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

XXXXXXX

Xxxxxxxxxxxx xxxxxxxxxxxxx

xx dne 5. prosince 2024

o xxxxxxxxxx složení očkovacích xxxxx xxx xxxxxxxxxx, xxxxxxxx x xxxxxxxxx xxxxxxxx xxx rok 2025
&xxxx;

Xxxxxxxxxxxx xxxxxxxxxxxxx podle §80 xxxx. 1 xxxx. e) xxxxxx x. 258/2000 Sb., x xxxxxxx xxxxxxxxx xxxxxx a o xxxxx xxxxxxxxx souvisejících xxxxxx, ve xxxxx xxxxxxxxxx xxxxxxxx, xxxxxxx xx xxxxxxx xxxxxxxxxx Xxxxxxx xxxxxxxxxx xxxxxx xxxxxxxxx xxxxxxx xxxxxxxxxx xxxxx pro pravidelná, xxxxxxxx x xxxxxxxxx xxxxxxxx xxx xxx 2025:

1. Xxxxxxxxx xxxxxxx xxxxxxxxxx xxxxx xxx xxxxxxxxxx xxxxxxxx

1x) xxxxxxxxxxx xxxxxxxx xxxxx xxxxx xxxxxxx, dávivému kašli (xxxxxxxxxx forma), xxxxxx, xxxxxx xxxxxxxx xxxxx (xxxxxxxxxxxx forma), xxxxxx xxxxxxxxxx B, xxxxxxx xxxxxxxxx Haemophilus influenzae xxx x (DTaPHibVHBIPV)

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

Xxxxxxxxxxx xxxxxxxxxx¹ ne méně xxx 30 mezinárodních xxxxxxxx (IU)

Tetani xxxxxxxxxx1 xx méně xxx 40 xxxxxxxxxxxxx jednotek (XX)

Xxxxxxxx Xxxxxxxxxx pertussis:

Pertussis xxxxxxxxxx (XX)¹ 25 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxxxx xxxxxxxxxxxx (XXX)¹ 25 mikrogramů

Pertactinum (XXX)¹ 8 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx B (XXx)^2,3 10 mikrogramů

Virus xxxxxxxxxxxxxxx xxxxxxxxxxx (IPV)

ty xxx 1 (xxxx Xxxxxxx)⁴ 40 D xxxxxxxx xxxxxxxx

xxxxx 2 (xxxx MEF-1)⁴ 8 X xxxxxxxx antigenu

typus 3 (xxxx Saukett)⁴ 32 D xxxxxxxx xxxxxxxx

Xxxxxxxxxxx xxxxxxxxxx xxxxx x xxxxxxxxxxxxxxx

(Xxxxxxxxxxxxxxxxxxx xxxxxxxx) 10 xxxxxxxxxx

xxxx. xxx xxxxxx. tetanico jako xxxxx xxxxxxx přibližně 25 mikrogramů

¹ xxxxxxxxxxx xx hydroxid xxxxxxx, xxxxxxxxxxx (Xx(XX)₃) 0,5 xxxxxxxxx Al³⁺

² vyrobeno xxxxxxxxxxxxx DNA technologií xx xxxxxxx xxxxxxxxxxxx xxxxx (Saccharomyces xxxxxxxxxx)

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

⁴ pomnoženo xx XXXX xxxxxxx

XXXX

1xx) xxxxxxxxxxx očkovací xxxxx xxxxx záškrtu, dávivému xxxxx (acelulární xxxxx), xxxxxx, xxxxxx xxxxxxxx xxxxx (xxxxxxxxxxxx forma), xxxxxx xxxxxxxxxx B, xxxxxxx xxxxxxxxx Xxxxxxxxxxx xxxxxxxxxx typ x (XXxXXxxXXXXXX)

Xxxxx xxxxx¹ (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx anatoxinum xx xxxx xxx 20 mezinárodních xxxxxxxx (XX)^2,4 (30 Xx)

Xxxxxx xxxxxxxxxx xx méně xxx 40 mezinárodních 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 (MEF-1) 7 X jednotek xxxxxxxx⁶

xxxxx 3 (Xxxxxxx) 26 X jednotek xxxxxxxx⁶

Xxxxxxxxx xxxxxxxxxxx X antigenum⁷ 10 mikrogramů

Haemophili xxxxxxxxxx xxxx B polysaccharidum (Xxxxxxxxxxxxxxxxxxx xxxxxxxx) 12 xxxxxxxxxx xxxxxxxxxx xxx xxxxxx xxxxxxxx 22-36 xxxxxxxxxx

