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 očkovacích xxxxx xxx xxxxxxxxxx, xxxxxxxx a xxxxxxxxx xxxxxxxx xxx xxx 2024
&xxxx;

Xxxxxxxxxxxx zdravotnictví xxxxx §80 xxxx. 1 xxxx. x) xxxxxx x. 258/2000 Xx., x xxxxxxx veřejného xxxxxx a o xxxxx xxxxxxxxx souvisejících xxxxxx, xx xxxxx xxxxxxxxxx xxxxxxxx, xxxxxxx xx xxxxxxx doporučení Xxxxxxx xxxxxxxxxx xxxxxx xxxxxxxxx xxxxxxx xxxxxxxxxx xxxxx xxx pravidelná, xxxxxxxx x xxxxxxxxx xxxxxxxx pro rok 2024:

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

1x)&xxxx;xxxxxxxxxxx očkovací xxxxx xxxxx xxxxxxx, xxxxxxxx xxxxx (xxxxxxxxxx xxxxx), xxxxxx, xxxxxx přenosné xxxxx (inaktivovaná xxxxx), xxxxxx xxxxxxxxxx X, xxxxxxx xxxxxxxxx Xxxxxxxxxxx xxxxxxxxxx typ x (XXxXXxxXXXXXX)

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

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

Xxxxxx xxxxxxxxxx¹&xxxx;xx xxxx než 40 xxxxxxxxxxxxx xxxxxxxx (IU)

Antigeny Xxxxxxxxxx xxxxxxxxx:

Xxxxxxxxx anatoxinum (XX)¹&xxxx;25 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxxxx xxxxxxxxxxxx (FHA)¹ 25 xxxxxxxxxx

Xxxxxxxxxxx (XXX)¹&xxxx;8 mikrogramů

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

Xxxxx xxxxxxxxxxxxxxx inactivatum (XXX)

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

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

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

Xxxxxxxxxxx xxxxxxxxxx xxxxx b xxxxxxxxxxxxxxx

(Xxxxxxxxxxxxxxxxxxx xxxxxxxx) 10 xxxxxxxxxx

xxxx. xxx xxxxxx. xxxxxxxx xxxx xxxxx xxxxxxx xxxxxxxxx 25 mikrogramů

¹ adsorbováno xx hydroxid xxxxxxx, xxxxxxxxxxx (Al(OH)₃) 0,5 xxxxxxxxx Al³⁺

² vyrobeno rekombinantní XXX xxxxxxxxxxx xx xxxxxxx xxxxxxxxxxxx xxxxx (Xxxxxxxxxxxxx xxxxxxxxxx)

³&xxxx;xxxxxxxxxxx xx xxxxxxxxxxx xxxxxxx (XxXX₄) 0,32 miligramů Al³⁺

⁴ pomnoženo xx XXXX xxxxxxx

XXXX

1xx)&xxxx;xxxxxxxxxxx xxxxxxxx xxxxx xxxxx xxxxxxx, xxxxxxxx xxxxx (xxxxxxxxxx xxxxx), xxxxxx, xxxxxx xxxxxxxx obrně (xxxxxxxxxxxx xxxxx), xxxxxx xxxxxxxxxx B, nákazám xxxxxxxxx Xxxxxxxxxxx xxxxxxxxxx xxx b (DTaPHibVHBIPV)

Jedna xxxxx¹&xxxx;(0,5 ml) xxxxxxxx:

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

Tetani xxxxxxxxxx xx xxxx xxx 40 xxxxxxxxxxxxx jednotek (XX)²

Xxxxxxxx Bordetelly xxxxxxxxx

Xxxxxxxxx xxxxxxxxxx 25 xxxxxxxxxx

Xxxxxxxxxxxxxx xxxxxxxxxxxx 25 xxxxxxxxxx

Xxxxx Xxxxxxxxxxxxxxx (inaktivovaný)³

typus 1 (Xxxxxxx) 40 D xxxxxxxx xxxxxxxx⁴

xx xxx 2 (XXX-1) 8 X xxxxxxxx xxxxxxxx⁴

xxxxx 3 (Xxxxxxx) 32 X jednotek antigenu⁴

Antigenum xxxxxxxxx hepatitidis X⁵&xxxx;10 xxxxxxxxxx

Xxxxxxxxxxxxxxxxxxx xxxxxxxx xxxxxxxxxx xxxxxxxxxx X 12 xxxxxxxxxx

(Xxxxxxxxxxxxxxxxxxx phosphas)

conjugata cum xxxxxx xxxxxxxxxx 22-36 xxxxxxxxxx

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

²&xxxx;xxxx xxxxxx xxx spolehlivosti (p = 0,95)

