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

SDĚLENÍ

Ministerstva xxxxxxxxxxxxx

xx xxx 19. prosince 2023

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

Xxxxxxxxxxxx xxxxxxxxxxxxx xxxxx §80 xxxx. 1 xxxx. x) zákona x. 258/2000 Xx., x ochraně xxxxxxxxx xxxxxx x o xxxxx xxxxxxxxx xxxxxxxxxxxxx xxxxxx, xx znění xxxxxxxxxx xxxxxxxx, stanoví xx základě xxxxxxxxxx Xxxxxxx xxxxxxxxxx xxxxxx xxxxxxxxx xxxxxxx xxxxxxxxxx xxxxx pro xxxxxxxxxx, xxxxxxxx x xxxxxxxxx xxxxxxxx xxx xxx 2024:

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

1x)&xxxx;xxxxxxxxxxx xxxxxxxx látka xxxxx xxxxxxx, xxxxxxxx xxxxx (xxxxxxxxxx xxxxx), xxxxxx, xxxxxx xxxxxxxx xxxxx (xxxxxxxxxxxx xxxxx), xxxxxx xxxxxxxxxx X, xxxxxxx xxxxxxxxx Xxxxxxxxxxx xxxxxxxxxx xxx x (XXxXXxxXXXXXX)

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

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

Xxxxxx anatoxinum¹ ne xxxx než 40 xxxxxxxxxxxxx jednotek (XX)

Xxxxxxxx Xxxxxxxxxx pertussis:

Pertussis xxxxxxxxxx (XX)¹&xxxx;25 mikrogramů

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

Pertactinum (XXX)¹&xxxx;8 mikrogramů

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

Xxxxx poliomyelitidis xxxxxxxxxxx (XXX)

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

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

xxxxx 3 (xxxx Saukett)⁴ 32 X xxxxxxxx xxxxxxxx

Xxxxxxxxxxx influenzae xxxxx x xxxxxxxxxxxxxxx

(Xxxxxxxxxxxxxxxxxxx xxxxxxxx) 10 xxxxxxxxxx

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

¹&xxxx;xxxxxxxxxxx xx hydroxid xxxxxxx, xxxxxxxxxxx (Al(OH)₃) 0,5 xxxxxxxxx Xx³⁺

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

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

⁴ pomnoženo xx VERO xxxxxxx

XXXX

1xx)&xxxx;xxxxxxxxxxx xxxxxxxx látka proti xxxxxxx, xxxxxxxx kašli (xxxxxxxxxx xxxxx), tetanu, xxxxxx xxxxxxxx xxxxx (xxxxxxxxxxxx xxxxx), virové xxxxxxxxxx B, xxxxxxx xxxxxxxxx Haemophilus influenzae xxx b (XXxXXxxXXXXXX)

Xxxxx xxxxx¹&xxxx;(0,5 xx) obsahuje:

Diphtheriae xxxxxxxxxx xx méně xxx 20 mezinárodních xxxxxxxx (IU)²

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

Xxxxxxxx Xxxxxxxxxx xxxxxxxxx

Xxxxxxxxx xxxxxxxxxx 25 xxxxxxxxxx

Xxxxxxxxxxxxxx xxxxxxxxxxxx 25 xxxxxxxxxx

Xxxxx Xxxxxxxxxxxxxxx (xxxxxxxxxxxx)³

xxxxx 1 (Xxxxxxx) 40 X xxxxxxxx antigenu⁴

ty pus 2 (XXX-1) 8 X jednotek xxxxxxxx⁴

xxxxx 3 (Saukett) 32 X jednotek antigenu⁴

Antigenum xxxxxxxxx xxxxxxxxxxx X⁵&xxxx;10 xxxxxxxxxx

Xxxxxxxxxxxxxxxxxxx xxxxxxxx haemophili xxxxxxxxxx X 12 xxxxxxxxxx

(Xxxxxxxxxxxxxxxxxxx xxxxxxxx)

xxxxxxxxx xxx xxxxxx xxxxxxxxxx 22-36 xxxxxxxxxx

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

²&xxxx;xxxx spodní xxx spolehlivosti (x = 0,95)

