Plné znění - 375/2024 Sb.

Sdělení Ministerstva zdravotnictví o antigenním složení očkovacích látek pro pravidelná, zvláštní a mimořádná očkování pro rok 2025

375/2024 Sb.
 

Sdělení Ministerstva zdravotnictví

INFORMACE

375

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Xxxxxxxxxxxx xxxxxxxxxxxxx

xx dne 5. xxxxxxxx 2024

x xxxxxxxxxx xxxxxxx xxxxxxxxxx xxxxx xxx xxxxxxxxxx, xxxxxxxx a xxxxxxxxx xxxxxxxx xxx xxx 2025
&xxxx;

Xxxxxxxxxxxx zdravotnictví podle §80 xxxx. 1 xxxx. x) zákona x. 258/2000 Xx., x ochraně xxxxxxxxx xxxxxx a o xxxxx některých souvisejících xxxxxx, ve xxxxx xxxxxxxxxx xxxxxxxx, xxxxxxx xx xxxxxxx xxxxxxxxxx Xxxxxxx xxxxxxxxxx xxxxxx xxxxxxxxx xxxxxxx xxxxxxxxxx xxxxx xxx pravidelná, xxxxxxxx x mimořádná xxxxxxxx pro rok 2025:

1. Xxxxxxxxx xxxxxxx xxxxxxxxxx xxxxx xxx xxxxxxxxxx xxxxxxxx

1x) xxxxxxxxxxx xxxxxxxx látka proti xxxxxxx, xxxxxxxx xxxxx (xxxxxxxxxx xxxxx), xxxxxx, xxxxxx xxxxxxxx xxxxx (xxxxxxxxxxxx forma), virové xxxxxxxxxx X, xxxxxxx xxxxxxxxx Xxxxxxxxxxx xxxxxxxxxx xxx b (XXxXXxxXXXXXX)

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

Xxxxxxxxxxx xxxxxxxxxx¹ xx méně xxx 30 xxxxxxxxxxxxx xxxxxxxx (XX)

Xxxxxx xxxxxxxxxx1 xx xxxx xxx 40 xxxxxxxxxxxxx xxxxxxxx (XX)

Xxxxxxxx Xxxxxxxxxx pertussis:

Pertussis xxxxxxxxxx (PT)¹ 25 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxxxx filamentosum (XXX)¹ 25 xxxxxxxxxx

Xxxxxxxxxxx (XXX)¹ 8 mikrogramů

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

Xxxxx xxxxxxxxxxxxxxx xxxxxxxxxxx (XXX)

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

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

xxxxx 3 (kmen Xxxxxxx)⁴ 32 X jednotek xxxxxxxx

Xxxxxxxxxxx influenzae typus x xxxxxxxxxxxxxxx

(Xxxxxxxxxxxxxxxxxxx xxxxxxxx) 10 xxxxxxxxxx

xxxx. cum xxxxxx. tetanico xxxx xxxxx protein přibližně 25 xxxxxxxxxx

¹ adsorbováno xx xxxxxxxx hlinitý, xxxxxxxxxxx (Al(OH)₃) 0,5 xxxxxxxxx Al³⁺

² vyrobeno xxxxxxxxxxxxx DNA technologií xx kultuře kvasinkových xxxxx (Saccharomyces xxxxxxxxxx)

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

⁴ pomnoženo xx VERO xxxxxxx

XXXX

1xx) xxxxxxxxxxx očkovací látka xxxxx záškrtu, xxxxxxxx xxxxx (xxxxxxxxxx xxxxx), xxxxxx, dětské xxxxxxxx xxxxx (xxxxxxxxxxxx xxxxx), xxxxxx hepatitidě B, xxxxxxx xxxxxxxxx Xxxxxxxxxxx xxxxxxxxxx xxx x (XXxXXxxXXXXXX)

Xxxxx xxxxx¹ (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx xxxxxxxxxx xx méně než 20 xxxxxxxxxxxxx jednotek (XX)^2,4 (30 Lf)

Tetani xxxxxxxxxx xx méně xxx 40 xxxxxxxxxxxxx xxxxxxxx (XX)^3,4 (10 Xx)

Xxxxxxxx Xxxxxxxxxx xxxxxxxxx

Xxxxxxxxx xxxxxxxxxx 25 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxxxx xxxxxxxxxxxx 25 xxxxxxxxxx

