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 xxxxxxxxxx xxxxx xxx xxxxxxxxxx, xxxxxxxx a xxxxxxxxx xxxxxxxx pro rok 2024
&xxxx;

Xxxxxxxxxxxx xxxxxxxxxxxxx podle §80 odst. 1 xxxx. e) xxxxxx x. 258/2000 Xx., x ochraně xxxxxxxxx xxxxxx x x xxxxx xxxxxxxxx xxxxxxxxxxxxx xxxxxx, ve xxxxx xxxxxxxxxx xxxxxxxx, xxxxxxx xx xxxxxxx xxxxxxxxxx Xxxxxxx xxxxxxxxxx komise xxxxxxxxx složení očkovacích xxxxx xxx xxxxxxxxxx, xxxxxxxx a mimořádná xxxxxxxx xxx xxx 2024:

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

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

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

Xxxxxxxxxxx anatoxinum¹ ne xxxx xxx 30 mezinárodních xxxxxxxx (XX)

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

Xxxxxxxx Xxxxxxxxxx xxxxxxxxx:

Xxxxxxxxx xxxxxxxxxx (XX)¹&xxxx;25 mikrogramů

Pertussis xxxxxxxxxxxxxxxx xxxxxxxxxxxx (FHA)¹ 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 XXX-1)⁴&xxxx;8 X xxxxxxxx antigenu

typus 3 (xxxx Saukett)⁴ 32 X xxxxxxxx xxxxxxxx

Xxxxxxxxxxx xxxxxxxxxx xxxxx b polysaccharidum

(Polyribosylribitoli xxxxxxxx) 10 xxxxxxxxxx

xxxx. xxx xxxxxx. xxxxxxxx xxxx nosný xxxxxxx xxxxxxxxx 25 xxxxxxxxxx

¹&xxxx;xxxxxxxxxxx xx xxxxxxxx hlinitý, xxxxxxxxxxx (Xx(XX)₃) 0,5 xxxxxxxxx Xx³⁺

²&xxxx;xxxxxxxx xxxxxxxxxxxxx XXX xxxxxxxxxxx xx xxxxxxx kvasinkových xxxxx (Xxxxxxxxxxxxx xxxxxxxxxx)

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

⁴&xxxx;xxxxxxxxx xx XXXX xxxxxxx

XXXX

1xx)&xxxx;xxxxxxxxxxx xxxxxxxx xxxxx xxxxx xxxxxxx, dávivému kašli (xxxxxxxxxx xxxxx), xxxxxx, xxxxxx přenosné xxxxx (xxxxxxxxxxxx xxxxx), virové xxxxxxxxxx X, nákazám xxxxxxxxx Haemophilus xxxxxxxxxx xxx b (XXxXXxxXXXXXX)

Xxxxx xxxxx¹&xxxx;(0,5 ml) obsahuje:

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

Tetani anatoxinum 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 antigenu⁴

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

xxxxx 3 (Xxxxxxx) 32 X jednotek antigenu⁴

Antigenum xxxxxxxxx xxxxxxxxxxx B⁵ 10 xxxxxxxxxx

Xxxxxxxxxxxxxxxxxxx xxxxxxxx haemophili xxxxxxxxxx B 12 xxxxxxxxxx

(Xxxxxxxxxxxxxxxxxxx phosphas)

conjugata xxx xxxxxx xxxxxxxxxx 22-36 xxxxxxxxxx

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

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

³ pomnoženo na XXXX buňkách

⁴ nebo ekvivalentní xxxxxxxx antigenu stanovené xxxxxxx xxxxxxxxxxxxxx metodou

⁵ vyrobeno xxxxxxxxxxxxx XXX xxxxxxxxxxx x xxxxxxxxxxxx xxxxxxx Xxxxxxxxx xxxxxxxxxx

XXXX

1xx)&xxxx;Xxxxxxx proti xxxxxxx, xxxxxx, dávivému xxxxx (acelulární komponenta), xxxxxxxxxx X (xXXX), xxxxxx xxxxxxxx xxxxx (xxxxxxxxxxxx) x konjugovaná xxxxxxx xxxxx Haemophilus xxxx b (xxxxxxxxxxx)

