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

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

Xxxxxxxxxxxx zdravotnictví podle §80 odst. 1 xxxx. e) zákona x. 258/2000 Sb., x xxxxxxx xxxxxxxxx xxxxxx a o xxxxx xxxxxxxxx xxxxxxxxxxxxx xxxxxx, xx znění xxxxxxxxxx předpisů, xxxxxxx xx xxxxxxx xxxxxxxxxx Xxxxxxx xxxxxxxxxx xxxxxx xxxxxxxxx xxxxxxx očkovacích xxxxx xxx xxxxxxxxxx, xxxxxxxx x mimořádná xxxxxxxx xxx xxx 2025:

1. Xxxxxxxxx xxxxxxx xxxxxxxxxx látek xxx xxxxxxxxxx očkování

1a) kombinovaná xxxxxxxx látka proti xxxxxxx, xxxxxxxx xxxxx (xxxxxxxxxx forma), xxxxxx, xxxxxx xxxxxxxx obrně (xxxxxxxxxxxx forma), xxxxxx xxxxxxxxxx X, nákazám xxxxxxxxx Xxxxxxxxxxx xxxxxxxxxx xxx x (XXxXXxxXXXXXX)

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

Diphtheriae xxxxxxxxxx¹ xx xxxx xxx 30 mezinárodních xxxxxxxx (XX)

Xxxxxx xxxxxxxxxx1 xx xxxx než 40 mezinárodních jednotek (XX)

Xxxxxxxx Xxxxxxxxxx xxxxxxxxx:

Xxxxxxxxx xxxxxxxxxx (XX)¹ 25 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxxxx filamentosum (XXX)¹ 25 mikrogramů

Pertactinum (XXX)¹ 8 xxxxxxxxxx

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

Xxxxx xxxxxxxxxxxxxxx xxxxxxxxxxx (XXX)

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

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

xxxxx 3 (xxxx Saukett)⁴ 32 X xxxxxxxx xxxxxxxx

Xxxxxxxxxxx influenzae xxxxx x polysaccharidum

(Polyribosylribitoli xxxxxxxx) 10 mikrogramů

conj. xxx xxxxxx. xxxxxxxx jako xxxxx xxxxxxx přibližně 25 xxxxxxxxxx

¹ xxxxxxxxxxx xx xxxxxxxx xxxxxxx, xxxxxxxxxxx (Al(OH)₃) 0,5 xxxxxxxxx Xx³⁺

² xxxxxxxx xxxxxxxxxxxxx XXX technologií xx xxxxxxx kvasinkových xxxxx (Saccharomyces cerevisiae)

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

⁴ pomnoženo xx VERO buňkách

NEBO

1aa) xxxxxxxxxxx xxxxxxxx xxxxx xxxxx xxxxxxx, dávivému xxxxx (xxxxxxxxxx forma), xxxxxx, xxxxxx xxxxxxxx xxxxx (xxxxxxxxxxxx xxxxx), xxxxxx xxxxxxxxxx B, xxxxxxx xxxxxxxxx Xxxxxxxxxxx xxxxxxxxxx typ x (XXxXXxxXXXXXX)

Xxxxx xxxxx¹ (0,5 xx) xxxxxxxx:

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

Xxxxxx xxxxxxxxxx ne méně xxx 40 mezinárodních xxxxxxxx (XX)^3,4 (10 Xx)

Xxxxxxxx Bordetelly xxxxxxxxx

Xxxxxxxxx xxxxxxxxxx 25 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxxxx filamentosum 25 xxxxxxxxxx

Xxxxx Xxxxxxxxxxxxxxx (inaktivovaný)⁵

typus 1 (Xxxxxxx) 29 X jednotek antigenu⁶

typus 2 (XXX-1) 7 X xxxxxxxx xxxxxxxx⁶

xxxxx 3 (Saukett) 26 X xxxxxxxx xxxxxxxx⁶

Xxxxxxxxx xxxxxxxxxxx B antigenum⁷ 10 mikrogramů

Haemophili influenzae xxxx X polysaccharidum (Xxxxxxxxxxxxxxxxxxx xxxxxxxx) 12 xxxxxxxxxx xxxxxxxxxx xxx xxxxxx proteino 22-36 xxxxxxxxxx

¹ Xxxxxxxxxxx xx xxxxxxxxxxx hydroxid hlinitý (0,6 xx Al³⁺)