Xxxxx Xxxxxxxxxxxxxxx (xxxxxxxxxxxx)⁵

xxxxx 1 (Xxxxxxx) 29 X xxxxxxxx antigenu⁶

typus 2 (XXX-1) 7 X xxxxxxxx antigenu⁶

typus 3 (Xxxxxxx) 26 X xxxxxxxx antigenu⁶

Tegiminis xxxxxxxxxxx X xxxxxxxxx⁷ 10 xxxxxxxxxx

Xxxxxxxxxx xxxxxxxxxx xxxx B xxxxxxxxxxxxxxx (Xxxxxxxxxxxxxxxxxxx xxxxxxxx) 12 xxxxxxxxxx xxxxxxxxxx cum xxxxxx xxxxxxxx 22-36 xxxxxxxxxx

¹ Xxxxxxxxxxx xx xxxxxxxxxxx hydroxid xxxxxxx (0,6 xx Xx³⁺)

² Xxxx xxxxxx mez xxxxxxxxxxxxx (p = 0,95) x xx xxxx xxx 30 XX xxxx xxxxxxx xxxxxxx

³ Xxxx xxxxxx xxx xxxxxxxxxxxxx (x = 0,95)

⁴ Nebo xxxxxxxxxxxx xxxxxxxx xxxxxxxxx xxxxxxxxxx xxxxxxxxxxx

⁵ Kultivováno xx Xxxx xxxxxxx

⁶ Xxxx množství antigenu xxxx úplně xxxxxx xxxx ta, xxxxx xxxx xxxxx xxxxxxxxx xxxx 40-8-32 X xxxxxxxx xxxxxxxx xxx xxxxx xxxx 1, 2 a 3, xxx měření jinou xxxxxxx xxxxxxxxxxxxxx xxxxxxx

⁷ xxxxxxxx rekombinantní DNA xxxxxxxxxxx x xxxxxxxxxxxx xxxxxxx Xxxxxxxxx xxxxxxxxxx

XXXX

1xx) Xxxxxxx proti xxxxxxx, xxxxxx, xxxxxxxx xxxxx (xxxxxxxxxx xxxxxxxxxx), xxxxxxxxxx X (xXXX), dětské xxxxxxxx obrně (inaktivovaná) x konjugovaná vakcína xxxxx Haemophilus xxxx x (xxxxxxxxxxx)

Xxxxx xxxxx (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx xxxxxxxxxx1 ne xxxx xxx 20 XX⁶

Xxxxxx xxxxxxxxxx1 ne xxxx xxx 40 IU⁶

Antigena Xxxxxxxxxxx xxxxxxxx¹

Xxxxxxxxx anatoxinum (XX) 20 xxxxxxxxxx

Xxxxxxxxxxxxxxx xxxxxxxxxxxx (FHA) 20 xxxxxxxxxx

Xxxxxxxxxxx (XXX) 3 xxxxxxxxxx

Xxxxxxxx xxxx 2 xx 3 (XXX) 5 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx X ^2,3 10 mikrogramů

Virus xxxxxxxxxxxxxxx (xxxxxxxxxxx)⁴

Xxxxx 1 (Mahoney) 40 D xxxxxxxx xxxxxxxx⁵

Xxxxx 2 (XXX-1) 8 X jednotek xxxxxxxx⁵

Xxxxx 3 (Xxxxxxx) 32 D xxxxxxxx xxxxxxxx⁵

Xxxxxxxxxxxxxx Haemophili xxxxxxxxxx xxxxx x

(Xxxxxxxxxxxxxxxxxxx phosphas) 3 mikrogramy xxxxxxxxxx xxx xxxxxxxxx meningococci xxxxx x² 50 xxxxxxxxxx

¹ xxxxxxxxxxx xx xxxxxxxxxxx hlinitý (0,17 xx Al³⁺)

² xxxxxxxxxxx xx hydratovaný xxxxxxxx xxxxxxx xxxxxx (0,15 xx Xx³⁺)

³ xxxxxxxx xxxxxxxxxxxxx XXX xxxxxxxxxxx x xxxxxxxxxxxx xxxxxxx Xxxxxxxxxxxxx xxxxxxxxxx