³&xxxx;xxxxxxxxx xx XXXX buňkách

⁴ nebo xxxxxxxxxxxx xxxxxxxx xxxxxxxx stanovené xxxxxxx xxxxxxxxxxxxxx metodou

⁵ vyrobeno xxxxxxxxxxxxx XXX technologií x kvasinkových xxxxxxx Xxxxxxxxx xxxxxxxxxx

XXXX

1xx)&xxxx;Xxxxxxx proti xxxxxxx, xxxxxx, dávivému xxxxx (xxxxxxxxxx xxxxxxxxxx), xxxxxxxxxx B (rDNA), xxxxxx přenosné xxxxx (xxxxxxxxxxxx) x xxxxxxxxxxx xxxxxxx proti Haemophilus xxxx x (xxxxxxxxxxx)

Xxxxx xxxxx (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx xxxxxxxxxx¹&xxxx;xx xxxx xxx 20 XX

Xxxxxx xxxxxxxxxx¹&xxxx;xx xxxx než 40 IU

Antigena Xxxxxxxxxxx xxxxxxxx¹

Xxxxxxxxx xxxxxxxxxx (PT) 20 mikrogramů

Haemagglutinium filamentosum (XXX) 20 xxxxxxxxxx

Xxxxxxxxxxx (XXX) 3 xxxxxxxxxx

Xxxxxxxx xxxx 2 xx 3 (XXX) 5 xxxxxxxxxx

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

Xxxxx xxxxxxxxxxxxxxx (xxxxxxxxxxx)⁴

Xxxxx 1 (Xxxxxxx) 40 X xxxxxxxx xxxxxxxx⁵

Xxxxx 2 (XXX-1) 8 X xxxxxxxx xxxxxxxx⁵

Xxxxx 3 (Xxxxxxx) 32 D xxxxxxxx xxxxxxxx⁵

Xxxxxxxxxxxxxx Xxxxxxxxxx xxxxxxxxxx xxxxx x

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

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

²&xxxx;xxxxxxxxxxx xx xxxxxxxxxxx xxxxxxxx xxxxxxx xxxxxx (0,15 xx Xx³⁺)

³&xxxx;xxxxxxxx rekombinantní XXX technologií x xxxxxxxxxxxx xxxxxxx Xxxxxxxxxxxxx xxxxxxxxxx

⁴&xxxx;xxxxxxxxx xx Xxxx xxxxxxx

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

1x)&xxxx;xxxxxxxx látka xxxxx xxxxxxx, xxxxxxxx xxxxx (xxxxxxxxxx forma), xxxxxx (XXxX)

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

Xxxxxxxxxxx xxxxxxxxxx* ≥ 30 XX

Xxxxxx anatoxinum* ≥ 40 XX

Xxxxxxxxx xxxxxxxxxx* (XX) 25 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxxxxx* (XXX) 25 xxxxxxxxxx

Xxxxxxxxxxx* (69kD) 8 xxxxxxxxxx

*&xxxx;xxxxxxxxxxx na xxxxxxxx xxxxxxx xxxxxx: 0,5 xxxxxxxxx

XXXX

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

Xxxxx xxxxx (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx anatoxinum - Xxxxxxxxx 2 IU* (2 Xx)

Xxxxxx xxxxxxxxxx - Xxxxxxxxx 20 XX* (5 Xx)

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

XXXX

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

Xxxxx xxxxx (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx anatoxinum¹ ne méně xxx 2 mezinárodní xxxxxxxx (XX) (2,5 Xx)

Xxxxxx anatoxinum¹ ne xxxx xxx 20 mezinárodních xxxxxxxx (XX) (5 Xx)

Xxxxxxxxxxx pertussis xxxxxxxx:

Xxxxxxxxx xxxxxxxxxx¹&xxxx;8 mikrogramu

Pertussis xxxxxxxxxxxxxx xxxxxxxxxxxx¹&xxxx;8 mikrogramu

Pertussis xxxxxxxxx xxxxxxxx proteinům¹ 2,5 mikrogramu

¹ adsorbováno xx xxxxxxxxxxx xxxxxxxx xxxxxxx (Xx(XX)₃) 0,3 xxxxxxxxx Xx^3+&xxxx;x xxxxxxxxxxx xxxxxxx (XXXX₄) 0,2 xxxxxxxxx Al³⁺

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

Xxxxx dávka xxxxxxxxxxxxx xxxxxxx obsahuje:

Polysaccharidum Hib xxxxxxxxxxx (10 mikrogramu) xxx Xxxxxxxxx xxxxxxxx (xxxxxxxxx 25 xxxxxxxxxx).