¹ Adsorbováno na xxxxxxxxxxx hydroxid hlinitý (0,6 xx Xx³⁺)

² Xxxx xxxxxx mez xxxxxxxxxxxxx (p = 0,95) a ne xxxx xxx 30 XX jako xxxxxxx xxxxxxx

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

⁴ Xxxx xxxxxxxxxxxx aktivita stanovená xxxxxxxxxx imunogenity

⁵ Xxxxxxxxxxx xx Xxxx buňkách

⁶ Xxxx xxxxxxxx antigenu xxxx xxxxx xxxxxx xxxx xx, xxxxx xxxx xxxxx vyjádřená xxxx 40-8-32 X xxxxxxxx antigenu xxx xxxxx typu 1, 2 x 3, xxx měření xxxxx xxxxxxx xxxxxxxxxxxxxx xxxxxxx

⁷ xxxxxxxx rekombinantní XXX xxxxxxxxxxx x kvasinkových xxxxxxx Xxxxxxxxx xxxxxxxxxx

XXXX

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

Xxxxx xxxxx (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx xxxxxxxxxx1 xx xxxx xxx 20 XX⁶

Xxxxxx xxxxxxxxxx1 ne xxxx xxx 40 XX⁶

Xxxxxxxx Xxxxxxxxxxx pertusis¹

Pertussis xxxxxxxxxx (XX) 20 xxxxxxxxxx

Xxxxxxxxxxxxxxx xxxxxxxxxxxx (XXX) 20 xxxxxxxxxx

Xxxxxxxxxxx (XXX) 3 xxxxxxxxxx

Xxxxxxxx xxxx 2 xx 3 (XXX) 5 mikrogramů

Antigenum xxxxxxxxx xxxxxxxxxxx X ^2,3 10 xxxxxxxxxx

Xxxxx poliomyelitidis (xxxxxxxxxxx)⁴

Xxxxx 1 (Mahoney) 40 X jednotek xxxxxxxx⁵

Xxxxx 2 (XXX-1) 8 X xxxxxxxx xxxxxxxx⁵

Xxxxx 3 (Saukett) 32 X jednotek xxxxxxxx⁵

Xxxxxxxxxxxxxx Xxxxxxxxxx influenzae xxxxx x

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

¹ adsorbováno xx xxxxxxxxxxx xxxxxxx (0,17 xx Xx³⁺)

² xxxxxxxxxxx xx xxxxxxxxxxx hydroxid xxxxxxx sulfát (0,15 xx Xx³⁺)

³ xxxxxxxx xxxxxxxxxxxxx XXX technologií x xxxxxxxxxxxx xxxxxxx Xxxxxxxxxxxxx cerevisiae

⁴ xxxxxxxxx xx Xxxx buňkách

⁵ xxxx xxxxxxxxxxxx množství xxxxxxxx xxxxxxxxx vhodnou xxxxxxxxxxxxxx xxxxxxx

⁶ xxxx xxxxxxxxxxxx aktivita xxxxxxxxx xxxxxxxxxxxx imunogenity

1b) xxxxxxxx xxxxx proti záškrtu, xxxxxxxx kašli (xxxxxxxxxx xxxxx), xxxxxx (DTaP)

Jedna xxxxx (0,5 xx) xxxxxxxx xxxx léčivé xxxxx:

Xxxxxxxxxxx anatoxinum* ≥ 30 IU

Tetani anatoxinum* ≥ 40 XX

Xxxxxxxxx xxxxxxxxxx* (PT) 25 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxxx filamentosum* (XXX) 25 xxxxxxxxxx

Xxxxxxxxxxx* (69xX) 8 xxxxxxxxxx

* xxxxxxxxxxx xx xxxxxxxx xxxxxxx xxxxxx: 0,5 xxxxxxxxx

XXXX

1xx) Xxxxxxxx xxxxx xxxxx záškrtu, xxxxxx x dávivému kašli (xxxxxxxxxx) se sníženým xxxxxxx antigenů (Tdap)

Jedna xxxxx (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx xxxxxxxxxx - Xxxxxxxxx 2 XX* (2 Lf)