⁴ xxxxxxxxx xx Xxxx xxxxxxx

⁵ xxxx ekvivalentní xxxxxxxx xxxxxxxx xxxxxxxxx vhodnou xxxxxxxxxxxxxx xxxxxxx

⁶ nebo xxxxxxxxxxxx xxxxxxxx stanovená xxxxxxxxxxxx xxxxxxxxxxx

1x) očkovací xxxxx proti záškrtu, xxxxxxxx xxxxx (xxxxxxxxxx xxxxx), xxxxxx (DTaP)

Jedna xxxxx (0,5 xx) xxxxxxxx tyto xxxxxx xxxxx:

Xxxxxxxxxxx anatoxinum* ≥ 30 IU

Tetani xxxxxxxxxx* ≥ 40 IU

Pertussis xxxxxxxxxx* (XX) 25 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxxxxx* (XXX) 25 xxxxxxxxxx

Xxxxxxxxxxx* (69xX) 8 xxxxxxxxxx

* xxxxxxxxxxx xx xxxxxxxx xxxxxxx celkem: 0,5 xxxxxxxxx

XXXX

1xx) Xxxxxxxx xxxxx xxxxx xxxxxxx, tetanu x dávivému kašli (xxxxxxxxxx) xx xxxxxxxx xxxxxxx xxxxxxxx (Xxxx)

Xxxxx xxxxx (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx anatoxinum - Xxxxxxxxx 2 XX* (2 Xx)

Xxxxxx xxxxxxxxxx - Minimálně 20 XX* (5 Xx)

Xxxxxxxxx xxxxxxxx

Xxxxxxxxx xxxxxxxxxx - 2,5 mikrogramů

Haemagglutinum xxxxxxxxxxxx - 5 mikrogramů

Pertactinum - 3 xxxxxxxxxx

Xxxxxxxx, xxxx 2 xx 3 - 5 xxxxxxxxxx

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

* Xxxx spodní xxxxxxx xxxxxxxxx spolehlivosti (x = 0,95) xxxxxxxx xxxxxx podle xxxxx popsaného x Xxxxxxxxx xxxxxxxx

XXXX

1xx) Xxxxxxxx xxxxx xxxxx xxxxxxx, xxxxxx x dávivému xxxxx (xxxxxxxxxx komponenta) xx xxxxxxxx xxxxxxx xxxxxxxx (Xxxx)

Xxxxx xxxxx (0,5 ml) xxxxxxxx:

Xxxxxxxxxxx xxxxxxxxxx¹ ne méně xxx 2 xxxxxxxxxxx xxxxxxxx (XX) (2,5 Xx)

Xxxxxx xxxxxxxxxx¹ ne xxxx xxx 20 xxxxxxxxxxxxx jednotek (IU) (5 Xx)

Xxxxxxxxxxx xxxxxxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxxx¹ 8 xxxxxxxxxx

Xxxxxxxxx haemagglutinum filamentosum¹ 8 xxxxxxxxxx

Xxxxxxxxxxx¹ 2,5 xxxxxxxxxx

¹ xxxxxxxxxxx xx xxxxxxxxxxx xxxxxxxx xxxxxxx (X1(XX)₃) 0,3 miligramů Xx³⁺ x xxxxxxxxxxx xxxxxxx (AlPO₄) 0,2 xxxxxxxxx Xx³⁺

1x) xxxxxxxx xxxxx xxxxx xxxxxxx xxxxxxxxx Haemophilus xxxxxxxxxx xxx x:

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

Xxxxxxxxxxx influenzae xxxxx x xxxx xxxxxxxxxxx 10 xxxxxxxxxx

xxxxxxxxxxx x tetanickým toxoidem xxxx xxxxxxxxxxx nosičem xxxxxxxxx 25 xxxxxxxxxx

1x) xxxxxxxx xxxxx proti xxxxxx:

Xxxxx xxxxx xxxxxxxx:

Xxxxxx xxxxxxxxxx - min. 40 mezinárodních xxxxxxxx

1x) xxxxxxxx látka xxxxx xxxxxx hepatitidč B x dětské xxxxxxx:

Xxxxx xxxxx obsahuje:

Antigenum xxxxxxxxx xxxxxxxxxxx B - 10 xxxxxxxxxx

1x) xxxxxxxx xxxxx proti virové xxxxxxxxxx X x xxxxxxx xxxxxxx

Xxxxx xxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx X - 20 xxxxxxxxxx

1x) očkovací látka xxxxx xxxxxxxxxx, xxxxxxxxxx x xxxxxxxxx:

xxxxx xxxxxxxxxxxxxxx xxxxxxx (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx virus xxxxxxxxxx¹ (Xxxxxxx) min. 10^3,0 xxxxxxxx dávka xxx xxxxxxxx xxxxxxx₅₀³

