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

x xxxxxxxxxx xxxxxxx očkovacích xxxxx xxx xxxxxxxxxx, xxxxxxxx x mimořádná xxxxxxxx pro xxx 2024
&xxxx;

Xxxxxxxxxxxx xxxxxxxxxxxxx podle §80 xxxx. 1 xxxx. x) xxxxxx x. 258/2000 Xx., x ochraně xxxxxxxxx xxxxxx x x xxxxx xxxxxxxxx xxxxxxxxxxxxx xxxxxx, xx znění xxxxxxxxxx xxxxxxxx, xxxxxxx xx xxxxxxx xxxxxxxxxx Xxxxxxx imunizační xxxxxx xxxxxxxxx složení očkovacích xxxxx xxx xxxxxxxxxx, xxxxxxxx x xxxxxxxxx xxxxxxxx xxx xxx 2024:

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

1x)&xxxx;xxxxxxxxxxx očkovací látka xxxxx záškrtu, xxxxxxxx xxxxx (acelulární forma), xxxxxx, xxxxxx přenosné xxxxx (xxxxxxxxxxxx xxxxx), xxxxxx hepatitidě X, xxxxxxx xxxxxxxxx Xxxxxxxxxxx xxxxxxxxxx xxx b (XXxXXxxXXXXXX)

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

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

Xxxxxx anatoxinum¹ ne xxxx xxx 40 xxxxxxxxxxxxx xxxxxxxx (IU)

Antigeny Xxxxxxxxxx xxxxxxxxx:

Xxxxxxxxx anatoxinum (XX)¹&xxxx;25 mikrogramů

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

Xxxxxxxxxxx (XXX)¹&xxxx;8 mikrogramů

Antigenum xxxxxxxxx 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 antigenu

Haemophilus xxxxxxxxxx xxxxx b xxxxxxxxxxxxxxx

(Xxxxxxxxxxxxxxxxxxx xxxxxxxx) 10 xxxxxxxxxx

xxxx. xxx xxxxxx. tetanico xxxx nosný protein xxxxxxxxx 25 mikrogramů

¹ adsorbováno xx xxxxxxxx xxxxxxx, xxxxxxxxxxx (Xx(XX)₃) 0,5 xxxxxxxxx Xx³⁺

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

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

⁴&xxxx;xxxxxxxxx xx XXXX buňkách

NEBO

1aa) kombinovaná xxxxxxxx xxxxx proti xxxxxxx, xxxxxxxx kašli (xxxxxxxxxx forma), xxxxxx, xxxxxx xxxxxxxx xxxxx (xxxxxxxxxxxx xxxxx), virové xxxxxxxxxx X, nákazám xxxxxxxxx Xxxxxxxxxxx influenzae xxx x (XXxXXxxXXXXXX)

Xxxxx xxxxx¹&xxxx;(0,5 xx) xxxxxxxx:

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

Xxxxxx anatoxinum xx xxxx xxx 40 xxxxxxxxxxxxx jednotek (XX)²

Xxxxxxxx Xxxxxxxxxx xxxxxxxxx

Xxxxxxxxx xxxxxxxxxx 25 xxxxxxxxxx

Xxxxxxxxxxxxxx xxxxxxxxxxxx 25 mikrogramů

Virus Xxxxxxxxxxxxxxx (inaktivovaný)³

typus 1 (Xxxxxxx) 40 X xxxxxxxx xxxxxxxx⁴

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

xxxxx 3 (Saukett) 32 X jednotek xxxxxxxx⁴

Xxxxxxxxx xxxxxxxxx hepatitidis X⁵&xxxx;10 xxxxxxxxxx

Xxxxxxxxxxxxxxxxxxx xxxxxxxx xxxxxxxxxx xxxxxxxxxx X 12 xxxxxxxxxx

(Xxxxxxxxxxxxxxxxxxx xxxxxxxx)

xxxxxxxxx cum xxxxxx anatoxinum 22-36 xxxxxxxxxx

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

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

³ pomnoženo xx XXXX xxxxxxx

⁴&xxxx;xxxx xxxxxxxxxxxx xxxxxxxx xxxxxxxx stanovené xxxxxxx imunochemickou xxxxxxx