³ pomnoženo xx XXXX xxxxxxx

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

⁵ vyrobeno xxxxxxxxxxxxx XXX xxxxxxxxxxx x kvasinkových xxxxxxx Xxxxxxxxx polymorpha

NEBO

1ab) Vakcína proti xxxxxxx, tetanu, dávivému xxxxx (xxxxxxxxxx xxxxxxxxxx), xxxxxxxxxx X (rDNA), xxxxxx xxxxxxxx obrně (xxxxxxxxxxxx) x xxxxxxxxxxx xxxxxxx xxxxx Xxxxxxxxxxx xxxx b (xxxxxxxxxxx)

Xxxxx xxxxx (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx xxxxxxxxxx¹&xxxx;xx xxxx xxx 20 XX

Xxxxxx xxxxxxxxxx¹&xxxx;xx xxxx než 40 XX

Xxxxxxxx Xxxxxxxxxxx xxxxxxxx¹

Xxxxxxxxx xxxxxxxxxx (XX) 20 xxxxxxxxxx

Xxxxxxxxxxxxxxx xxxxxxxxxxxx (XXX) 20 xxxxxxxxxx

Xxxxxxxxxxx (XXX) 3 xxxxxxxxxx

Xxxxxxxx xxxx 2 xx 3 (XXX) 5 xxxxxxxxxx

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

Xxxxx xxxxxxxxxxxxxxx (xxxxxxxxxxx)⁴

Xxxxx 1 (Xxxxxxx) 40 D xxxxxxxx xxxxxxxx⁵

Xxxxx 2 (MEF-1) 8 X xxxxxxxx xxxxxxxx⁵

Xxxxx 3 (Xxxxxxx) 32 X jednotek xxxxxxxx⁵

Xxxxxxxxxxxxxx Xxxxxxxxxx influenzae xxxxx x

(Xxxxxxxxxxxxxxxxxxx phosphas) 3 xxxxxxxxxx xxxxxxxxxx xxx proteinům meningococci xxxxx x²&xxxx;50 xxxxxxxxxx

¹&xxxx;xxxxxxxxxxx xx xxxxxxxxxxx hlinitý (0,17 mg 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 xx Vero xxxxxxx

⁵&xxxx;xxxx ekvivalentní xxxxxxxx xxxxxxxx xxxxxxxxx vhodnou xxxxxxxxxxxxxx xxxxxxx.

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

Jedna dávka (0,5 xx) xxxxxxxx xxxx xxxxxx xxxxx:

Xxxxxxxxxxx xxxxxxxxxx* ≥ 30 XX

Xxxxxx xxxxxxxxxx* ≥ 40 XX

Xxxxxxxxx xxxxxxxxxx* (XX) 25 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxxx filamentosum* (XXX) 25 xxxxxxxxxx

Xxxxxxxxxxx* (69xX) 8 xxxxxxxxxx

*&xxxx;xxxxxxxxxxx na xxxxxxxx xxxxxxx celkem: 0,5 miligramů

NEBO

1ba) Očkovací látka xxxxx xxxxxxx, xxxxxx x xxxxxxxx kašli (xxxxxxxxxx) se xxxxxxxx xxxxxxx xxxxxxxx (Xxxx)

Xxxxx xxxxx (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx anatoxinum - Xxxxxxxxx 2 XX* (2 Xx)

Xxxxxx xxxxxxxxxx - Xxxxxxxxx 20 XX* (5 Xx)

Xxxxxxxxx xxxxxxxx

Xxxxxxxxx xxxxxxxxxx - 2,5 xxxxxxxxxx

Xxxxxxxxxxxxxx xxxxxxxxxxxx - 5 xxxxxxxxxx

Xxxxxxxxxxx - 3 xxxxxxxxxx

Xxxxxxxx, xxxx 2 xx 3 - 5 xxxxxxxxxx

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

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

XXXX

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

Jedna xxxxx (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx xxxxxxxxxx¹&xxxx;xx xxxx xxx 2 mezinárodní xxxxxxxx (IU) (2,5 Xx)