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

Xxxxxxxx virus attenuatum² (Xxxxxx XX 27/3) xxx. 10^3,0 infekční xxxxx pro xxxxxxxx xxxxxxx₅₀³

¹ pomnoženo xx xxxxxxx xxxxxxxx xxxxxx

² xxxxxxxxx xx xxxxxxxx xxxxxxxxxxx xxxxxxx (XXX-5)

³ 50% xxxxxxxx xxxxx xxxxxxx kultury

NEBO

1ga) xxxxxxxx xxxxx proti xxxxxxxxxx, xxxxxxxxxx x xxxxxxxxx

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

Virus xxxxxxxxxxx¹ xxxxx attenuatum (xxxx Enders’ Xxxxxxxxx) xx xxxx xxx 1x10³ CCID₅₀*

Virus parotitidis¹ xxxxx xxxxxxxxxx (xxxx Xxxxx Lynn™, xxxxxxx X) xx xxxx xxx 12,5x10³ CCID₅₀*

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

* 50% xxxxxxxx xxxxx xxxxxxx xxxxxxx

¹ xxxxxxxx xx xxxxxxx xxxxxxxx xxxxxx.

² vyrobeno na xxxxxxxx diploidních xxxxxxxx XX-38 xxxxxxxxxxxxx

1x) xxxxxxxx xxxxx proti xxxxxx xxxxxxxx xxxxx v xxxxxxxxxxxx formě:

Jedna dávka (0,5 xx) xxxxxxxx:

Xxxxx xxxxxxxxxxxxx xxxxxxxxxxx xxxxx 1 (Mahoney) ... 29 antigenních D xxxxxxxx**

Xxxxx xxxxxxxxxxxxx inactivatum xxxxx 2 (MEF-1) ... 7 antigenních X xxxxxxxx**

Xxxxx poliomyelitis xxxxxxxxxxx xxxxx 3 (Xxxxxxx) ) ... 26 xxxxxxxxxxx X xxxxxxxx**

* Xxxxxxxxxxx xx XXXX xxxxxxx

** Xxxx xxxxxxxx xxxxxxxx xxxx xxxxx stejná xxxx xx, xxxxx byla xxxxx xxxxxxxxx jako 40-8-32 D xxxxxxxx xxxxxxxx xxx xxxxx xxxx 1, 2 x 3, xxx xxxxxx jinou xxxxxxx xxxxxxxxxxxxxx metodou

1ch) xxxxxxxxxxx xxxxxxxx xxxxx xxxxx xxxxxxxxxxxxx xxxxxxxx

Xxxxx xxxxx (0,5 ml) obsahuje:

Polysacharid xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 1 ^1,2 2,2 µx

xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Streptococcus xxxxxxxxxx xxxxxxxx 3 ^1,2 2,2 µx

xxxxxxxxxxxx xxxxxxxx (pneumokoka) Streptococcus xxxxxxxxxx sérotypu 4 ^1,2 2,2 µx

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

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

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

polysacharid xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx sérotypu 7X ^1,2 2,2 µg

polysacharid xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx sérotypu 8 ^1,2 2,2 µx

xxxxxxxxxxxx xxxxxxxx (pneumokoka) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 9 X ^1,2 2,2 µx

xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx pneumoniae xxxxxxxx 10X ^1,2 2,2 µx

xxxxxxxxxxxx bakterie (pneumokoka) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 11X ^1,2 2,2 µx

xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 12X ^1,2 2,2 µx

xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx pneumoniae sérotypu 14 ^1,2 2,2 µx

xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx pneumoniae xxxxxxxx 15X ^1,2 2,2 µx

xxxxxxxxxxxx bakterie (xxxxxxxxxx) Xxxxxxxxxxxxx pneumoniae xxxxxxxx 18X ^1,2 2,2 µx

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

xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx pneumoniae sérotypu 19X ^1,2 2,2 µx

xxxxxxxxxxxx bakterie (pneumokoka) Xxxxxxxxxxxxx pneumoniae sérotypu 22X ^1,2 2,2 µx

xxxxxxxxxxxx xxxxxxxx (pneumokoka) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 23X ^1,2 2,2 µx

xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx pneumoniae xxxxxxxx 33X ^1,2 2,2 µx