² Xxxx spodní xxx xxxxxxxxxxxxx (x = 0,95) a ne xxxx než 30 XX jako xxxxxxx xxxxxxx

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

⁴ Xxxx xxxxxxxxxxxx aktivita stanovená xxxxxxxxxx xxxxxxxxxxx

⁵ Xxxxxxxxxxx xx Xxxx xxxxxxx

⁶ Xxxx xxxxxxxx xxxxxxxx xxxx úplně xxxxxx xxxx xx, xxxxx xxxx dříve vyjádřená xxxx 40-8-32 X xxxxxxxx xxxxxxxx xxx xxxxx typu 1, 2 a 3, xxx xxxxxx xxxxx xxxxxxx xxxxxxxxxxxxxx metodou

⁷ xxxxxxxx xxxxxxxxxxxxx DNA xxxxxxxxxxx v kvasinkových xxxxxxx Xxxxxxxxx xxxxxxxxxx

XXXX

1xx) Xxxxxxx proti xxxxxxx, xxxxxx, xxxxxxxx kašli (xxxxxxxxxx xxxxxxxxxx), xxxxxxxxxx X (rDNA), xxxxxx xxxxxxxx xxxxx (xxxxxxxxxxxx) x konjugovaná vakcína xxxxx Haemophilus xxxx x (adsorbovaná)

Jedna xxxxx (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx xxxxxxxxxx1 xx xxxx xxx 20 XX⁶

Xxxxxx xxxxxxxxxx1 xx méně xxx 40 IU⁶

Antigena Xxxxxxxxxxx pertusis¹

Pertussis anatoxinum (XX) 20 mikrogramů

Haemagglutinium xxxxxxxxxxxx (XXX) 20 xxxxxxxxxx

Xxxxxxxxxxx (PRN) 3 xxxxxxxxxx

Xxxxxxxx xxxx 2 xx 3 (FIM) 5 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx X ^2,3 10 mikrogramů

Virus xxxxxxxxxxxxxxx (xxxxxxxxxxx)⁴

Xxxxx 1 (Xxxxxxx) 40 D jednotek xxxxxxxx⁵

Xxxxx 2 (MEF-1) 8 X xxxxxxxx xxxxxxxx⁵

Xxxxx 3 (Xxxxxxx) 32 X xxxxxxxx xxxxxxxx⁵

Xxxxxxxxxxxxxx Xxxxxxxxxx influenzae xxxxx x

(Xxxxxxxxxxxxxxxxxxx xxxxxxxx) 3 xxxxxxxxxx conjunctum xxx proteinům meningococci xxxxx x² 50 xxxxxxxxxx

¹ xxxxxxxxxxx na xxxxxxxxxxx hlinitý (0,17 xx Xx³⁺)

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

³ vyrobeno xxxxxxxxxxxxx XXX technologií x kvasinkových xxxxxxx Xxxxxxxxxxxxx xxxxxxxxxx

⁴ xxxxxxxxx xx Xxxx xxxxxxx

⁵ xxxx xxxxxxxxxxxx xxxxxxxx xxxxxxxx stanovené xxxxxxx xxxxxxxxxxxxxx xxxxxxx

⁶ nebo xxxxxxxxxxxx xxxxxxxx xxxxxxxxx xxxxxxxxxxxx imunogenity

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

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

Xxxxxxxxxxx xxxxxxxxxx* ≥ 30 XX

Xxxxxx anatoxinum* ≥ 40 IU

Pertussis xxxxxxxxxx* (XX) 25 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxxxxx* (XXX) 25 xxxxxxxxxx

Xxxxxxxxxxx* (69xX) 8 mikrogramů

* xxxxxxxxxxx xx hydroxid xxxxxxx celkem: 0,5 xxxxxxxxx

XXXX

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

Xxxxx xxxxx (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx xxxxxxxxxx - Xxxxxxxxx 2 XX* (2 Lf)

Tetani xxxxxxxxxx - Xxxxxxxxx 20 XX* (5 Xx)

Xxxxxxxxx xxxxxxxx

Xxxxxxxxx anatoxinum - 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 xxxxxx xxxxxxx intervalu xxxxxxxxxxxxx (x = 0,95) xxxxxxxx xxxxxx xxxxx xxxxx xxxxxxxxx x Xxxxxxxxx xxxxxxxx

XXXX

1xx) Očkovací xxxxx xxxxx xxxxxxx, xxxxxx a xxxxxxxx xxxxx (acelulární komponenta) xx sníženým obsahem xxxxxxxx (Tdap)

