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 x xxxxxxxxx xxxxxxxx xxx xxx 2024
&xxxx;

Xxxxxxxxxxxx xxxxxxxxxxxxx xxxxx §80 xxxx. 1 xxxx. x) xxxxxx x. 258/2000 Xx., x xxxxxxx veřejného xxxxxx x x xxxxx některých xxxxxxxxxxxxx xxxxxx, xx xxxxx xxxxxxxxxx xxxxxxxx, xxxxxxx xx xxxxxxx doporučení Xxxxxxx xxxxxxxxxx xxxxxx xxxxxxxxx xxxxxxx xxxxxxxxxx xxxxx xxx pravidelná, xxxxxxxx x mimořádná xxxxxxxx xxx xxx 2024:

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

1x)&xxxx;xxxxxxxxxxx očkovací látka xxxxx xxxxxxx, dávivému xxxxx (xxxxxxxxxx xxxxx), xxxxxx, xxxxxx xxxxxxxx xxxxx (xxxxxxxxxxxx xxxxx), xxxxxx xxxxxxxxxx B, xxxxxxx xxxxxxxxx Xxxxxxxxxxx xxxxxxxxxx typ x (XXxXXxxXXXXXX)

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

Xxxxxxxxxxx anatoxinum¹ ne xxxx xxx 30 mezinárodních xxxxxxxx (XX)

Xxxxxx xxxxxxxxxx¹&xxxx;xx xxxx xxx 40 xxxxxxxxxxxxx jednotek (IU)

Antigeny Xxxxxxxxxx xxxxxxxxx:

Xxxxxxxxx xxxxxxxxxx (XX)¹&xxxx;25 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxxxx xxxxxxxxxxxx (FHA)¹ 25 xxxxxxxxxx

Xxxxxxxxxxx (XXX)¹&xxxx;8 mikrogramů

Antigenum tegiminis xxxxxxxxxxx X (HBs)^2,3 10 xxxxxxxxxx

Xxxxx xxxxxxxxxxxxxxx inactivatum (XXX)

xx xxx 1 (xxxx Mahoney)⁴ 40 X xxxxxxxx xxxxxxxx

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

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

Xxxxxxxxxxx influenzae xxxxx b xxxxxxxxxxxxxxx

(Xxxxxxxxxxxxxxxxxxx xxxxxxxx) 10 mikrogramů

conj. xxx xxxxxx. tetanico xxxx nosný xxxxxxx 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 xxxxx (Xxxxxxxxxxxxx xxxxxxxxxx)

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

⁴&xxxx;xxxxxxxxx xx VERO xxxxxxx

XXXX

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

Xxxxx xxxxx¹&xxxx;(0,5 xx) xxxxxxxx:

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

Xxxxxx xxxxxxxxxx xx xxxx xxx 40 mezinárodních jednotek (XX)²

Xxxxxxxx Xxxxxxxxxx xxxxxxxxx

Xxxxxxxxx xxxxxxxxxx 25 xxxxxxxxxx

Xxxxxxxxxxxxxx xxxxxxxxxxxx 25 xxxxxxxxxx

Xxxxx Xxxxxxxxxxxxxxx (xxxxxxxxxxxx)³

xxxxx 1 (Xxxxxxx) 40 X xxxxxxxx xxxxxxxx⁴

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

xxxxx 3 (Saukett) 32 X jednotek antigenu⁴

Antigenum xxxxxxxxx hepatitidis X⁵&xxxx;10 xxxxxxxxxx

Xxxxxxxxxxxxxxxxxxx xxxxxxxx xxxxxxxxxx xxxxxxxxxx X 12 xxxxxxxxxx

(Xxxxxxxxxxxxxxxxxxx xxxxxxxx)

xxxxxxxxx xxx xxxxxx anatoxinum 22-36 xxxxxxxxxx

¹&xxxx;xxxxxxxxxxx xx hydratovaný xxxxxxxx hlinitý (0,6 xx Al³⁺)

² jako spodní xxx xxxxxxxxxxxxx (p = 0,95)

³&xxxx;xxxxxxxxx xx XXXX buňkách

⁴ nebo xxxxxxxxxxxx xxxxxxxx xxxxxxxx xxxxxxxxx xxxxxxx xxxxxxxxxxxxxx xxxxxxx

⁵&xxxx;xxxxxxxx xxxxxxxxxxxxx DNA xxxxxxxxxxx x xxxxxxxxxxxx xxxxxxx Xxxxxxxxx polymorpha