1 Xxxxxxxxxx x xxxxxx xxxxxxxxx XXX₁₉₇ (xxxxxxxxx 51 µg xx dávku)

2 Adsorbován xx xxxxxxxxxxx xxxxxxx (0,125 xx hliníku xx xxxxx)

XXXX

1xxx) očkovací xxxxx xxxxx pneumokokovým xxxxxxxx xxxxxxxxx v xxxxxxxxxx xxxxxxxx:

1xxxx) xxxxxxxxxxx xxxxxxxx xxxxx xxxxxxxx:

Xxxxxxxxxxxx xxxxxxxxxx serotypi 1^1,2 xxxxxxxxxxxxxxx 2,0 mikrogramů

Streptococci xxxxxxxxxx serotypi 3^1,2 xxxxxxxxxxxxxxx 2,0 mikrogramů

Streptococci xxxxxxxxxx xxxxxxxx 4^1,2 xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx

Xxxxxxxxxxxx xxxxxxxxxx serotypi 5^1,2 xxxxxxxxxxxxxxx 2,0 mikrogramů

Streptococci xxxxxxxxxx serotypi 6X^1,2 xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 6X^1,2 xxxxxxxxxxxxxxx 4,0 xxxxxxxxxx

Xxxxxxxxxxxx xxxxxxxxxx serotypi 7X^1,2 xxxxxxxxxxxxxxx 2,0 mikrogramů

Streptococci xxxxxxxxxx xxxxxxxx 9X^1,2 xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 14^1,2 xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx

Xxxxxxxxxxxx xxxxxxxxxx serotypi 18X^1,2 xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 19X^1,2 xxxxxxxxxxxxxxx 2,0 mikrogramů

Streptococci xxxxxxxxxx xxxxxxxx 19F^1,2 xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 22X^1,2 xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 23X^1,2 xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 33X^1,2 xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx

¹ Xxxxxxxxxx x proteinovým xxxxxxx XXX₁₉₇, XXX₁₉₇ xx xxxxxxxxx mutace xxxxxxxxxxxx xxxxxx (xxxxxxxxxxxxx x Xxxxxxxxxxxxxxx xxxxxxxxxxx X7) xxxxxxxxxxxxx exprimováného x Pseudomonas xxxxxxxxxxx

² Xxxxxxxxxx xx xxxxxxxx xxxxxxxxxxx xxxxxxx

X

1xxxx) xxxx xxxxxxxxxxx očkovací xxxxx xxxxxxxx:

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

XXXX

1xxx) očkovací xxxxx xxxxx pneumokokovým xxxxxxxx xxxxxxxxx v sekvenčním xxxxxxxx:

1xxxx) konjugovaná xxxxxxxx xxxxx obsahuje:

Streptococci xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 1¹ 2,2µx

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 3¹ 2,2 µx

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 4¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum xxxxxxxxx 5¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 6X¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum xxxxxxxxx 6X¹ 4,4 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 7X¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum xxxxxxxxx 9X¹ 2,2 µx

Xxxxxxxxxxxx pneumoniae polysaccharidum xxxxxxxxx 14¹ 2,2 µx

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 18C¹ 2,2 µx

Xxxxxxxxxxxx pneumoniae polysaccharidum xxxxxxxxx 19X¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 19X¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum xxxxxxxxx 23F¹ 2,2 µx

¹ Xxxxxxxxxx x xxxxxx proteinem XXX₁₉₇ x adsorbován na xxxxxxxxxxx xxxxxxx (0,125 xx xxxxxxx)

X

1xxxx) xxxx xxxxxxxxxxx očkovací xxxxx xxxxxxxx:

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

1x) očkovací xxxxx xxxxx záškrtu, xxxxxxxx xxxxx (xxxxxxxxxx xxxxx), xxxxxx, xxxxxx xxxxxxxx xxxxx (inaktivovaná xxxxx):

Xxxxx xxxxx (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx xxxxxxxxxx¹ - xx méně xxx 2 xxxxxxxxxxx xxxxxxxx (XX) (2,5 Lf)

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

Xxxxxxxxxxx xxxxxxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxxx¹ - 8 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxx xxxxxxxxxxxx¹ - 8 mikrogramů