Xxxxx xxxxx (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx anatoxinum¹ ne méně xxx 20 XX

Xxxxxx xxxxxxxxxx¹&xxxx;xx xxxx xxx 40 XX

Xxxxxxxx Bordetellae xxxxxxxx¹

Xxxxxxxxx xxxxxxxxxx (PT) 20 xxxxxxxxxx

Xxxxxxxxxxxxxxx xxxxxxxxxxxx (XXX) 20 xxxxxxxxxx

Xxxxxxxxxxx (XXX) 3 mikrogramy

Fimbriae 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 D jednotek xxxxxxxx⁵

Xxxxx 2 (XXX-1) 8 X jednotek xxxxxxxx⁵

Xxxxx 3 (Xxxxxxx) 32 X jednotek xxxxxxxx⁵

Xxxxxxxxxxxxxx Haemophili xxxxxxxxxx xxxxx x

(Xxxxxxxxxxxxxxxxxxx phosphas) 3 mikrogramy xxxxxxxxxx xxx xxxxxxxxx meningococci xxxxx x²&xxxx;50 mikrogramů

¹ adsorbováno xx fosforečnan hlinitý (0,17 xx Xx³⁺)

²&xxxx;xxxxxxxxxxx xx xxxxxxxxxxx xxxxxxxx xxxxxxx sulfát (0,15 xx Al³⁺)

³ vyrobeno xxxxxxxxxxxxx XXX xxxxxxxxxxx x xxxxxxxxxxxx buňkách 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 (acelulární xxxxx), xxxxxx (XXxX)

Xxxxx xxxxx (0,5 ml) xxxxxxxx xxxx léčivé látky:

Diphtheriae xxxxxxxxxx* ≥ 30 XX

Xxxxxx xxxxxxxxxx* ≥ 40 XX

Xxxxxxxxx anatoxinum* (XX) 25 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxxxxx* (FHA) 25 xxxxxxxxxx

Xxxxxxxxxxx* (69kD) 8 xxxxxxxxxx

*&xxxx;xxxxxxxxxxx na xxxxxxxx hlinitý xxxxxx: 0,5 miligramů

NEBO

1ba) Očkovací látka xxxxx xxxxxxx, xxxxxx x xxxxxxxx kašli (xxxxxxxxxx) xx sníženým 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 xxxxxxx xxxxxxxxx xxxxxxxxxxxxx (p = 0,95) xxxxxxxx xxxxxx xxxxx xxxxx xxxxxxxxx x Xxxxxxxxx xxxxxxxx.

XXXX

1xx)&xxxx;Xxxxxxxx látka proti xxxxxxx, tetanu x xxxxxxxx xxxxx (acelulární xxxxxxxxxx) se xxxxxxxx xxxxxxx xxxxxxxx (Xxxx)

Xxxxx xxxxx (0,5 xx) xxxxxxxx:

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

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

Xxxxxxxxxxx xxxxxxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxxx¹&xxxx;8 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxx xxxxxxxxxxxx¹&xxxx;8 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxx xxxxxxxx xxxxxxxxx¹&xxxx;2,5 mikrogramu

¹ adsorbováno xx hydratovaný hydroxid xxxxxxx (Xx(XX)₃) 0,3 xxxxxxxxx Al³⁺ a xxxxxxxxxxx xxxxxxx (XXXX₄) 0,2 xxxxxxxxx Al³⁺

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

Xxxxx dávka xxxxxxxxxxxxx xxxxxxx obsahuje:

Polysaccharidum Xxx xxxxxxxxxxx (10 xxxxxxxxxx) xxx Anatoxino tetanico (xxxxxxxxx 25 mikrogramu).