1x)&xxxx;xxxxxxxx xxxxx proti xxxxxx:

Xxxxx xxxxx obsahuje:

Tetani xxxxxxxxxx - min. 40 xxxxxxxxxxxxx xxxxxxxx

1x)&xxxx;xxxxxxxx xxxxx xxxxx xxxxxx xxxxxxxxxx X v xxxxxx xxxxxxx:

Xxxxx xxxxx obsahuje:

Antigenum xxxxxxxxx xxxxxxxxxxx B - 10 xxxxxxxxxx

1x)&xxxx;xxxxxxxx xxxxx xxxxx virové xxxxxxxxxx X v xxxxxxx xxxxxxx

Xxxxx dávka xxxxxxxx:

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx X - 20 xxxxxxxxxx

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

Xxxxx xxxxx xxxxxxxx:

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

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

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

¹&xxxx;xxxxxxxxx xx xxxxxxx kuřecích xxxxxx

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

³&xxxx;50% xxxxxxxx dávka tkáňové xxxxxxx

XXXX

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

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

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

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

Xxxxx xxxxxxxx²&xxxx;xxxxx attenuatum (xxxx Xxxxxx XX 27/3) xx xxxx než 1x10³&xxxx;XXXX₅₀*

*&xxxx;50% infekční xxxxx xxxxxxx xxxxxxx

¹&xxxx;xxxxxxxx xx xxxxxxx kuřecích embryí.

² vyrobeno xx xxxxxxxx xxxxxxxxxxx xxxxxxxx XX-38 xxxxxxxxxxxxx.

1x)&xxxx;xxxxxxxx xxxxx proti dětské xxxxxxxx obrně v xxxxxxxxxxxx xxxxx:

Xxxxx dávka xxxxxxxx:

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

Virus xxxxxxxxxxxxx xxxxxxxxxxx xxxxx 2 (XXX-1) .......... 8 xxxxxxxxxxx X xxxxxxxx*

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

*&xxxx;xxxx xxxxxxxx xxxxxxxxxxxxxx xxxxxxxx stanovené xxxxxx xxxxxx imunochemické xxxxxx.

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

1xxx)&xxxx;xxxxxxxxxxx xxxxxxxx xxxxx obsahuje:

Streptococci pneumoniae xxxxxxxxxxxxxxx sérotypus 1^l 2,2 μx

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 3¹ 2,2 μx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 4¹&xxxx;2,2 μg

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

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 6A¹ 2,2 μx

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

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 7F¹ 2,2 μx

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

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

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 18C¹ 2,2 μx

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

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

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 23F¹ 2,2 μx

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

X

1xxx)&xxxx;xxxxx pneumokokovým xxxxxxxx

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

XXXX

1xxx)&xxxx;xxxxxxxxxxx xxxxxxxx xxxxx xxxxx xxxxxxxxxxxxx xxxxxxxx

Xxxxx xxxxx (0,5 ml) xxxxxxxx:

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

xxxxxxxxxxxx bakterie (xxxxxxxxxx) Streptococcus pneumoniae xxxxxxxx 3 ^1,2 2,2 μx

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

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

xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx pneumoniae xxxxxxxx 6A ^1,2 2,2 μg

polysacharid xxxxxxxx (xxxxxxxxxx) Streptococcus xxxxxxxxxx sérotypu 6X&xxxx;^1,2&xxxx;4,4 μx

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

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

xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx sérotypu 9V ^1,2 2,2 μx

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

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

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

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

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

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

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

xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx pneumoniae xxxxxxxx 19F ^1,2 2,2 μg

polysacharid xxxxxxxx (pneumokoka) Streptococcus xxxxxxxxxx xxxxxxxx 22F ^1,2 2,2 μx

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

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

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

² Xxxxxxxxxx xx fosforečnan xxxxxxx (0,125 xx xxxxxxx na xxxxx)

1x)&xxxx;xxxxxxxx xxxxx xxxxx xxxxxxx, xxxxxxxx xxxxx (xxxxxxxxxx xxxxx), xxxxxx, xxxxxx xxxxxxxx xxxxx (xxxxxxxxxxxx xxxxx):

Xxxxx xxxxx (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx xxxxxxxxxx¹&xxxx;- xx xxxx než 2 mezinárodní xxxxxxxx (XX) (2,5 Xx)

Xxxxxx xxxxxxxxxx¹&xxxx;- ne xxxx xxx 20 mezinárodních xxxxxxxx (IU) (5 Xx)

Xxxxxxxxxxx pertussis xxxxxxxx:

Xxxxxxxxx xxxxxxxxxx^1-&xxxx;8 xxxxxxxxxx

Xxxxxxxxx haemagglutinum xxxxxxxxxxxx¹&xxxx;- 8 xxxxxxxxxx

Xxxxxxxxx¹&xxxx;2,5 xxxxxxxxxx

Xxxxx xxxxxxxxxxxxxxx xxxxxxxxxxx:

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

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

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

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

² xxxxxxxxx xx XXXX xxxxxxx

XXXX

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

Jedna xxxxx (0,5 xx) xxxxxxxx:

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

Xxxxxx xxxxxxxxxx xxxxxxxxx 20 IU* (5 Xx)

Xxxxxxxxx antigeny:

Pertussis xxxxxxxxxx 2,5 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxxxx xxxxxxxxxxxx 5 xxxxxxxxxx

Xxxxxxxxxxx 3 mikrogramy

Fimbriae, xxxx 2 xx 3 5 xxxxxxxxxx

Xxxxx poliomyelitidis (xxxxxxxxxxx)**

xxxxx 1 40 X xxxxxxxx xxxxxxxx

xx xxx 2 8 X xxxxxxxx antigenu

typus 3 32 D xxxxxxxx antigenu

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

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

**&xxxx;Xxxxxxxxxxx na Xxxx xxxxxxx.

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

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

Jedna xxxxx (0,5 ml) xxxxxxx xxxxxxxx:

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

¹ xxxxxxxxxx na AS04C xxxxxxxxxx: - 3-X-xxxxxx-4'-xxxxxxxxxxxx-xxxxx X (XXX)²&xxxx;50 xxxxxxxxxx

² xxxxxxxxxxx na xxxxxxxxxxx xxxxxxx (celkem 0,5 xxxxxxxxx Xx³⁺)

³ vyrobeno xx xxxxxxx kvasinkových xxxxx (Saccharomyces cerevisiae) xxxxxxxxxxxxx DNA xxxxxxxxxxx.

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

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

Jedna xxxxx xxxxxxxx:

Xxxxxxxxx tegiminis xxxxxxxxxxx B - 20 xxxxxxxxxx

2x)&xxxx;xxxxxxxx xxxxx xxxxx vzteklině

2c) očkovací xxxxx xxxxx xxxxxx xxxxxxxxxx X ve formuli xxx dospělé:

Jedna xxxxx xxxxxxxx:

Xxxxxxxxx X xxxxx xxxxxxxxxxx

2x)&xxxx;xxxxxxxx xxxxx xxxxx xxxxxxxxxx, příušnicím x xxxxxxxxx:

Xxxxx xxxxx xxxxxxxx:

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

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

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

¹ pomnoženo xx xxxxxxx kuřecích xxxxxx

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

³&xxxx;50% xxxxxxxx xxxxx xxxxxxx xxxxxxx

XXXX

2xx)&xxxx;xxxxxxxx látka xxxxx xxxxxxxxxx, xxxxxxxxxx x xxxxxxxxx

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

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

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

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

*&xxxx;50% infekční xxxxx xxxxxxx xxxxxxx

¹&xxxx;xxxxxxxx na xxxxxxx kuřecích xxxxxx.

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

3. Antigenní xxxxxxx xxxxxxxxxx látek xxx xxxxxxxxx xxxxxxxx

3x)&xxxx;xxxxxxxx xxxxx xxxxx xxxxxx xxxxxxxxxx X ve xxxxxxx pro dospělé:

Virus xxxxxxxxx A inactivatum

3b) očkovací xxxxx xxxxx xxxxxx xxxxxxxxxx X xx xxxxxxx pro xxxx:

Xxxxx xxxxxxxxx X xxxxxxxxxxx

3x)&xxxx;xxxxxxxx xxxxx xxxxx spalničkám, xxxxxxxxxx x xxxxxxxxx:

Xxxxx xxxxx obsahuje:

Morbillorum virus xxxxxxxxxx¹&xxxx;(Xxxxxxx) xxx. 10^3,0 infekční xxxxx pro 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 na xxxxxxx kuřecích xxxxxx

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

³ 50% infekční xxxxx tkáňové kultury

NEBO

3ca) očkovací xxxxx xxxxx xxxxxxxxxx, xxxxxxxxxx x xxxxxxxxx

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

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

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

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

*&xxxx;50% xxxxxxxx xxxxx xxxxxxx xxxxxxx

¹&xxxx;xxxxxxxx xx xxxxxxx xxxxxxxx xxxxxx.

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

Xxxxxxx:

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

Xxxxxxxxx

Xxxxxx xxxxxxx x. 420/2023 Xx. xxxxx xxxxxxxxx dnem 29.12.2023.

Xx xxx xxxxxxxx právní xxxxxxx xxxxx xxxxx xx xxxxxxxxx.

Xxxxx xxxxxxxxxxxx xxxxxxxx norem jiných xxxxxxxx xxxxxxxx x xxxxxxxx xxxx xxxxxxxxxxxxx, xxxxx xx xxxx xxxxxx derogační xxxxx xxxxx xxxxxxxxx xxxxxxxx xxxxxxxx.