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. prosince 2023

o xxxxxxxxxx xxxxxxx xxxxxxxxxx xxxxx pro pravidelná, xxxxxxxx a xxxxxxxxx xxxxxxxx pro rok 2024
&xxxx;

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

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

1x)&xxxx;xxxxxxxxxxx xxxxxxxx xxxxx xxxxx xxxxxxx, dávivému xxxxx (xxxxxxxxxx xxxxx), xxxxxx, xxxxxx xxxxxxxx xxxxx (inaktivovaná xxxxx), xxxxxx hepatitidě B, xxxxxxx xxxxxxxxx Haemophilus xxxxxxxxxx xxx x (XXxXXxxXXXXXX)

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

Xxxxxxxxxxx xxxxxxxxxx¹&xxxx;xx xxxx xxx 30 mezinárodních xxxxxxxx (IU)

Tetani xxxxxxxxxx¹&xxxx;xx xxxx xxx 40 xxxxxxxxxxxxx xxxxxxxx (XX)

Xxxxxxxx Xxxxxxxxxx xxxxxxxxx:

Xxxxxxxxx xxxxxxxxxx (XX)¹&xxxx;25 mikrogramů

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

Xxxxxxxxxxx (XXX)¹&xxxx;8 mikrogramů

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

Xxxxx xxxxxxxxxxxxxxx xxxxxxxxxxx (XXX)

xx xxx 1 (xxxx Xxxxxxx)^4&xxxx;40 X xxxxxxxx xxxxxxxx

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

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

Haemophilus xxxxxxxxxx xxxxx b xxxxxxxxxxxxxxx

(Xxxxxxxxxxxxxxxxxxx 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 Al³⁺

² vyrobeno xxxxxxxxxxxxx XXX xxxxxxxxxxx xx xxxxxxx xxxxxxxxxxxx xxxxx (Xxxxxxxxxxxxx cerevisiae)

³ adsorbováno xx xxxxxxxxxxx xxxxxxx (XxXX₄) 0,32 xxxxxxxxx Al³⁺

⁴ pomnoženo xx XXXX xxxxxxx

XXXX

1xx)&xxxx;xxxxxxxxxxx xxxxxxxx xxxxx proti xxxxxxx, xxxxxxxx xxxxx (xxxxxxxxxx forma), tetanu, xxxxxx xxxxxxxx obrně (xxxxxxxxxxxx forma), xxxxxx xxxxxxxxxx X, xxxxxxx xxxxxxxxx Haemophilus xxxxxxxxxx xxx x (XXxXXxxXXXXXX)

Xxxxx xxxxx¹&xxxx;(0,5 xx) xxxxxxxx:

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

Xxxxxx anatoxinum xx méně než 40 xxxxxxxxxxxxx xxxxxxxx (XX)²

Xxxxxxxx Xxxxxxxxxx pertussis

Pertussis xxxxxxxxxx 25 xxxxxxxxxx

Xxxxxxxxxxxxxx xxxxxxxxxxxx 25 mikrogramů

Virus Xxxxxxxxxxxxxxx (xxxxxxxxxxxx)³

xxxxx 1 (Xxxxxxx) 40 X xxxxxxxx xxxxxxxx⁴

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

xxxxx 3 (Saukett) 32 X xxxxxxxx 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 Xx³⁺)

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

³&xxxx;xxxxxxxxx xx XXXX xxxxxxx

⁴&xxxx;xxxx xxxxxxxxxxxx xxxxxxxx xxxxxxxx xxxxxxxxx xxxxxxx xxxxxxxxxxxxxx metodou

⁵ vyrobeno xxxxxxxxxxxxx DNA xxxxxxxxxxx x kvasinkových xxxxxxx Xxxxxxxxx polymorpha

NEBO

1ab) Vakcína xxxxx xxxxxxx, xxxxxx, xxxxxxxx xxxxx (xxxxxxxxxx komponenta), xxxxxxxxxx B (rDNA), xxxxxx xxxxxxxx xxxxx (xxxxxxxxxxxx) x xxxxxxxxxxx xxxxxxx xxxxx Haemophilus xxxx x (xxxxxxxxxxx)

Xxxxx xxxxx (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx xxxxxxxxxx¹&xxxx;xx xxxx xxx 20 IU

Tetani xxxxxxxxxx¹&xxxx;xx xxxx xxx 40 XX

Xxxxxxxx Bordetellae xxxxxxxx¹

Xxxxxxxxx xxxxxxxxxx (XX) 20 xxxxxxxxxx

Xxxxxxxxxxxxxxx xxxxxxxxxxxx (XXX) 20 mikrogramů

Pertactinum (XXX) 3 xxxxxxxxxx

Xxxxxxxx xxxx 2 xx 3 (FIM) 5 xxxxxxxxxx

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

Xxxxx poliomyelitidis (xxxxxxxxxxx)⁴

Xxxxx 1 (Mahoney) 40 D xxxxxxxx xxxxxxxx⁵

Xxxxx 2 (XXX-1) 8 D xxxxxxxx xxxxxxxx⁵

Xxxxx 3 (Xxxxxxx) 32 X xxxxxxxx xxxxxxxx⁵

Xxxxxxxxxxxxxx Xxxxxxxxxx influenzae xxxxx b

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

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

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

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

⁴&xxxx;xxxxxxxxx na Vero xxxxxxx

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

1x)&xxxx;xxxxxxxx xxxxx xxxxx xxxxxxx, xxxxxxxx xxxxx (acelulární xxxxx), xxxxxx (XXxX)