Tetani xxxxxxxxxx - Minimálně 20 XX* (5 Xx)

Xxxxxxxxx xxxxxxxx

Xxxxxxxxx anatoxinum - 2,5 xxxxxxxxxx

Xxxxxxxxxxxxxx filamentosum - 5 mikrogramů

Pertactinum - 3 xxxxxxxxxx

Xxxxxxxx, xxxx 2 xx 3 - 5 xxxxxxxxxx

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

* Jako spodní xxxxxxx xxxxxxxxx xxxxxxxxxxxxx (x = 0,95) xxxxxxxx xxxxxx xxxxx xxxxx xxxxxxxxx v Xxxxxxxxx xxxxxxxx

XXXX

1xx) Xxxxxxxx xxxxx xxxxx záškrtu, xxxxxx a xxxxxxxx xxxxx (xxxxxxxxxx xxxxxxxxxx) xx xxxxxxxx obsahem xxxxxxxx (Xxxx)

Xxxxx dávka (0,5 xx) xxxxxxxx:

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

Xxxxxx xxxxxxxxxx¹ xx xxxx xxx 20 xxxxxxxxxxxxx jednotek (IU) (5 Lf)

Bordetellae xxxxxxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxxx¹ 8 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxx filamentosum¹ 8 xxxxxxxxxx

Xxxxxxxxxxx¹ 2,5 xxxxxxxxxx

¹ xxxxxxxxxxx xx xxxxxxxxxxx xxxxxxxx xxxxxxx (X1(XX)₃) 0,3 xxxxxxxxx Xx³⁺ x xxxxxxxxxxx xxxxxxx (XxXX₄) 0,2 xxxxxxxxx Al³⁺

1c) xxxxxxxx xxxxx proti xxxxxxx xxxxxxxxx Xxxxxxxxxxx influenzae xxx x:

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

Xxxxxxxxxxx xxxxxxxxxx xxxxx x xxxx xxxxxxxxxxx 10 xxxxxxxxxx

xxxxxxxxxxx x xxxxxxxxxx toxoidem xxxx xxxxxxxxxxx nosičem xxxxxxxxx 25 mikrogramů

1d) xxxxxxxx xxxxx xxxxx xxxxxx:

Xxxxx dávka xxxxxxxx:

Xxxxxx xxxxxxxxxx - min. 40 mezinárodních xxxxxxxx

1x) xxxxxxxx látka proti xxxxxx xxxxxxxxxx X x xxxxxx formuli:

Jedna xxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx B - 10 xxxxxxxxxx

1x) očkovací xxxxx proti xxxxxx xxxxxxxxxx B x xxxxxxx xxxxxxx

Xxxxx xxxxx xxxxxxxx:

Xxxxxxxxx tegiminis xxxxxxxxxxx X - 20 xxxxxxxxxx

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

xxxxx xxxxxxxxxxxxxxx xxxxxxx (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx virus attenuatum¹ (Xxxxxxx) xxx. 10^3,0 xxxxxxxx xxxxx xxx xxxxxxxx xxxxxxx₅₀³

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

Xxxxxxxx xxxxx xxxxxxxxxx² (Xxxxxx RA 27/3) xxx. 10^3,0 xxxxxxxx xxxxx pro buněčnou xxxxxxx₅₀³

¹ pomnoženo xx xxxxxxx xxxxxxxx xxxxxx

² xxxxxxxxx na lidských xxxxxxxxxxx xxxxxxx (MRC-5)

³ 50% infekční xxxxx xxxxxxx kultury

NEBO

1ga) očkovací xxxxx xxxxx xxxxxxxxxx, xxxxxxxxxx a zarděnkám

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

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

Xxxxx parotitidis¹ xxxxx attenuatum (kmen Xxxxx Xxxx™, xxxxxxx X) xx méně xxx 12,5x10³ XXXX₅₀*

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

* 50% infekční dávka xxxxxxx xxxxxxx

¹ xxxxxxxx xx xxxxxxx kuřecích xxxxxx.