1d) očkovací xxxxx proti tetanu:

Jedna xxxxx xxxxxxxx:

Xxxxxx xxxxxxxxxx - xxx. 40 xxxxxxxxxxxxx xxxxxxxx

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

Xxxxx xxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx B - 10 xxxxxxxxxx

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

Xxxxx dávka xxxxxxxx:

Xxxxxxxxx xxxxxxxxx hepatitidis X - 20 xxxxxxxxxx

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

Xxxxx dávka xxxxxxxx:

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

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

Rubeolae xxxxx xxxxxxxxxx²&xxxx;(Xxxxxx RA 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 xxxxxxx (XXX-5)

³&xxxx;50% xxxxxxxx dávka xxxxxxx xxxxxxx

XXXX

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

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

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

Xxxxx parotitidis¹ vivum attenuatum (xxxx Xxxxx Xxxx™, xxxxxxx B) ne xxxx xxx 12,5x10³&xxxx;XXXX₅₀*

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

*&xxxx;50% xxxxxxxx xxxxx xxxxxxx kultury

¹ vyrobeno na xxxxxxx xxxxxxxx embryí.

² vyrobeno xx xxxxxxxx xxxxxxxxxxx xxxxxxxx XX-38 fibroblastech.

1h) očkovací xxxxx xxxxx xxxxxx xxxxxxxx obrně v xxxxxxxxxxxx xxxxx:

Xxxxx xxxxx xxxxxxxx:

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

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

Xxxxx xxxxxxxxxxxxx xxxxxxxxxxx typus 3 (Xxxxxxx) ........ 32 xxxxxxxxxxx X xxxxxxxx*

*&xxxx;xxxx množství ekvivalentních xxxxxxxx stanovené pomocí xxxxxx xxxxxxxxxxxxx metody.

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

1xxx)&xxxx;xxxxxxxxxxx xxxxxxxx xxxxx xxxxxxxx:

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 1^l 2,2 μx

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

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

Streptococci xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 5¹ 2,2 μx

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

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

Streptococci pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 7F¹ 2,2 μx

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

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

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

Xxxxxxxxxxxx xxxxxxxxxx polysaecharidum xxxxxxxxx 19A¹ 2,2 μx

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

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 23F¹ 2,2 μx

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

X

1xxx)&xxxx;xxxxx xxxxxxxxxxxxx xxxxxxxx

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

XXXX

1xxx)&xxxx;xxxxxxxxxxx xxxxxxxx látka xxxxx pneumokokovým infekcím

Jedna xxxxx (0,5 ml) xxxxxxxx:

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

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

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

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

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

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

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

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

polysacharid xxxxxxxx (xxxxxxxxxx) Streptococcus xxxxxxxxxx xxxxxxxx 9X&xxxx;^1,2&xxxx;2,2 μx

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

xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 11A ^1,2 2,2 μx

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

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

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

xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Streptococcus xxxxxxxxxx sérotypu 18C ^1,2 2,2 μx

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

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

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

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

polysacharid xxxxxxxx (xxxxxxxxxx) Streptococcus xxxxxxxxxx xxxxxxxx 33X&xxxx;^1,2&xxxx;2,2 μg

¹ Xxxxxxxxxx s nosným xxxxxxxxx CRM₁₉₇ (přibližně 51 μx xx xxxxx)

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

1i) očkovací xxxxx proti xxxxxxx, xxxxxxxx kašli (xxxxxxxxxx xxxxx), tetanu, xxxxxx xxxxxxxx xxxxx (xxxxxxxxxxxx xxxxx):

Xxxxx dávka (0,5 xx) xxxxxxxx:

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

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

Xxxxxxxxxxx pertussis xxxxxxxx:

Xxxxxxxxx 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 X xxxxxxxx antigenu

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

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

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

² xxxxxxxxx xx XXXX xxxxxxx

XXXX

1xx)&xxxx;xxxxxxxx látka xxxxx xxxxxxx, xxxxxxxx xxxxx (xxxxxxxxxx xxxxx), xxxxxx, dětské přenosné xxxxx (inaktivovaná xxxxx):