Xxxxx dávka (0,5 ml) xxxxxxxx xxxx xxxxxx 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 xx xxxxxxxx hlinitý xxxxxx: 0,5 xxxxxxxxx

XXXX

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

Xxxxx xxxxx (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx xxxxxxxxxx - Xxxxxxxxx 2 XX* (2 Xx)

Xxxxxx xxxxxxxxxx - Minimálně 20 XX* (5 Lf)

Pertusové xxxxxxxx

Xxxxxxxxx xxxxxxxxxx - 2,5 mikrogramu

Haemagglutinum xxxxxxxxxxxx - 5 xxxxxxxxxx

Xxxxxxxxxxx - 3 xxxxxxxxxx

Xxxxxxxx, xxxx 2 et 3 - 5 xxxxxxxxxx

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

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

XXXX

1xx)&xxxx;Xxxxxxxx látka xxxxx xxxxxxx, xxxxxx x xxxxxxxx xxxxx (xxxxxxxxxx xxxxxxxxxx) se 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 antigena:

Pertussis xxxxxxxxxx¹&xxxx;8 xxxxxxxxxx

Xxxxxxxxx haemagglutinum xxxxxxxxxxxx¹&xxxx;8 mikrogramu

Pertussis xxxxxxxxx xxxxxxxx xxxxxxxxx¹&xxxx;2,5 xxxxxxxxxx

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

1c) očkovací látka xxxxx xxxxxxx xxxxxxxxx Xxxxxxxxxxx influenzae xxx x:

Xxxxx dávka lyofilizované xxxxxxx xxxxxxxx:

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

1d) očkovací xxxxx proti xxxxxx:

Xxxxx xxxxx xxxxxxxx:

Xxxxxx xxxxxxxxxx - xxx. 40 xxxxxxxxxxxxx xxxxxxxx

1x)&xxxx;xxxxxxxx xxxxx xxxxx virové hepatitidě X x dětské xxxxxxx:

Xxxxx dávka xxxxxxxx:

Xxxxxxxxx xxxxxxxxx hepatitidis X - 10 xxxxxxxxxx

1x)&xxxx;xxxxxxxx xxxxx xxxxx xxxxxx xxxxxxxxxx B x xxxxxxx formuli

Jedna xxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx X - 20 xxxxxxxxxx

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

Xxxxx xxxxx obsahuje:

Morbillorum xxxxx attenuatum¹ (Schwarz) min. 10^3,0&xxxx;xxxxxxxx xxxxx xxx xxxxxxxx kulturu₅₀³

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

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

¹&xxxx;xxxxxxxxx xx xxxxxxx kuřecích xxxxxx

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

³ 50% xxxxxxxx xxxxx xxxxxxx xxxxxxx

XXXX

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

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

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

Xxxxx xxxxxxxxxxx¹&xxxx;xxxxx attenuatum (xxxx Jeryl Xxxx™, xxxxxxx B) ne xxxx xxx 12,5x10³&xxxx;XXXX₅₀*

Xxxxx xxxxxxxx²&xxxx;xxxxx xxxxxxxxxx (xxxx Xxxxxx RA 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 diploidních xxxxxxxx XX-38 xxxxxxxxxxxxx.

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

Xxxxx xxxxx xxxxxxxx:

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

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

Xxxxx xxxxxxxxxxxxx inactivatum xxxxx 3 (Xxxxxxx) ........ 32 antigenních X xxxxxxxx*

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

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

1cha) konjugovaná xxxxxxxx xxxxx xxxxxxxx:

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 1^x&xxxx;2,2 μx

Xxxxxxxxxxxx pneumoniae polysaecharidum xxxxxxxxx 3¹ 2,2 μx

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

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

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 6A¹ 2,2 μx

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

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx sérotypus 7F¹ 2,2 μx

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 9V¹ 2,2 μx

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

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 18X¹&xxxx;2,2 μx

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

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

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

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

X

1xxx)&xxxx;xxxxx pneumokokovým xxxxxxxx

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

XXXX

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

Xxxxx xxxxx (0,5 xx) xxxxxxxx:

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

polysacharid xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 3 ^1,2 2,2 μx

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

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

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

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

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

polysacharid xxxxxxxx (xxxxxxxxxx) Streptococcus xxxxxxxxxx xxxxxxxx 8&xxxx;^1,2&xxxx;2,2 μg

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

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

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

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

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

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

xxxxxxxxxxxx bakterie (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 19F ^1,2 2,2 μx

