx;xxxxx xxxxxxxxxxxxx xxxxxxxx

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

XXXX

1xxx)&xxxx;xxxxxxxxxxx očkovací xxxxx xxxxx pneumokokovým xxxxxxxx

Xxxxx xxxxx (0,5 xx) xxxxxxxx:

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

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

xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Streptococcus xxxxxxxxxx sérotypu 4 ^1,2 2,2 μx

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

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

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

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

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

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

xxxxxxxxxxxx bakterie (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx sérotypu 10X&xxxx;^1,2&xxxx;2,2 μx

xxxxxxxxxxxx bakterie (xxxxxxxxxx) Streptococcus pneumoniae xxxxxxxx 11X&xxxx;^1,2&xxxx;2,2 μx

xxxxxxxxxxxx xxxxxxxx (pneumokoka) Streptococcus xxxxxxxxxx sérotypu 12F ^1,2 2,2 μx

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

polysacharid bakterie (xxxxxxxxxx) Xxxxxxxxxxxxx pneumoniae xxxxxxxx 15B ^1,2 2,2 μx

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

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

xxxxxxxxxxxx bakterie (xxxxxxxxxx) Streptococcus xxxxxxxxxx xxxxxxxx 19F ^1,2 2,2 μg

polysacharid xxxxxxxx (xxxxxxxxxx) Streptococcus xxxxxxxxxx xxxxxxxx 22X&xxxx;^1,2&xxxx;2,2 μx

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

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

¹ Xxxxxxxxxx s nosným xxxxxxxxx XXX₁₉₇&xxxx;(xxxxxxxxx 51 μx na xxxxx)

² Xxxxxxxxxx xx xxxxxxxxxxx xxxxxxx (0,125 xx xxxxxxx xx dávku)

1i) očkovací xxxxx proti záškrtu, xxxxxxxx xxxxx (acelulární xxxxx), tetanu, xxxxxx xxxxxxxx xxxxx (xxxxxxxxxxxx xxxxx):

Xxxxx dávka (0,5 xx) obsahuje:

Diphtheriae xxxxxxxxxx¹&xxxx;- xx méně xxx 2 xxxxxxxxxxx jednotky (XX) (2,5 Lf)

Tetani xxxxxxxxxx¹&xxxx;- ne xxxx xxx 20 xxxxxxxxxxxxx xxxxxxxx (IU) (5 Xx)

Xxxxxxxxxxx xxxxxxxxx antigena:

Pertussis xxxxxxxxxx^1-&xxxx;8 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxx xxxxxxxxxxxx¹&xxxx;- 8 xxxxxxxxxx

Xxxxxxxxx¹&xxxx;2,5 xxxxxxxxxx

Xxxxx xxxxxxxxxxxxxxx inactivatum:

ty xxx 1 (kmen Xxxxxxx)²&xxxx;- 40 D xxxxxxxx antigenu

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

typus 3 (xxxx Saukett)² - 32 X xxxxxxxx xxxxxxxx

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

² pomnoženo xx XXXX xxxxxxx

XXXX

1xx)&xxxx;xxxxxxxx látka xxxxx xxxxxxx, xxxxxxxx xxxxx (acelulární forma), xxxxxx, xxxxxx xxxxxxxx xxxxx (xxxxxxxxxxxx xxxxx):

Xxxxx xxxxx (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx xxxxxxxxxx xxxxxxxxx 2 XX* (2,5 Xx)

Xxxxxx anatoxinum xxxxxxxxx 20 XX* (5 Xx)

Xxxxxxxxx xxxxxxxx:

Xxxxxxxxx anatoxinum 2,5 mikrogramů

Pertussis haemagglutininum xxxxxxxxxxxx 5 mikrogramů

Pertactinum 3 mikrogramy

Fimbriae, xxxx 2 xx 3 5 mikrogramů

Virus xxxxxxxxxxxxxxx (xxxxxxxxxxx)**

xxxxx 1 40 X jednotek antigenu

ty xxx 2 8 X xxxxxxxx antigenu

typus 3 32 D xxxxxxxx xxxxxxxx

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

*&xxxx;Xxxx xxxxxx hranice xxxxxxxxx xxxxxxxxxxxxx (p = 0,95) aktivity xxxxxx xxxxx xxxxx xxxxxxxxx x Xxxxxxxxx xxxxxxxx.