NEBO

1ab) Vakcína proti xxxxxxx, xxxxxx, xxxxxxxx xxxxx (acelulární xxxxxxxxxx), xxxxxxxxxx X (xXXX), xxxxxx xxxxxxxx obrně (xxxxxxxxxxxx) a konjugovaná xxxxxxx xxxxx Xxxxxxxxxxx xxxx x (adsorbovaná)

Jedna xxxxx (0,5 ml) xxxxxxxx:

Xxxxxxxxxxx xxxxxxxxxx¹&xxxx;xx méně xxx 20 XX

Xxxxxx xxxxxxxxxx¹&xxxx;xx xxxx xxx 40 XX

Xxxxxxxx Xxxxxxxxxxx xxxxxxxx¹

Xxxxxxxxx xxxxxxxxxx (PT) 20 xxxxxxxxxx

Xxxxxxxxxxxxxxx xxxxxxxxxxxx (XXX) 20 mikrogramů

Pertactinum (XXX) 3 xxxxxxxxxx

Xxxxxxxx xxxx 2 xx 3 (FIM) 5 xxxxxxxxxx

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

Xxxxx poliomyelitidis (xxxxxxxxxxx)⁴

Xxxxx 1 (Xxxxxxx) 40 X xxxxxxxx xxxxxxxx⁵

Xxxxx 2 (XXX-1) 8 X xxxxxxxx xxxxxxxx⁵

Xxxxx 3 (Saukett) 32 X xxxxxxxx xxxxxxxx⁵

Xxxxxxxxxxxxxx Haemophili xxxxxxxxxx xxxxx x

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

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

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

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

⁴&xxxx;xxxxxxxxx na Xxxx xxxxxxx

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

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

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

Xxxxxxxxxxx xxxxxxxxxx* ≥ 30 XX

Xxxxxx xxxxxxxxxx* ≥ 40 XX

Xxxxxxxxx anatoxinum* (XX) 25 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxxxxx* (XXX) 25 mikrogramů

Pertactinum* (69xX) 8 mikrogramů

* adsorbováno na xxxxxxxx xxxxxxx xxxxxx: 0,5 xxxxxxxxx

XXXX

1xx)&xxxx;Xxxxxxxx xxxxx xxxxx xxxxxxx, xxxxxx x dávivému xxxxx (xxxxxxxxxx) xx xxxxxxxx xxxxxxx antigenů (Tdap)

Jedna xxxxx (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx xxxxxxxxxx - Xxxxxxxxx 2 IU* (2 Xx)

Xxxxxx anatoxinum - Xxxxxxxxx 20 XX* (5 Xx)

Xxxxxxxxx xxxxxxxx

Xxxxxxxxx xxxxxxxxxx - 2,5 mikrogramu

Haemagglutinum 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 xxxxxx xxxxxxx xxxxxxxxx spolehlivosti (p = 0,95) xxxxxxxx xxxxxx xxxxx testu xxxxxxxxx v Xxxxxxxxx xxxxxxxx.

XXXX

1xx)&xxxx;Xxxxxxxx látka xxxxx xxxxxxx, tetanu a xxxxxxxx xxxxx (xxxxxxxxxx xxxxxxxxxx) xx xxxxxxxx xxxxxxx xxxxxxxx (Xxxx)

Xxxxx xxxxx (0,5 ml) xxxxxxxx:

Xxxxxxxxxxx xxxxxxxxxx¹&xxxx;xx méně xxx 2 xxxxxxxxxxx xxxxxxxx (XX) (2,5 Xx)

Xxxxxx xxxxxxxxxx¹&xxxx;xx xxxx xxx 20 xxxxxxxxxxxxx xxxxxxxx (IU) (5 Xx)

Xxxxxxxxxxx xxxxxxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxxx¹&xxxx;8 xxxxxxxxxx

Xxxxxxxxx haemagglutinum xxxxxxxxxxxx¹&xxxx;8 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxx xxxxxxxx xxxxxxxxx¹&xxxx;2,5 xxxxxxxxxx

¹&xxxx;xxxxxxxxxxx xx xxxxxxxxxxx hydroxid xxxxxxx (Al(OH)₃) 0,3 xxxxxxxxx Xx^3+&xxxx;x xxxxxxxxxxx xxxxxxx (XXXX₄) 0,2 xxxxxxxxx Al³⁺

1c) očkovací xxxxx xxxxx nákazám xxxxxxxxx Xxxxxxxxxxx xxxxxxxxxx typ x:

Xxxxx dávka lyofilizované xxxxxxx xxxxxxxx:

Xxxxxxxxxxxxxxx Xxx xxxxxxxxxxx (10 xxxxxxxxxx) xxx Anatoxino xxxxxxxx (xxxxxxxxx 25 xxxxxxxxxx).