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

Xxxxxxxxxxx xxxxxxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxxx¹&xxxx;8 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxx xxxxxxxxxxxx¹&xxxx;8 mikrogramu

Pertussis xxxxxxxxx xxxxxxxx proteinům¹ 2,5 mikrogramu

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

1c) očkovací látka xxxxx xxxxxxx vyvolaným Xxxxxxxxxxx xxxxxxxxxx typ x:

Xxxxx xxxxx xxxxxxxxxxxxx xxxxxxx xxxxxxxx:

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

1d) očkovací xxxxx xxxxx xxxxxx:

Xxxxx xxxxx xxxxxxxx:

Xxxxxx xxxxxxxxxx - min. 40 xxxxxxxxxxxxx jednotek

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

Xxxxx dávka xxxxxxxx:

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx X - 10 mikrogramu

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

Xxxxx xxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx X - 20 xxxxxxxxxx

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

Xxxxx xxxxx obsahuje:

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

Xxxxxxxxxxx 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 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 xxxxxxx xxxxxxx

XXXX

1xx)&xxxx;xxxxxxxx látka 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 Jeryl Xxxx™, xxxxxxx X) 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 xx xxxxxxx kuřecích xxxxxx.

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

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

Jedna xxxxx xxxxxxxx:

Xxxxx poliomyelitis inactivatum xxxxx 1 (Mahoney) ..... 40 antigenních X jednotek*

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

Virus xxxxxxxxxxxxx inactivatum typus 3 (Saukett) ........ 32 antigenních X xxxxxxxx*

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

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

1xxx)&xxxx;xxxxxxxxxxx očkovací xxxxx xxxxxxxx:

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

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 3¹ 2,2 μx

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

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

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 6A¹ 2,2 μg

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

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 7F¹ 2,2 μx

Xxxxxxxxxxxx xxxxxxxxxx polysaecharidum xxxxxxxxx 9V¹ 2,2 μg

Streptococci 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 polysaecharidum sérotypus 19X¹&xxxx;2,2 μg

Streptococci pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 23F¹ 2,2 μx

¹ Konjugován s xxxxxx xxxxxxxxx CRM197 x xxxxxxxxxx xx xxxxxxxxxxx hlinitý (0,125 xx hliníku).

A

1chb) proti xxxxxxxxxxxxx xxxxxxxx

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

XXXX

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

Xxxxx xxxxx (0,5 xx) xxxxxxxx:

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

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

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

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

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

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

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

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

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

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

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

xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx pneumoniae xxxxxxxx 15X&xxxx;^1,2&xxxx;2,2 μg

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

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

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

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

xxxxxxxxxxxx xxxxxxxx (pneumokoka) Xxxxxxxxxxxxx pneumoniae xxxxxxxx 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 dávku)

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

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

Xxxxx xxxxx (0,5 xx) xxxxxxxx:

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

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

Xxxxxxxxxxx pertussis antigena:

Pertussis xxxxxxxxxx^1-&xxxx;8 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxx xxxxxxxxxxxx¹&xxxx;- 8 xxxxxxxxxx

Xxxxxxxxx¹&xxxx;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 antigenu

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

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

² pomnoženo xx XXXX xxxxxxx

XXXX

1xx)&xxxx;xxxxxxxx xxxxx xxxxx záškrtu, dávivému xxxxx (xxxxxxxxxx xxxxx), xxxxxx, xxxxxx xxxxxxxx xxxxx (xxxxxxxxxxxx xxxxx):

Xxxxx xxxxx (0,5 ml) xxxxxxxx:

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

Xxxxxx anatoxinum xxxxxxxxx 20 IU* (5 Xx)

Xxxxxxxxx antigeny:

Pertussis xxxxxxxxxx 2,5 mikrogramů

Pertussis xxxxxxxxxxxxxxxx xxxxxxxxxxxx 5 mikrogramů

Pertactinum 3 xxxxxxxxxx

Xxxxxxxx, xxxx 2 xx 3 5 xxxxxxxxxx

Xxxxx xxxxxxxxxxxxxxx (xxxxxxxxxxx)**

xxxxx 1 40 X xxxxxxxx antigenu

ty xxx 2 8 X jednotek antigenu

typus 3 32 D xxxxxxxx antigenu

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

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

**&xxxx;Xxxxxxxxxxx xx Xxxx xxxxxxx.

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

1x)&xxxx;xxxxxxxx xxxxx proti xxxxxx xxxxxxxxxx X pro xxxxx xxxxxxxx xx xxxxxxxxxxxx programu:

Jedna dávka (0,5 ml) xxxxxxx xxxxxxxx:

Xxxxxxxxx tegiminis 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 xx xxxxxxxxxxx xxxxxxx (celkem 0,5 xxxxxxxxx Al³⁺)

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

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

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

Xxxxx xxxxx xxxxxxxx:

Xxxxxxxxx tegiminis xxxxxxxxxxx X - 20 xxxxxxxxxx

2x)&xxxx;xxxxxxxx xxxxx xxxxx xxxxxxxxx

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

Xxxxx xxxxx xxxxxxxx:

Xxxxxxxxx A xxxxx xxxxxxxxxxx

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

Xxxxx dávka obsahuje:

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

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

Xxxxxxxx virus xxxxxxxxxx^2&xxxx;(Xxxxxx RA 27/3) xxx. 10^3,0 infekční xxxxx xxx xxxxxxxx xxxxxxx₅₀³

¹&xxxx;xxxxxxxxx xx buňkách xxxxxxxx xxxxxx

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

³ 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 xxxxxxxxxx (xxxx Enders’ Xxxxxxxxx) xx xxxx než 1x10³&xxxx;XXXX₅₀*

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

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

*&xxxx;50% xxxxxxxx xxxxx xxxxxxx xxxxxxx

¹&xxxx;xxxxxxxx xx xxxxxxx kuřecích embryí.

² vyrobeno xx lidských xxxxxxxxxxx xxxxxxxx XX-38 fibroblastech.

3. Antigenní xxxxxxx xxxxxxxxxx látek xxx mimořádná xxxxxxxx

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

Xxxxx xxxxxxxxx X inactivatum

3b) očkovací xxxxx xxxxx xxxxxx xxxxxxxxxx A ve xxxxxxx xxx děti:

Virus xxxxxxxxx X xxxxxxxxxxx

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

Xxxxx xxxxx xxxxxxxx:

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

Xxxxxxxxxxx xxxxx attenuatum¹ (RIT 4385) xxx. 10^3,7&xxxx;xxxxxxxx xxxxx xxx xxxxxxxx xxxxxxx₅₀³

Xxxxxxxx xxxxx xxxxxxxxxx^2&xxxx;(Xxxxxx 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 diploidních xxxxxxx (XXX-5)

³&xxxx;50% xxxxxxxx xxxxx xxxxxxx kultury

NEBO

3ca) očkovací xxxxx xxxxx spalničkám, xxxxxxxxxx a xxxxxxxxx

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

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

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

Xxxxx xxxxxxxx²&xxxx;xxxxx xxxxxxxxxx (kmen Wistar XX 27/3) xx xxxx než 1x1 10³&xxxx;XXXX₅₀*

*&xxxx;50% xxxxxxxx xxxxx xxxxxxx xxxxxxx

¹&xxxx;xxxxxxxx xx xxxxxxx kuřecích xxxxxx.

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

Ministr:

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

Xxxxxxxxx

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

Ke xxx xxxxxxxx xxxxxx xxxxxxx nebyl xxxxx xx doplňován.

Znění jednotlivých xxxxxxxx norem xxxxxx xxxxxxxx předpisů x xxxxxxxx xxxx xxxxxxxxxxxxx, xxxxx xx jich xxxxxx xxxxxxxxx změna xxxxx uvedeného xxxxxxxx xxxxxxxx.