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

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

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

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

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

1x)&xxxx;xxxxxxxx xxxxx xxxxx xxxxxxx, xxxxxxxx kašli (xxxxxxxxxx xxxxx), tetanu, dětské xxxxxxxx xxxxx (xxxxxxxxxxxx xxxxx):

Xxxxx dávka (0,5 xx) xxxxxxxx:

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

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

Xxxxxxxxxxx xxxxxxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxxx^1-&xxxx;8 mikrogramů

Pertussis xxxxxxxxxxxxxx xxxxxxxxxxxx¹&xxxx;- 8 xxxxxxxxxx

Xxxxxxxxx¹&xxxx;2,5 xxxxxxxxxx

Xxxxx xxxxxxxxxxxxxxx xxxxxxxxxxx:

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

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

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

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

² xxxxxxxxx xx XXXX xxxxxxx

XXXX

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

Xxxxx xxxxx (0,5 ml) xxxxxxxx:

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

Xxxxxx xxxxxxxxxx minimálně 20 IU* (5 Xx)

Xxxxxxxxx xxxxxxxx:

Xxxxxxxxx anatoxinum 2,5 xxxxxxxxxx

Xxxxxxxxx haemagglutininum xxxxxxxxxxxx 5 xxxxxxxxxx

Xxxxxxxxxxx 3 xxxxxxxxxx

Xxxxxxxx, typi 2 xx 3 5 xxxxxxxxxx

Xxxxx poliomyelitidis (xxxxxxxxxxx)**

xxxxx 1 40 X jednotek antigenu

ty xxx 2 8 X jednotek antigenu

typus 3 32 X xxxxxxxx xxxxxxxx

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

*&xxxx;Xxxx xxxxxx xxxxxxx xxxxxxxxx spolehlivosti (p = 0,95) xxxxxxxx xxxxxx xxxxx xxxxx xxxxxxxxx v Xxxxxxxxx xxxxxxxx.

**&xxxx;Xxxxxxxxxxx xx Xxxx xxxxxxx.

1x)&xxxx;xxxxxxxx xxxxx xxxxx xxxxxxxxxxx (BCG vakcína)

1k) očkovací xxxxx xxxxx virové xxxxxxxxxx B pro xxxxx xxxxxxxx do xxxxxxxxxxxx xxxxxxxx:

Xxxxx xxxxx (0,5 xx) vakcíny xxxxxxxx:

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

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

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

³ xxxxxxxx xx xxxxxxx xxxxxxxxxxxx xxxxx (Saccharomyces xxxxxxxxxx) xxxxxxxxxxxxx XXX technologií.

2. Antigenní xxxxxxx očkovacích xxxxx xxx zvláštní xxxxxxxx

2x)&xxxx;xxxxxxxx xxxxx xxxxx xxxxxx xxxxxxxxxx B xx xxxxxxx xxx xxxxxxx:

Xxxxx xxxxx xxxxxxxx:

Xxxxxxxxx tegiminis xxxxxxxxxxx B - 20 mikrogramů

2b) očkovací látka xxxxx xxxxxxxxx

2x)&xxxx;xxxxxxxx látka xxxxx xxxxxx hepatitidě X ve formuli xxx xxxxxxx:

Xxxxx dávka xxxxxxxx:

Xxxxxxxxx X xxxxx xxxxxxxxxxx

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

Xxxxx xxxxx xxxxxxxx:

Xxxxxxxxxxx xxxxx attenuatum¹ (Schwarz) 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 xxxxxxxxxx^2&xxxx;(Xxxxxx XX 27/3) xxx. 10^3,0&xxxx;xxxxxxxx dávka xxx buněčnou xxxxxxx₅₀³

¹&xxxx;xxxxxxxxx xx xxxxxxx xxxxxxxx xxxxxx

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

³ 50% xxxxxxxx dávka xxxxxxx xxxxxxx

XXXX

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

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

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

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

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

*&xxxx;50% infekční xxxxx xxxxxxx xxxxxxx

¹&xxxx;xxxxxxxx xx xxxxxxx kuřecích embryí.

² vyrobeno xx lidských diploidních xxxxxxxx WI-38 xxxxxxxxxxxxx.

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

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

Virus xxxxxxxxx X xxxxxxxxxxx

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

Virus xxxxxxxxx X xxxxxxxxxxx

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

Jedna xxxxx xxxxxxxx:

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

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

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

¹&xxxx;xxxxxxxxx xx xxxxxxx xxxxxxxx xxxxxx

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

³ 50% xxxxxxxx xxxxx tkáňové xxxxxxx

XXXX

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

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

Xxxxx xxxxxxxxxxx¹&xxxx;xxxxx attenuatum (xxxx Xxxxxx’ Xxxxxxxxx) xx xxxx xxx 1x10³ CCID₅₀*

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

Xxxxx xxxxxxxx²&xxxx;xxxxx xxxxxxxxxx (kmen Xxxxxx 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 WI-38 xxxxxxxxxxxxx.
&xxxx;

Xxxxxxx:

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

Informace

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

Xx xxx uzávěrky xxxxxx xxxxxxx nebyl xxxxx xx xxxxxxxxx.

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