Xxxxx xxxxx (0,5 xx) xxxxxxxx:

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

Xxxxxx xxxxxxxxxx xxxxxxxxx 20 IU* (5 Xx)

Xxxxxxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxxx 2,5 xxxxxxxxxx

Xxxxxxxxx haemagglutininum xxxxxxxxxxxx 5 mikrogramů

Pertactinum 3 xxxxxxxxxx

Xxxxxxxx, typi 2 xx 3 5 xxxxxxxxxx

Xxxxx poliomyelitidis (xxxxxxxxxxx)**

xxxxx 1 40 X xxxxxxxx antigenu

ty xxx 2 8 X xxxxxxxx xxxxxxxx

xxxxx 3 32 X xxxxxxxx antigenu

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

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

**&xxxx;Xxxxxxxxxxx xx Vero xxxxxxx.

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

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

Xxxxx dávka (0,5 xx) xxxxxxx xxxxxxxx:

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

¹ xxxxxxxxxx xx AS04C xxxxxxxxxx: - 3-O-deacyl-4'-monofosforyl-lipid X (MPL)² 50 xxxxxxxxxx

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

³ xxxxxxxx xx kultuře xxxxxxxxxxxx xxxxx (Xxxxxxxxxxxxx cerevisiae) xxxxxxxxxxxxx DNA technologií.

2. Antigenní xxxxxxx xxxxxxxxxx xxxxx xxx zvláštní očkování

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

Xxxxx xxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx B - 20 xxxxxxxxxx

2x)&xxxx;xxxxxxxx xxxxx xxxxx xxxxxxxxx

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

Jedna xxxxx xxxxxxxx:

Xxxxxxxxx X xxxxx xxxxxxxxxxx

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

Xxxxx xxxxx xxxxxxxx:

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

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

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

¹&xxxx;xxxxxxxxx xx xxxxxxx kuřecích xxxxxx

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

³&xxxx;50% xxxxxxxx xxxxx 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 Xxxxxx’ Xxxxxxxxx) xx méně xxx 1x10³&xxxx;XXXX₅₀*

Xxxxx parotitidis¹ vivum attenuatum (xxxx Xxxxx Xxxx™, xxxxxxx X) xx xxxx xxx 12,5x10³&xxxx;XXXX₅₀*

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

*&xxxx;50% infekční xxxxx xxxxxxx kultury

¹ vyrobeno xx xxxxxxx xxxxxxxx embryí.

² vyrobeno xx xxxxxxxx diploidních xxxxxxxx XX-38 xxxxxxxxxxxxx.

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

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

Virus xxxxxxxxx X inactivatum

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

Virus xxxxxxxxx A inactivatum

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

Jedna 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 pro xxxxxxxx xxxxxxx₅₀³

Xxxxxxxx virus attenuatum² (Wistar XX 27/3) min. 10^3,0&xxxx;xxxxxxxx dávka xxx xxxxxxxx kulturu₅₀³

¹ pomnoženo na xxxxxxx kuřecích embryí

² pomnoženo xx lidských xxxxxxxxxxx xxxxxxx (MRC-5)

³ 50% xxxxxxxx xxxxx tkáňové xxxxxxx

XXXX

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

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

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

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

Xxxxx xxxxxxxx²&xxxx;xxxxx xxxxxxxxxx (kmen Wistar XX 27/3) xx 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. Válek, XXx, XXX, XXXX, x. x.

Xxxxxxxxx

Xxxxxx xxxxxxx x. 420/2023 Sb. nabyl xxxxxxxxx xxxx 29.12.2023.

Ke xxx xxxxxxxx xxxxxx xxxxxxx nebyl xxxxx xx doplňován.

Znění xxxxxxxxxxxx xxxxxxxx xxxxx xxxxxx xxxxxxxx xxxxxxxx x xxxxxxxx xxxx aktualizováno, xxxxx xx xxxx xxxxxx xxxxxxxxx xxxxx xxxxx xxxxxxxxx xxxxxxxx xxxxxxxx.