Jedna xxxxx (0,5 xx) obsahuje:

Diphtheriae xxxxxxxxxx¹ ne xxxx xxx 2 xxxxxxxxxxx xxxxxxxx (XX) (2,5 Xx)

Xxxxxx anatoxinum¹ ne xxxx xxx 20 xxxxxxxxxxxxx jednotek (IU) (5 Lf)

Bordetellae xxxxxxxxx xxxxxxxx:

Xxxxxxxxx anatoxinum¹ 8 xxxxxxxxxx

Xxxxxxxxx haemagglutinum xxxxxxxxxxxx¹ 8 xxxxxxxxxx

Xxxxxxxxxxx¹ 2,5 xxxxxxxxxx

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

1c) očkovací xxxxx xxxxx nákazám xxxxxxxxx Haemophilus xxxxxxxxxx xxx b:

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

Xxxxxxxxxxx influenzae xxxxx x póly xxxxxxxxxxx 10 xxxxxxxxxx

xxxxxxxxxxx x tetanickým toxoidem xxxx xxxxxxxxxxx nosičem xxxxxxxxx 25 mikrogramů

1d) xxxxxxxx xxxxx proti xxxxxx:

Xxxxx xxxxx obsahuje:

Tetani xxxxxxxxxx - xxx. 40 xxxxxxxxxxxxx xxxxxxxx

1x) xxxxxxxx xxxxx proti xxxxxx xxxxxxxxxx X x xxxxxx xxxxxxx:

Xxxxx xxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx X - 10 xxxxxxxxxx

1x) xxxxxxxx xxxxx xxxxx virové xxxxxxxxxx B x xxxxxxx xxxxxxx

Xxxxx xxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxx hepatitidis X - 20 xxxxxxxxxx

1x) xxxxxxxx xxxxx xxxxx xxxxxxxxxx, příušnicím x xxxxxxxxx:

xxxxx xxxxxxxxxxxxxxx xxxxxxx (0,5 xx) xxxxxxxx:

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

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

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

¹ xxxxxxxxx xx xxxxxxx xxxxxxxx xxxxxx

² xxxxxxxxx na xxxxxxxx xxxxxxxxxxx xxxxxxx (XXX-5)

³ 50% xxxxxxxx dávka xxxxxxx kultury

NEBO

1ga) xxxxxxxx xxxxx xxxxx spalničkám, xxxxxxxxxx x xxxxxxxxx

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

Xxxxx xxxxxxxxxxx¹ vivum attenuatum (xxxx Xxxxxx’ Edmonston) xx méně než 1x10³ XXXX₅₀*

Xxxxx xxxxxxxxxxx¹ xxxxx xxxxxxxxxx (xxxx Xxxxx Xxxx™, xxxxxxx X) ne xxxx 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 na xxxxxxxx xxxxxxxxxxx plicních XX-38 fibroblastech

1h) xxxxxxxx xxxxx xxxxx xxxxxx xxxxxxxx xxxxx x xxxxxxxxxxxx formě:

Jedna xxxxx (0,5 xx) xxxxxxxx:

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

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

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

* Kultivováno xx XXXX xxxxxxx

** Tato xxxxxxxx xxxxxxxx jsou xxxxx xxxxxx jako xx, xxxxx xxxx xxxxx xxxxxxxxx xxxx 40-8-32 X xxxxxxxx xxxxxxxx xxx virus xxxx 1, 2 x 3, při xxxxxx jinou vhodnou xxxxxxxxxxxxxx xxxxxxx

1xx) xxxxxxxxxxx xxxxxxxx xxxxx xxxxx xxxxxxxxxxxxx infekcím

Jedna xxxxx (0,5 xx) xxxxxxxx:

Xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 1 ^1,2 2,2 µg

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

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

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

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

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

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

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

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

xxxxxxxxxxxx bakterie (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx sérotypu 10X ^1,2 2,2 µx

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

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

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

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

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

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

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

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

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

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

1 Konjugován x xxxxxx xxxxxxxxx XXX₁₉₇ (xxxxxxxxx 51 µx xx xxxxx)

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

XXXX

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

1chaa) xxxxxxxxxxx xxxxxxxx xxxxx obsahuje:

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

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 3^1,2 xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 4^1,2 xxxxxxxxxxxxxxx 2,0 mikrogramů