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

XXXX

1xx)&xxxx;Xxxxxxx xxxxx xxxxxxx, xxxxxx, xxxxxxxx xxxxx (xxxxxxxxxx komponenta), xxxxxxxxxx X (xXXX), xxxxxx xxxxxxxx xxxxx (xxxxxxxxxxxx) x xxxxxxxxxxx xxxxxxx xxxxx Xxxxxxxxxxx xxxx x (xxxxxxxxxxx)

Xxxxx xxxxx (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx xxxxxxxxxx¹&xxxx;xx méně xxx 20 IU

Tetani xxxxxxxxxx¹&xxxx;xx méně xxx 40 IU

Antigena Bordetellae xxxxxxxx¹

Xxxxxxxxx xxxxxxxxxx (XX) 20 mikrogramů

Haemagglutinium xxxxxxxxxxxx (XXX) 20 xxxxxxxxxx

Xxxxxxxxxxx (XXX) 3 mikrogramy

Fimbriae xxxx 2 xx 3 (XXX) 5 xxxxxxxxxx

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

Virus xxxxxxxxxxxxxxx (xxxxxxxxxxx)⁴

Xxxxx 1 (Xxxxxxx) 40 D xxxxxxxx xxxxxxxx⁵

Xxxxx 2 (MEF-1) 8 X xxxxxxxx xxxxxxxx⁵

Xxxxx 3 (Xxxxxxx) 32 X xxxxxxxx xxxxxxxx⁵

Xxxxxxxxxxxxxx Xxxxxxxxxx influenzae xxxxx b

(Polyribosylribitoli phosphas) 3 xxxxxxxxxx xxxxxxxxxx xxx proteinům xxxxxxxxxxxx xxxxx x²&xxxx;50 xxxxxxxxxx

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

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

³&xxxx;xxxxxxxx rekombinantní XXX xxxxxxxxxxx v xxxxxxxxxxxx xxxxxxx Saccharomyces xxxxxxxxxx

⁴&xxxx;xxxxxxxxx na Xxxx xxxxxxx

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

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

Xxxxx dávka (0,5 xx) xxxxxxxx xxxx xxxxxx látky:

Diphtheriae xxxxxxxxxx* ≥ 30 XX

Xxxxxx xxxxxxxxxx* ≥ 40 IU

Pertussis xxxxxxxxxx* (XX) 25 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxxx filamentosum* (XXX) 25 xxxxxxxxxx

Xxxxxxxxxxx* (69xX) 8 xxxxxxxxxx

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

XXXX

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

Xxxxx xxxxx (0,5 ml) xxxxxxxx:

Xxxxxxxxxxx anatoxinum - Xxxxxxxxx 2 IU* (2 Lf)

Tetani xxxxxxxxxx - Minimálně 20 XX* (5 Xx)

Xxxxxxxxx xxxxxxxx

Xxxxxxxxx xxxxxxxxxx - 2,5 mikrogramu

Haemagglutinum xxxxxxxxxxxx - 5 mikrogramu

Pertactinum - 3 xxxxxxxxxx

Xxxxxxxx, xxxx 2 xx 3 - 5 xxxxxxxxxx

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

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

XXXX

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

Xxxxx xxxxx (0,5 xx) xxxxxxxx:

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

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

Xxxxxxxxxxx xxxxxxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxxx¹&xxxx;8 xxxxxxxxxx

Xxxxxxxxx haemagglutinum xxxxxxxxxxxx¹&xxxx;8 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxx xxxxxxxx proteinům¹ 2,5 xxxxxxxxxx

¹&xxxx;xxxxxxxxxxx xx xxxxxxxxxxx xxxxxxxx xxxxxxx (Xx(XX)₃) 0,3 xxxxxxxxx Xx^3+&xxxx;x xxxxxxxxxxx xxxxxxx (AIPO₄) 0,2 xxxxxxxxx Al³⁺

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

Xxxxx xxxxx xxxxxxxxxxxxx xxxxxxx xxxxxxxx:

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

1x)&xxxx;xxxxxxxx xxxxx xxxxx xxxxxx:

Xxxxx xxxxx obsahuje:

Tetani xxxxxxxxxx - xxx. 40 xxxxxxxxxxxxx xxxxxxxx

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

Xxxxx dávka xxxxxxxx:

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx X - 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 látka xxxxx xxxxxxxxxx, příušnicím x xxxxxxxxx:

Xxxxx xxxxx xxxxxxxx:

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

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

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

¹&xxxx;xxxxxxxxx xx buňkách xxxxxxxx xxxxxx

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

³&xxxx;50% xxxxxxxx dávka xxxxxxx xxxxxxx

XXXX

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

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

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

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

Xxxxx xxxxxxxx²&xxxx;xxxxx xxxxxxxxxx (kmen 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.

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

Jedna xxxxx xxxxxxxx:

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

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

Xxxxx xxxxxxxxxxxxx xxxxxxxxxxx xxxxx 3 (Saukett) ........ 32 antigenních X xxxxxxxx*

*&xxxx;xxxx xxxxxxxx ekvivalentních xxxxxxxx xxxxxxxxx xxxxxx xxxxxx xxxxxxxxxxxxx metody.

1ch) očkovací xxxxx proti pneumokokovým xxxxxxxx xxxxxxxxx x xxxxxxxxxx xxxxxxxx:

1xxx)&xxxx;xxxxxxxxxxx xxxxxxxx xxxxx xxxxxxxx:

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

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

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

Streptococci xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 5¹ 2,2 μx

Xxxxxxxxxxxx xxxxxxxxxx polysaecharidum xxxxxxxxx 6A¹ 2,2 μg

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

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 7F¹ 2,2 μx

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

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

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

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

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

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

¹ Xxxxxxxxxx x 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, 6X, 7F, 8, 9N, 9X, 10X, 11X, 12F, 14, 15X, 17X, 18X, 19F, 19A, 20, 22F, 23F, 33X.

XXXX

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

Jedna xxxxx (0,5 xx) xxxxxxxx:

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

polysacharid bakterie (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 3 ^1,2 2,2 μg

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

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

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

xxxxxxxxxxxx xxxxxxxx (pneumokoka) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 6B ^1,2 4,4 μx

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

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

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

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

xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Streptococcus xxxxxxxxxx xxxxxxxx 11A ^1,2 2,2 μg

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

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

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

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

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

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

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

1x)&xxxx;xxxxxxxx xxxxx proti xxxxxxx, xxxxxxxx kašli (acelulární xxxxx), xxxxxx, xxxxxx xxxxxxxx xxxxx (inaktivovaná xxxxx):

Xxxxx xxxxx (0,5 xx) obsahuje:

Diphtheriae xxxxxxxxxx¹&xxxx;- xx xxxx xxx 2 mezinárodní xxxxxxxx (XX) (2,5 Xx)

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

Xxxxxxxxxxx xxxxxxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxxx^1-&xxxx;8 mikrogramů

Pertussis xxxxxxxxxxxxxx xxxxxxxxxxxx¹&xxxx;- 8 mikrogramů

Pertaktin¹ 2,5 xxxxxxxxxx

Xxxxx xxxxxxxxxxxxxxx inactivatum:

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

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

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

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

² xxxxxxxxx xx XXXX buňkách

NEBO

1ia) očkovací xxxxx xxxxx záškrtu, dávivému xxxxx (xxxxxxxxxx xxxxx), xxxxxx, xxxxxx xxxxxxxx xxxxx (xxxxxxxxxxxx forma):

Jedna xxxxx (0,5 xx) xxxxxxxx:

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

Xxxxxx xxxxxxxxxx xxxxxxxxx 20 XX* (5 Xx)

Xxxxxxxxx antigeny:

Pertussis xxxxxxxxxx 2,5 xxxxxxxxxx

Xxxxxxxxx haemagglutininum xxxxxxxxxxxx 5 xxxxxxxxxx

Xxxxxxxxxxx 3 xxxxxxxxxx

Xxxxxxxx, typi 2 et 3 5 xxxxxxxxxx

Xxxxx xxxxxxxxxxxxxxx (xxxxxxxxxxx)**

xxxxx 1 40 X jednotek xxxxxxxx

xx xxx 2 8 X xxxxxxxx antigenu

typus 3 32 D xxxxxxxx antigenu

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

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

**&xxxx;Xxxxxxxxxxx na Xxxx xxxxxxx.

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

1x)&xxxx;xxxxxxxx xxxxx xxxxx xxxxxx xxxxxxxxxx X xxx xxxxx xxxxxxxx do xxxxxxxxxxxx xxxxxxxx:

Xxxxx xxxxx (0,5 ml) vakcíny xxxxxxxx:

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

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

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

³ xxxxxxxx xx xxxxxxx kvasinkových xxxxx (Xxxxxxxxxxxxx xxxxxxxxxx) xxxxxxxxxxxxx XXX technologií.

2. Antigenní xxxxxxx očkovacích látek xxx zvláštní očkování

2a) očkovací xxxxx xxxxx virové xxxxxxxxxx X xx xxxxxxx xxx xxxxxxx:

Xxxxx xxxxx xxxxxxxx:

Xxxxxxxxx tegiminis xxxxxxxxxxx X - 20 xxxxxxxxxx

2x)&xxxx;xxxxxxxx látka xxxxx xxxxxxxxx

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

Xxxxx xxxxx xxxxxxxx:

Xxxxxxxxx X virus xxxxxxxxxxx

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

Xxxxx xxxxx xxxxxxxx:

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

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

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

¹&xxxx;xxxxxxxxx xx buňkách xxxxxxxx xxxxxx

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

³&xxxx;50% xxxxxxxx dávka tkáňové xxxxxxx

XXXX

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

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

Xxxxx morbillorum¹ vivum xxxxxxxxxx (xxxx Xxxxxx’ Xxxxxxxxx) xx xxxx xxx 1x10³&xxxx;XXXX₅₀*

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

Xxxxx xxxxxxxx²&xxxx;xxxxx attenuatum (xxxx 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 xxxxxxxx xxxxxxxxxxx xxxxxxxx XX-38 fibroblastech.

3. Antigenní xxxxxxx xxxxxxxxxx látek xxx xxxxxxxxx očkování

3a) očkovací xxxxx xxxxx xxxxxx xxxxxxxxxx X ve xxxxxxx pro xxxxxxx:

Xxxxx xxxxxxxxx A xxxxxxxxxxx

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

Xxxxx xxxxxxxxx A inactivatum

3c) očkovací xxxxx proti xxxxxxxxxx, xxxxxxxxxx x xxxxxxxxx:

Xxxxx xxxxx obsahuje:

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

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

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

¹&xxxx;xxxxxxxxx na xxxxxxx xxxxxxxx embryí

² pomnoženo xx lidských xxxxxxxxxxx xxxxxxx (XXX-5)

³&xxxx;50% xxxxxxxx xxxxx tkáňové xxxxxxx

XXXX

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

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

Virus xxxxxxxxxxx¹&xxxx;xxxxx xxxxxxxxxx (kmen Xxxxxx’ Edmonston) ne xxxx xxx 1x10³ CCID₅₀*

Virus xxxxxxxxxxx¹&xxxx;xxxxx xxxxxxxxxx (xxxx Xxxxx Xxxx™, hladina X) ne méně xxx 12,5x10³ CCID₅₀*

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

*&xxxx;50% infekční dávka xxxxxxx kultury

¹ vyrobeno xx xxxxxxx kuřecích embryí.

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

Xxxxxxx:

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

Xxxxxxxxx

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

Xx xxx uzávěrky právní xxxxxxx nebyl xxxxx xx doplňován.

Znění xxxxxxxxxxxx xxxxxxxx xxxxx jiných xxxxxxxx xxxxxxxx v xxxxxxxx xxxx aktualizováno, xxxxx se jich xxxxxx xxxxxxxxx změna xxxxx uvedeného právního xxxxxxxx.