**&xxxx;Xxxxxxxxxxx xx Xxxx xxxxxxx.

1x)&xxxx;xxxxxxxx látka xxxxx xxxxxxxxxxx (XXX xxxxxxx)

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

Xxxxx xxxxx (0,5 xx) xxxxxxx xxxxxxxx:

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

¹ xxxxxxxxxx na XX04X xxxxxxxxxx: - 3-X-xxxxxx-4'-xxxxxxxxxxxx-xxxxx X (XXX)²&xxxx;50 xxxxxxxxxx

² xxxxxxxxxxx na xxxxxxxxxxx xxxxxxx (xxxxxx 0,5 xxxxxxxxx Al³⁺)

³ xxxxxxxx xx kultuře xxxxxxxxxxxx xxxxx (Saccharomyces xxxxxxxxxx) xxxxxxxxxxxxx XXX xxxxxxxxxxx.

2.&xxxx;Xxxxxxxxx xxxxxxx xxxxxxxxxx xxxxx xxx zvláštní xxxxxxxx

2x)&xxxx;xxxxxxxx xxxxx xxxxx virové xxxxxxxxxx B xx xxxxxxx pro dospělé:

Jedna xxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx X - 20 xxxxxxxxxx

2x)&xxxx;xxxxxxxx látka xxxxx xxxxxxxxx

2x)&xxxx;xxxxxxxx xxxxx xxxxx virové hepatitidě X xx xxxxxxx xxx xxxxxxx:

Xxxxx xxxxx xxxxxxxx:

Xxxxxxxxx X virus xxxxxxxxxxx

2x)&xxxx;xxxxxxxx látka proti xxxxxxxxxx, xxxxxxxxxx x xxxxxxxxx:

Xxxxx dávka obsahuje:

Morbillorum 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 RA 27/3) xxx. 10^3,0 infekční xxxxx xxx xxxxxxxx kulturu₅₀³

¹ pomnoženo xx buňkách xxxxxxxx xxxxxx

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

³&xxxx;50% xxxxxxxx xxxxx xxxxxxx xxxxxxx

XXXX

2xx)&xxxx;xxxxxxxx xxxxx xxxxx xxxxxxxxxx, příušnicím a xxxxxxxxx

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

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

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

Xxxxx xxxxxxxx²&xxxx;xxxxx xxxxxxxxxx (xxxx Xxxxxx RA 27/3) xx xxxx xxx 1x10³&xxxx;XXXX₅₀*

*&xxxx;50% xxxxxxxx xxxxx xxxxxxx xxxxxxx

¹&xxxx;xxxxxxxx xx xxxxxxx kuřecích xxxxxx.

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

3.&xxxx;Xxxxxxxxx xxxxxxx xxxxxxxxxx xxxxx xxx mimořádná xxxxxxxx

3x)&xxxx;xxxxxxxx xxxxx xxxxx xxxxxx xxxxxxxxxx X xx xxxxxxx xxx dospělé:

Virus xxxxxxxxx A xxxxxxxxxxx

3x)&xxxx;xxxxxxxx xxxxx proti virové xxxxxxxxxx A xx xxxxxxx pro xxxx:

Xxxxx xxxxxxxxx X inactivatum

3c) očkovací xxxxx xxxxx xxxxxxxxxx, xxxxxxxxxx x zarděnkám:

Jedna xxxxx xxxxxxxx:

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

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

Xxxxxxxx virus 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 xxxxxxxx xxxxxxxxxxx xxxxxxx (XXX-5)

³&xxxx;50% xxxxxxxx xxxxx xxxxxxx kultury

NEBO

3ca) očkovací xxxxx xxxxx xxxxxxxxxx, xxxxxxxxxx x xxxxxxxxx

Xx xxxxxxxxxx xxxxxxxx jedna 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 méně xxx 12,5x10³ CCID₅₀*

Virus xxxxxxxx²&xxxx;xxxxx xxxxxxxxxx (xxxx Xxxxxx XX 27/3) ne xxxx xxx 1x1 10³&xxxx;XXXX₅₀*

*&xxxx;50% xxxxxxxx xxxxx xxxxxxx xxxxxxx

¹&xxxx;xxxxxxxx xx xxxxxxx kuřecích xxxxxx.

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

Xxxxxxx:

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

Informace

Právní předpis č. 420/2023 Xx. xxxxx xxxxxxxxx xxxx 29.12.2023.

Ke xxx xxxxxxxx xxxxxx xxxxxxx xxxxx xxxxx xx doplňován.

Znění xxxxxxxxxxxx xxxxxxxx xxxxx xxxxxx xxxxxxxx xxxxxxxx v xxxxxxxx xxxx aktualizováno, xxxxx xx xxxx xxxxxx xxxxxxxxx změna xxxxx uvedeného xxxxxxxx xxxxxxxx.