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

Streptococci xxxxxxxxxx xxxxxxxx 6A^1,2 xxxxxxxxxxxxxxx 2,0 mikrogramů

Streptococci xxxxxxxxxx serotypi 6X^1,2 xxxxxxxxxxxxxxx 4,0 mikrogramů

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

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

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

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

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

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

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

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

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

¹ Xxxxxxxxxx x xxxxxxxxxxx xxxxxxx XXX₁₉₇, XXX₁₉₇ xx netoxická mutace xxxxxxxxxxxx xxxxxx (xxxxxxxxxxxxx x Corynebacterium diphtheriae X7) rekombinantně exprimováného x Pseudomonas xxxxxxxxxxx

² Xxxxxxxxxx xx adjuvans xxxxxxxxxxx xxxxxxx

X

1xxxx) póly xxxxxxxxxxx očkovací xxxxx xxxxxxxx:

xx 25 mikrogramech xxxxxxxxxxxxx 23 xxxxxxxxxxxxxx xxxxxxxxxxxxxxxxx sérotypů: 1, 2, 3, 4, 5, 6X, 7X, 8, 9X, 9X, 10X, 11A, 12X, 14, 15X, 17X, 18X, 19X, 19X, 20, 22F, 23X, 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 xxxxxxxxxx polysaccharidum xxxxxxxxx 3¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 4¹ 2,2 µx

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 5¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 6X¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 6X¹ 4,4 µx

Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum xxxxxxxxx 7X¹ 2,2 µx

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 9X¹ 2,2 µx

Xxxxxxxxxxxx pneumoniae polysaccharidum xxxxxxxxx 14¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 18C¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 19A¹ 2,2 µx

Xxxxxxxxxxxx pneumoniae 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 xxxxxxxx xxxxx xxxxxxxx:

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

1x) očkovací látka xxxxx xxxxxxx, dávivému xxxxx (acelulární forma), xxxxxx, dětské xxxxxxxx xxxxx (xxxxxxxxxxxx xxxxx):

Xxxxx xxxxx (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx xxxxxxxxxx¹ - xx xxxx xxx 2 xxxxxxxxxxx jednotky (XX) (2,5 Xx)

Xxxxxx 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 antigenu

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

typus 3 (xxxx Xxxxxxx)² 32 X xxxxxxxx xxxxxxxx

¹ xxxxxxxxxxx na xxxxxxxxxxx xxxxxxxx xxxxxxx (Xx(XX)₃) 0,3 xxxxxxxxx Xx³⁺ x fosforečnan xxxxxxx (AlPO₄) 0,2 xxxxxxxxx Al³⁺

² pomnoženo xx XXXX xxxxxxx

XXXX

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

Xxxxx dávka (0,5 ml) obsahuje:

Diphtheriae xxxxxxxxxx minimálně 2 XX¹ (2 Lf)

Tetani xxxxxxxxxx minimálně 20 XX¹ (5 Xx)

Xxxxxxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxxx 2,5 xxxxxxxxxx

Xxxxxxxxx haemagglutininum xxxxxxxxxxxx 5 mikrogramů

Pertactinum 3 xxxxxxxxxx

Xxxxxxxx, xxxx 2 xx 3 5 xxxxxxxxxx

Xxxxx poliomyelitidis (xxxxxxxxxxx)²

xxxxx 1 (Xxxxxxx) 29 X xxxxxxxx xxxxxxxx³

xxxxx 2 (XXX1) 7 X xxxxxxxx xxxxxxxx³

xxxxx 3 (Xxxxxxx) 26 X jednotek antigenu³

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

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

² Xxxxxxxxxxx na Xxxx xxxxxxx

³ Xxxx xxxxxxxx xxxxxxxx jsou xxxxx xxxxxx xxxx xx, xxxxx xxxx dříve xxxxxxxxx xxxx 40-8-32 X xxxxxxxx xxxxxxxx xxx xxxxx xxxx 1, 2 x 3, xxx xxxxxx xxxxx xxxxxxx imunochemickou xxxxxxx

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

** Xxxxxxxxxxx xx Vero xxxxxxx.

1x) xxxxxxxx látka xxxxx xxxxxxxxxxx (BCG xxxxxxx)

1x) xxxxxxxx xxxxx xxxxx xxxxxx hepatitidě B xxx osoby xxxxxxxx xx xxxxxxxxxxxx xxxxxxxx:

Xxxxx xxxxx (0,5 ml) xxxxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx X^1,2,3 - 20 mikrogramů

¹ xxxxxxxxxx xx XX04X xxxxxxxxxx: - 3-O-deacyl-4'-monofosforyl-lipid X (XXX)² 50 xxxxxxxxxx

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

³ xxxxxxxx xx xxxxxxx kvasinkových xxxxx (Xxxxxxxxxxxxx xxxxxxxxxx) xxxxxxxxxxxxx DNA xxxxxxxxxxx.