1x)&xxxx;xxxxxxxx xxxxx proti xxxxxx:

Xxxxx xxxxx xxxxxxxx:

Xxxxxx xxxxxxxxxx - xxx. 40 xxxxxxxxxxxxx jednotek

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

Xxxxx xxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx B - 10 mikrogramu

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

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

Rubeolae virus xxxxxxxxxx²&xxxx;(Xxxxxx RA 27/3) xxx. 10^3,0 infekční dávka xxx buněčnou kulturu₅₀³

¹ pomnoženo xx xxxxxxx xxxxxxxx xxxxxx

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

³ 50% xxxxxxxx xxxxx tkáňové xxxxxxx

XXXX

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

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

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

Xxxxx parotitidis¹ vivum attenuatum (xxxx Jeryl Lynn™, xxxxxxx X) xx xxxx než 12,5x10³ CCID₅₀*

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

*&xxxx;50% xxxxxxxx dávka xxxxxxx xxxxxxx

¹&xxxx;xxxxxxxx xx xxxxxxx xxxxxxxx embryí.

² vyrobeno xx xxxxxxxx xxxxxxxxxxx xxxxxxxx XX-38 xxxxxxxxxxxxx.

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

Xxxxx xxxxx xxxxxxxx:

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

Virus poliomyelitis xxxxxxxxxxx typus 2 (XXX-1) .......... 8 xxxxxxxxxxx X jednotek*

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

*&xxxx;xxxx množství xxxxxxxxxxxxxx xxxxxxxx xxxxxxxxx xxxxxx xxxxxx xxxxxxxxxxxxx metody.

1ch) očkovací xxxxx xxxxx xxxxxxxxxxxxx xxxxxxxx xxxxxxxxx x xxxxxxxxxx schématu:

1cha) konjugovaná očkovací xxxxx xxxxxxxx:

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 1^l 2,2 μx

Xxxxxxxxxxxx xxxxxxxxxx polysaecharidum xxxxxxxxx 3¹&xxxx;2,2 μx

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

Streptococci xxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 5¹ 2,2 μx

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

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

Streptococci xxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 7F¹ 2,2 μx

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

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

Streptococci xxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 18X¹&xxxx;2,2 μx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 19A¹ 2,2 μx

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

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

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

X

1xxx)&xxxx;xxxxx xxxxxxxxxxxxx xxxxxxxx

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

XXXX

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

Xxxxx xxxxx (0,5 ml) xxxxxxxx:

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

polysacharid xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 3&xxxx;^1,2&xxxx;2,2 μg

polysacharid xxxxxxxx (pneumokoka) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 4&xxxx;^1,2&xxxx;2,2 μx

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

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

polysacharid xxxxxxxx (xxxxxxxxxx) Streptococcus xxxxxxxxxx xxxxxxxx 6B ^1,2 4,4 μx

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

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

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

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

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

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

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

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

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

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

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

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

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

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

¹ Xxxxxxxxxx x xxxxxx xxxxxxxxx XXX₁₉₇&xxxx;(xxxxxxxxx 51 μx xx xxxxx)

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

1i) očkovací xxxxx xxxxx záškrtu, xxxxxxxx xxxxx (xxxxxxxxxx xxxxx), xxxxxx, dětské xxxxxxxx obrně (xxxxxxxxxxxx xxxxx):

Xxxxx xxxxx (0,5 xx) xxxxxxxx:

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

Xxxxxx xxxxxxxxxx¹&xxxx;- xx xxxx xxx 20 xxxxxxxxxxxxx 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 poliomyelitidis inactivatum:

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

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

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

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

² pomnoženo na XXXX xxxxxxx

XXXX

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

Xxxxx xxxxx (0,5 xx) xxxxxxxx:

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

Xxxxxx xxxxxxxxxx xxxxxxxxx 20 XX* (5 Xx)

Xxxxxxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxxx 2,5 xxxxxxxxxx

Xxxxxxxxx haemagglutininum xxxxxxxxxxxx 5 mikrogramů

Pertactinum 3 mikrogramy

Fimbriae, xxxx 2 xx 3 5 mikrogramů

Virus xxxxxxxxxxxxxxx (xxxxxxxxxxx)**

xxxxx 1 40 X xxxxxxxx antigenu

ty xxx 2 8 X xxxxxxxx xxxxxxxx

xxxxx 3 32 D xxxxxxxx antigenu

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

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

**&xxxx;Xxxxxxxxxxx na Vero xxxxxxx.

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

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

Jedna xxxxx (0,5 ml) xxxxxxx xxxxxxxx:

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

¹ xxxxxxxxxx xx XX04X xxxxxxxxxx: - 3-O-deacyl-4'-monofosforyl-lipid X (XXX)²&xxxx;50 xxxxxxxxxx

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

³ vyrobeno xx xxxxxxx kvasinkových xxxxx (Xxxxxxxxxxxxx xxxxxxxxxx) xxxxxxxxxxxxx XXX xxxxxxxxxxx.

2.&xxxx;Xxxxxxxxx xxxxxxx xxxxxxxxxx látek xxx xxxxxxxx xxxxxxxx

2x)&xxxx;xxxxxxxx xxxxx xxxxx virové xxxxxxxxxx X ve xxxxxxx xxx dospělé:

Jedna xxxxx obsahuje:

Antigenum xxxxxxxxx xxxxxxxxxxx B - 20 xxxxxxxxxx

2x)&xxxx;xxxxxxxx látka xxxxx xxxxxxxxx

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

Xxxxx dávka xxxxxxxx:

Xxxxxxxxx X xxxxx xxxxxxxxxxx

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

Xxxxx dávka xxxxxxxx:

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

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

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

¹ pomnoženo xx buňkách kuřecích xxxxxx

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

³&xxxx;50% xxxxxxxx xxxxx xxxxxxx xxxxxxx

XXXX

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

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

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

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

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

*&xxxx;50% infekční dávka xxxxxxx xxxxxxx

¹&xxxx;xxxxxxxx na xxxxxxx xxxxxxxx embryí.

² vyrobeno xx xxxxxxxx xxxxxxxxxxx xxxxxxxx WI-38 xxxxxxxxxxxxx.

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

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

Xxxxx xxxxxxxxx X xxxxxxxxxxx

3x)&xxxx;xxxxxxxx xxxxx xxxxx virové xxxxxxxxxx A ve xxxxxxx xxx xxxx:

Xxxxx xxxxxxxxx X inactivatum

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

Jedna xxxxx obsahuje:

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

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

Xxxxxxxx virus attenuatum² (Wistar XX 27/3) min. 10^3,0&xxxx;xxxxxxxx xxxxx xxx xxxxxxxx xxxxxxx₅₀³

¹&xxxx;xxxxxxxxx na xxxxxxx xxxxxxxx xxxxxx

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

³ 50% infekční xxxxx tkáňové xxxxxxx

XXXX

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

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

Virus xxxxxxxxxxx¹&xxxx;xxxxx attenuatum (kmen Xxxxxx’ Xxxxxxxxx) xx xxxx než 1x10³ CCID₅₀*

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

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

*&xxxx;50% infekční xxxxx xxxxxxx xxxxxxx

¹&xxxx;xxxxxxxx na xxxxxxx xxxxxxxx xxxxxx.

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

Ministr:

prof. XXXx. Xxxxx, XXx, XXX, EBIR, v. x.

Xxxxxxxxx

Xxxxxx xxxxxxx č. 420/2023 Xx. nabyl xxxxxxxxx xxxx 29.12.2023.

Xx xxx uzávěrky xxxxxx xxxxxxx nebyl xxxxx xx xxxxxxxxx.

Xxxxx xxxxxxxxxxxx xxxxxxxx norem xxxxxx xxxxxxxx xxxxxxxx x xxxxxxxx xxxx xxxxxxxxxxxxx, xxxxx xx jich xxxxxx xxxxxxxxx xxxxx xxxxx uvedeného právního xxxxxxxx.