² xxxxxxxx xx xxxxxxxx diploidních xxxxxxxx XX-38 xxxxxxxxxxxxx

1x) očkovací xxxxx proti xxxxxx xxxxxxxx xxxxx x xxxxxxxxxxxx xxxxx:

Xxxxx xxxxx (0,5 xx) xxxxxxxx:

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

Xxxxx poliomyelitis xxxxxxxxxxx xxxxx 2 (XXX-1) ... 7 antigenních X xxxxxxxx**

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

* Xxxxxxxxxxx xx XXXX xxxxxxx

** Xxxx xxxxxxxx xxxxxxxx jsou xxxxx xxxxxx xxxx xx, která xxxx xxxxx xxxxxxxxx xxxx 40-8-32 D xxxxxxxx xxxxxxxx xxx virus xxxx 1, 2 x 3, při xxxxxx xxxxx vhodnou xxxxxxxxxxxxxx xxxxxxx

1xx) xxxxxxxxxxx xxxxxxxx xxxxx proti xxxxxxxxxxxxx xxxxxxxx

Xxxxx xxxxx (0,5 ml) xxxxxxxx:

Xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Streptococcus xxxxxxxxxx sérotypu 1 ^1,2 2,2 µg

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

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

polysacharid xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx sérotypu 5 ^1,2 2,2 µg

polysacharid xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 6X ^1,2 2,2 µx

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

polysacharid xxxxxxxx (xxxxxxxxxx) Streptococcus xxxxxxxxxx xxxxxxxx 7F ^1,2 2,2 µg

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

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

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

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

xxxxxxxxxxxx bakterie (pneumokoka) Xxxxxxxxxxxxx pneumoniae sérotypu 12X ^1,2 2,2 µx

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

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

xxxxxxxxxxxx bakterie (pneumokoka) Xxxxxxxxxxxxx xxxxxxxxxx sérotypu 18X ^1,2 2,2 µx

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

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

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

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

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

1 Konjugován s xxxxxx proteinem CRM₁₉₇ (xxxxxxxxx 51 µg xx xxxxx)

2 Xxxxxxxxxx xx xxxxxxxxxxx xxxxxxx (0,125 xx hliníku xx dávku)

NEBO

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

1xxxx) konjugovaná xxxxxxxx xxxxx obsahuje:

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

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

Streptococci xxxxxxxxxx serotypi 4^1,2 xxxxxxxxxxxxxxx 2,0 mikrogramů

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

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

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

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 7F^1,2 xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx

Xxxxxxxxxxxx xxxxxxxxxx serotypi 9X^1,2 xxxxxxxxxxxxxxx 2,0 mikrogramů

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

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

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 19A^1,2 xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx

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

Xxxxxxxxxxxx xxxxxxxxxx serotypi 22X^1,2 xxxxxxxxxxxxxxx 2,0 mikrogramů

Streptococci 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 netoxická mutace xxxxxxxxxxxx xxxxxx (xxxxxxxxxxxxx x Xxxxxxxxxxxxxxx xxxxxxxxxxx X7) xxxxxxxxxxxxx exprimováného x Xxxxxxxxxxx xxxxxxxxxxx

² Xxxxxxxxxx xx xxxxxxxx xxxxxxxxxxx xxxxxxx

X

1xxxx) xxxx xxxxxxxxxxx xxxxxxxx xxxxx xxxxxxxx:

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

XXXX

1xxx) xxxxxxxx xxxxx xxxxx xxxxxxxxxxxxx infekcím xxxxxxxxx x xxxxxxxxxx xxxxxxxx:

1xxxx) xxxxxxxxxxx xxxxxxxx xxxxx xxxxxxxx:

Xxxxxxxxxxxx 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 pneumoniae polysaccharidum xxxxxxxxx 6X¹ 4,4 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 7X¹ 2,2 µx

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 9V¹ 2,2 µx

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 14¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 18X¹ 2,2 µx

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 19A¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum xxxxxxxxx 19F¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum xxxxxxxxx 23X¹ 2,2 µx

¹ Xxxxxxxxxx x xxxxxx xxxxxxxxx CRM₁₉₇ x xxxxxxxxxx na xxxxxxxxxxx xxxxxxx (0,125 xx xxxxxxx)

X

1xxxx) póly xxxxxxxxxxx očkovací látka xxxxxxxx:

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

1x) xxxxxxxx xxxxx xxxxx záškrtu, xxxxxxxx xxxxx (xxxxxxxxxx forma), xxxxxx, xxxxxx xxxxxxxx xxxxx (xxxxxxxxxxxx xxxxx):

Xxxxx xxxxx (0,5 ml) xxxxxxxx:

Xxxxxxxxxxx xxxxxxxxxx¹ - xx xxxx xxx 2 mezinárodní xxxxxxxx (XX) (2,5 Xx)

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

Xxxxxxxxxxx xxxxxxxxx antigena:

Pertussis xxxxxxxxxx¹ - 8 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxx xxxxxxxxxxxx¹ - 8 xxxxxxxxxx

Xxxxxxxxx1 2,5 mikrogramů

Virus xxxxxxxxxxxxxxx xxxxxxxxxxx:

xxxxx 1 (kmen Xxxxxxx)² 40 X xxxxxxxx xxxxxxxx

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

typus 3 (kmen Xxxxxxx)² 32 D xxxxxxxx xxxxxxxx

¹ xxxxxxxxxxx na xxxxxxxxxxx xxxxxxxx xxxxxxx (Xx(XX)₃) 0,3 xxxxxxxxx Xx³⁺ x xxxxxxxxxxx xxxxxxx (AlPO₄) 0,2 xxxxxxxxx Xx³⁺

² xxxxxxxxx xx VERO xxxxxxx

XXXX

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

Xxxxx xxxxx (0,5 ml) xxxxxxxx:

Xxxxxxxxxxx xxxxxxxxxx xxxxxxxxx 2 XX¹ (2 Xx)

Xxxxxx xxxxxxxxxx xxxxxxxxx 20 XX¹ (5 Xx)

Xxxxxxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxxx 2,5 xxxxxxxxxx

Xxxxxxxxx haemagglutininum xxxxxxxxxxxx 5 xxxxxxxxxx

Xxxxxxxxxxx 3 xxxxxxxxxx

Xxxxxxxx, xxxx 2 xx 3 5 xxxxxxxxxx

Xxxxx xxxxxxxxxxxxxxx (xxxxxxxxxxx)²

xxxxx 1 (Mahoney) 29 X jednotek xxxxxxxx³

xxxxx 2 (XXX1) 7 X xxxxxxxx xxxxxxxx³

xxxxx 3 (Xxxxxxx) 26 X xxxxxxxx xxxxxxxx³

Xxxxxxxxxxx xx xxxxxxxxxxx hlinitý 1,5 xx (0,33 xx Xx³⁺)

¹ Xxxx xxxxxx xxxxxxx intervalu xxxxxxxxxxxxx (p = 0,95) xxxxxxxx xxxxxx xxxxx xxxxx popsaného x Xxxxxxxxx xxxxxxxx

² Xxxxxxxxxxx na Vero xxxxxxx

³ Tato množství xxxxxxxx jsou xxxxx xxxxxx xxxx ta, xxxxx xxxx dříve xxxxxxxxx xxxx 40-8-32 X xxxxxxxx xxxxxxxx xxx xxxxx xxxx 1, 2 a 3, xxx xxxxxx xxxxx xxxxxxx xxxxxxxxxxxxxx xxxxxxx

* Jako xxxxxx xxxxxxx xxxxxxxxx spolehlivosti (x = 0,95) xxxxxxxx xxxxxx xxxxx xxxxx xxxxxxxxx x Xxxxxxxxx xxxxxxxx

** Xxxxxxxxxxx xx Vero buňkách.

1j) xxxxxxxx látka xxxxx xxxxxxxxxxx (XXX xxxxxxx)

1x) xxxxxxxx látka xxxxx xxxxxx hepatitidě B xxx xxxxx xxxxxxxx xx dialyzačního xxxxxxxx:

Xxxxx xxxxx (0,5 xx) xxxxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx B^1,2,3 - 20 xxxxxxxxxx

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

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

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

2. Xxxxxxxxx xxxxxxx xxxxxxxxxx xxxxx pro xxxxxxxx xxxxxxxx

2x) xxxxxxxx látka xxxxx xxxxxx hepatitidě X xx xxxxxxx xxx xxxxxxx:

Xxxxx xxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx X - 20 xxxxxxxxxx

2x) xxxxxxxx xxxxx xxxxx xxxxxxxxx

2x) očkovací xxxxx proti xxxxxx xxxxxxxxxx X xx xxxxxxx pro xxxxxxx:

Xxxxx xxxxx xxxxxxxx:

Xxxxxxxxx X xxxxx xxxxxxxxxxx

2x) očkovací xxxxx proti xxxxxxxxxx, xxxxxxxxxx x xxxxxxxxx:

1 xxxxx xxxxxxxxxxxxxxx xxxxxxx (0,5 ml) xxxxxxxx:

Xxxxxxxxxxx xxxxx attenuatum¹ (Schwarz) xxx. 10^3,0 infekční xxxxx xxx buněčnou xxxxxxx₅₀³

Xxxxxxxxxxx xxxxx attenuatum¹ (XXX 4385) xxx. 10^3,7 xxxxxxxx xxxxx xxx xxxxxxxx xxxxxxx₅₀³

Xxxxxxxx xxxxx xxxxxxxxxx² (Xxxxxx XX 27/3) xxx. 10^3,0 infekční xxxxx xxx xxxxxxxx xxxxxxx₅₀³

¹ xxxxxxxxx xx xxxxxxx xxxxxxxx xxxxxx

² pomnoženo xx lidských xxxxxxxxxxx xxxxxxx (XXX-5)

³ 50% xxxxxxxx xxxxx xxxxxxx xxxxxxx

XXXX

2xx) xxxxxxxx látka xxxxx xxxxxxxxxx, xxxxxxxxxx x zarděnkám

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

Xxxxx morbillorum¹ xxxxx xxxxxxxxxx (xxxx Xxxxxx’ Xxxxxxxxx) xx xxxx než 1x10³ XXXX₅₀*

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

Xxxxx xxxxxxxx² xxxxx xxxxxxxxxx (xxxx Xxxxxx XX 27/3) xx xxxx než 1x10³ CCID₅₀*

* 50% xxxxxxxx xxxxx xxxxxxx xxxxxxx

¹ vyrobeno xx xxxxxxx xxxxxxxx xxxxxx

² xxxxxxxx xx lidských xxxxxxxxxxx buňkách WI-38 xxxxxxxxxxxxx.

3. Xxxxxxxxx složení xxxxxxxxxx látek xxx xxxxxxxxx xxxxxxxx

3x) xxxxxxxx xxxxx xxxxx xxxxxx xxxxxxxxxx A xx xxxxxxx pro dospělé:

Virus xxxxxxxxx X inactivatum

3b) xxxxxxxx xxxxx xxxxx xxxxxx xxxxxxxxxx X xx formuli xxx xxxx:

Xxxxx xxxxxxxxx X xxxxxxxxxxx

3x) xxxxxxxx látka xxxxx xxxxxxxxxx, příušnicím x xxxxxxxxx:

1 xxxxx xxxxxxxxxxxxxxx vakcíny (0,5 xx) xxxxxxxx:

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

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

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

¹ xxxxxxxxx xx xxxxxxx xxxxxxxx xxxxxx

² xxxxxxxxx xx xxxxxxxx xxxxxxxxxxx xxxxxxx (XXX-5)

³ 50% xxxxxxxx xxxxx xxxxxxx xxxxxxx

XXXX

3xx) xxxxxxxx xxxxx xxxxx xxxxxxxxxx, xxxxxxxxxx a xxxxxxxxx

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

Xxxxx morbillorum¹ xxxxx xxxxxxxxxx (xxxx Enders’ Xxxxxxxxx) ne xxxx xxx 1x10³ CCID₅₀*

Virus xxxxxxxxxxx¹ vivum xxxxxxxxxx (xxxx Jeryl Xxxx™, xxxxxxx X) ne xxxx xxx 12,5x10³ XXXX₅₀*

Xxxxx xxxxxxxx² vivum xxxxxxxxxx (xxxx Wistar XX 27/3) xx xxxx xxx 1x110³ XXXX₅₀*

* 50% xxxxxxxx xxxxx xxxxxxx xxxxxxx

¹ xxxxxxxx na buňkách xxxxxxxx embryí

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

Xxxxxxx:

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

Xxxxxxxxx

Xxxxxx předpis č. 375/2024 Sb. xxxxx xxxxxxxxx xxxx 10.12.2024.

Xx xxx uzávěrky xxxxx xxxxx či xxxxxxxxx.

Xxxxx xxxxxxxxxxxx xxxxxxxx xxxxx xxxxxx právních xxxxxxxx x odkazech xxxx xxxxxxxxxxxxx, pokud se xxxx xxxxxx xxxxxxxxx xxxxx shora xxxxxxxxx xxxxxxxx předpisu.