2. Xxxxxxxxx xxxxxxx očkovacích xxxxx xxx xxxxxxxx xxxxxxxx

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

Xxxxx xxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx X - 20 xxxxxxxxxx

2x) xxxxxxxx xxxxx xxxxx vzteklině

2c) očkovací xxxxx proti virové xxxxxxxxxx X xx xxxxxxx pro xxxxxxx:

Xxxxx xxxxx obsahuje:

Hepatitis A xxxxx inactivatum

2d) xxxxxxxx xxxxx xxxxx xxxxxxxxxx, xxxxxxxxxx x xxxxxxxxx:

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

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

Xxxxxxxxxxx xxxxx attenuatum¹ (XXX 4385) min. 10^3,7 infekční dávka xxx xxxxxxxx kulturu₅₀³

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

¹ xxxxxxxxx xx buňkách xxxxxxxx xxxxxx

² xxxxxxxxx xx xxxxxxxx xxxxxxxxxxx xxxxxxx (MRC-5)

³ 50% xxxxxxxx xxxxx xxxxxxx xxxxxxx

XXXX

2xx) xxxxxxxx látka xxxxx spalničkám, xxxxxxxxxx x xxxxxxxxx

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

Virus xxxxxxxxxxx¹ xxxxx attenuatum (xxxx Xxxxxx’ Edmonston) xx xxxx než 1x10³ XXXX₅₀*

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

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

* 50% xxxxxxxx xxxxx buněčné xxxxxxx

¹ xxxxxxxx xx xxxxxxx kuřecích embryí

² xxxxxxxx na xxxxxxxx xxxxxxxxxxx buňkách XX-38 xxxxxxxxxxxxx.

3. Xxxxxxxxx složení xxxxxxxxxx xxxxx xxx xxxxxxxxx xxxxxxxx

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

Virus xxxxxxxxx A inactivatum

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

Xxxxx xxxxxxxxx X xxxxxxxxxxx

3x) xxxxxxxx látka xxxxx spalničkám, xxxxxxxxxx x zarděnkám:

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

Xxxxxxxxxxx xxxxx xxxxxxxxxx¹ (Xxxxxxx) min. 10^3,0 infekční xxxxx xxx xxxxxxxx xxxxxxx₅₀³

Xxxxxxxxxxx xxxxx attenuatum¹ (XXX 4385) min. 10^3,7 xxxxxxxx xxxxx xxx xxxxxxxx kulturu₅₀³

Rubeolae xxxxx xxxxxxxxxx² (Wistar RA 27/3) min. 10^3,0 xxxxxxxx xxxxx pro xxxxxxxx xxxxxxx₅₀³

¹ xxxxxxxxx xx xxxxxxx xxxxxxxx xxxxxx

² pomnoženo xx xxxxxxxx xxxxxxxxxxx xxxxxxx (XXX-5)

³ 50% infekční xxxxx tkáňové xxxxxxx

XXXX

3xx) xxxxxxxx látka xxxxx xxxxxxxxxx, xxxxxxxxxx x xxxxxxxxx

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

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

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

Xxxxx rubeolae² xxxxx xxxxxxxxxx (xxxx Xxxxxx XX 27/3) xx xxxx xxx 1x110³ XXXX₅₀*

* 50% xxxxxxxx xxxxx xxxxxxx xxxxxxx

¹ xxxxxxxx xx buňkách xxxxxxxx xxxxxx

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

Xxxxxxx:

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

Xxxxxxxxx

Xxxxxx xxxxxxx x. 375/2024 Sb. xxxxx xxxxxxxxx xxxx 10.12.2024.

Ke xxx xxxxxxxx nebyl xxxxx xx doplňován.

Znění xxxxxxxxxxxx právních xxxxx xxxxxx xxxxxxxx předpisů x xxxxxxxx xxxx xxxxxxxxxxxxx, xxxxx xx xxxx xxxxxx xxxxxxxxx xxxxx shora xxxxxxxxx xxxxxxxx xxxxxxxx.