Pertaktin1 2,5 mikrogramů

Virus xxxxxxxxxxxxxxx xxxxxxxxxxx:

xxxxx 1 (kmen Xxxxxxx)² 40 X xxxxxxxx xxxxxxxx

xxxxx 2 (xxxx XXX-1)² 8 X xxxxxxxx antigenu

typus 3 (xxxx Xxxxxxx)² 32 X jednotek xxxxxxxx

¹ adsorbováno xx xxxxxxxxxxx xxxxxxxx xxxxxxx (Xx(XX)₃) 0,3 xxxxxxxxx Xx³⁺ a xxxxxxxxxxx xxxxxxx (XxXX₄) 0,2 xxxxxxxxx Xx³⁺

² pomnoženo xx VERO xxxxxxx

XXXX

1xx) xxxxxxxx látka xxxxx xxxxxxx, dávivému kašli (xxxxxxxxxx xxxxx), xxxxxx, xxxxxx xxxxxxxx xxxxx (xxxxxxxxxxxx xxxxx):

Xxxxx dávka (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx xxxxxxxxxx xxxxxxxxx 2 XX¹ (2 Lf)

Tetani xxxxxxxxxx xxxxxxxxx 20 XX¹ (5 Xx)

Xxxxxxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxxx 2,5 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxxxx filamentosum 5 mikrogramů

Pertactinum 3 xxxxxxxxxx

Xxxxxxxx, xxxx 2 xx 3 5 xxxxxxxxxx

Xxxxx xxxxxxxxxxxxxxx (xxxxxxxxxxx)²

xxxxx 1 (Xxxxxxx) 29 X xxxxxxxx xxxxxxxx³

xxxxx 2 (MEF1) 7 X jednotek xxxxxxxx³

xxxxx 3 (Xxxxxxx) 26 X xxxxxxxx xxxxxxxx³

Xxxxxxxxxxx xx fosforečnan xxxxxxx 1,5 mg (0,33 xx Xx³⁺)

¹ Xxxx xxxxxx xxxxxxx intervalu xxxxxxxxxxxxx (p = 0,95) aktivity měřené xxxxx testu xxxxxxxxx x Evropském xxxxxxxx

² Xxxxxxxxxxx na Vero xxxxxxx

³ Xxxx množství xxxxxxxx jsou úplně xxxxxx jako xx, xxxxx xxxx dříve xxxxxxxxx xxxx 40-8-32 X xxxxxxxx antigenu xxx xxxxx xxxx 1, 2 x 3, xxx xxxxxx xxxxx xxxxxxx xxxxxxxxxxxxxx xxxxxxx

* Xxxx xxxxxx xxxxxxx xxxxxxxxx xxxxxxxxxxxxx (x = 0,95) xxxxxxxx xxxxxx podle xxxxx xxxxxxxxx x Xxxxxxxxx lékopisu

** Xxxxxxxxxxx xx Vero xxxxxxx.

1x) xxxxxxxx xxxxx xxxxx xxxxxxxxxxx (BCG vakcína)

1k) xxxxxxxx xxxxx proti xxxxxx xxxxxxxxxx B xxx xxxxx xxxxxxxx xx dialyzačního programu:

Jedna xxxxx (0,5 xx) xxxxxxx obsahuje:

Antigenum xxxxxxxxx xxxxxxxxxxx X^1,2,3 - 20 xxxxxxxxxx

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

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

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

2. Xxxxxxxxx xxxxxxx očkovacích xxxxx xxx xxxxxxxx xxxxxxxx

2x) xxxxxxxx xxxxx xxxxx xxxxxx xxxxxxxxxx X xx formuli xxx xxxxxxx:

Xxxxx xxxxx xxxxxxxx:

Xxxxxxxxx tegiminis xxxxxxxxxxx X - 20 xxxxxxxxxx

2x) xxxxxxxx látka xxxxx vzteklině

2c) očkovací xxxxx xxxxx xxxxxx xxxxxxxxxx X ve xxxxxxx pro xxxxxxx:

Xxxxx xxxxx xxxxxxxx:

Xxxxxxxxx X xxxxx inactivatum

2d) očkovací xxxxx proti spalničkám, xxxxxxxxxx x zarděnkám:

1 xxxxx xxxxxxxxxxxxxxx xxxxxxx (0,5 xx) obsahuje:

Morbillorum xxxxx xxxxxxxxxx¹ (Schwarz) xxx. 10^3,0 xxxxxxxx xxxxx xxx xxxxxxxx xxxxxxx₅₀³

Xxxxxxxxxxx xxxxx xxxxxxxxxx¹ (XXX 4385) xxx. 10^3,7 xxxxxxxx xxxxx xxx xxxxxxxx kulturu₅₀³

Rubeolae xxxxx xxxxxxxxxx² (Xxxxxx XX 27/3) min. 10^3,0 xxxxxxxx dávka xxx xxxxxxxx xxxxxxx₅₀³

¹ xxxxxxxxx na xxxxxxx xxxxxxxx embryí

² pomnoženo xx lidských diploidních xxxxxxx (XXX-5)

³ 50% xxxxxxxx xxxxx xxxxxxx xxxxxxx

XXXX

2xx) očkovací látka xxxxx spalničkám, příušnicím x xxxxxxxxx

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

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

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

Xxxxx xxxxxxxx² xxxxx xxxxxxxxxx (kmen Xxxxxx RA 27/3) xx xxxx xxx 1x10³ CCID₅₀*

* 50% xxxxxxxx xxxxx xxxxxxx xxxxxxx

¹ vyrobeno xx xxxxxxx kuřecích xxxxxx

² xxxxxxxx na lidských xxxxxxxxxxx buňkách XX-38 xxxxxxxxxxxxx.

3. Xxxxxxxxx xxxxxxx xxxxxxxxxx xxxxx pro xxxxxxxxx xxxxxxxx

3x) xxxxxxxx xxxxx proti xxxxxx xxxxxxxxxx X xx xxxxxxx pro xxxxxxx:

Xxxxx xxxxxxxxx X xxxxxxxxxxx

3x) xxxxxxxx xxxxx proti xxxxxx xxxxxxxxxx A xx xxxxxxx xxx xxxx:

Xxxxx xxxxxxxxx A xxxxxxxxxxx

3x) očkovací xxxxx xxxxx xxxxxxxxxx, příušnicím x zarděnkám:

1 dávka xxxxxxxxxxxxxxx xxxxxxx (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx virus xxxxxxxxxx¹ (Xxxxxxx) xxx. 10^3,0 xxxxxxxx xxxxx xxx buněčnou kulturu₅₀³

Parotitidis xxxxx xxxxxxxxxx¹ (XXX 4385) xxx. 10^3,7 xxxxxxxx xxxxx pro xxxxxxxx kulturu₅₀³

Rubeolae xxxxx xxxxxxxxxx² (Xxxxxx XX 27/3) xxx. 10^3,0 xxxxxxxx dávka pro xxxxxxxx xxxxxxx₅₀³

¹ xxxxxxxxx xx xxxxxxx xxxxxxxx xxxxxx

² pomnoženo xx xxxxxxxx xxxxxxxxxxx xxxxxxx (XXX-5)

³ 50% infekční xxxxx xxxxxxx xxxxxxx

XXXX

3xx) xxxxxxxx látka xxxxx xxxxxxxxxx, příušnicím x xxxxxxxxx

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

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

Xxxxx xxxxxxxxxxx¹ vivum attenuatum (xxxx Jeryl Xxxx™, xxxxxxx B) xx xxxx než 12,5x10³ XXXX₅₀*

Xxxxx xxxxxxxx² xxxxx xxxxxxxxxx (kmen Xxxxxx XX 27/3) ne xxxx xxx 1x110³ XXXX₅₀*

* 50% xxxxxxxx xxxxx xxxxxxx xxxxxxx

¹ xxxxxxxx xx xxxxxxx xxxxxxxx xxxxxx

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

Xxxxxxx:

xxxx. XXXx. Xxxxx, XXx., XXX, XXXX, x. x.

Informace

Právní předpis x. 375/2024 Xx. xxxxx xxxxxxxxx dnem 10.12.2024.

Xx xxx xxxxxxxx nebyl xxxxx či xxxxxxxxx.

Xxxxx xxxxxxxxxxxx xxxxxxxx norem xxxxxx xxxxxxxx xxxxxxxx x xxxxxxxx xxxx xxxxxxxxxxxxx, pokud xx xxxx xxxxxx xxxxxxxxx xxxxx shora xxxxxxxxx xxxxxxxx xxxxxxxx.