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

SDĚLENÍ

Ministerstva xxxxxxxxxxxxx

xx xxx 5. xxxxxxxx 2024

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

Xxxxxxxxxxxx xxxxxxxxxxxxx xxxxx §80 xxxx. 1 xxxx. x) zákona x. 258/2000 Xx., x xxxxxxx xxxxxxxxx xxxxxx a x xxxxx xxxxxxxxx souvisejících xxxxxx, ve xxxxx xxxxxxxxxx předpisů, xxxxxxx xx xxxxxxx doporučení Xxxxxxx xxxxxxxxxx komise xxxxxxxxx složení xxxxxxxxxx xxxxx xxx pravidelná, xxxxxxxx x xxxxxxxxx xxxxxxxx pro rok 2025:

1. Xxxxxxxxx složení xxxxxxxxxx xxxxx pro xxxxxxxxxx xxxxxxxx

1x) kombinovaná xxxxxxxx xxxxx proti xxxxxxx, xxxxxxxx xxxxx (xxxxxxxxxx forma), tetanu, xxxxxx xxxxxxxx xxxxx (xxxxxxxxxxxx forma), xxxxxx xxxxxxxxxx X, xxxxxxx xxxxxxxxx Haemophilus influenzae xxx x (XXxXXxxXXXXXX)

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

Xxxxxxxxxxx xxxxxxxxxx¹ xx xxxx xxx 30 xxxxxxxxxxxxx xxxxxxxx (XX)

Xxxxxx xxxxxxxxxx1 xx méně xxx 40 xxxxxxxxxxxxx xxxxxxxx (XX)

Xxxxxxxx Xxxxxxxxxx pertussis:

Pertussis xxxxxxxxxx (PT)¹ 25 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxxxx xxxxxxxxxxxx (XXX)¹ 25 mikrogramů

Pertactinum (XXX)¹ 8 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxx hepatitidis X (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 jednotek xxxxxxxx

Xxxxxxxxxxx influenzae typus x xxxxxxxxxxxxxxx

(Xxxxxxxxxxxxxxxxxxx xxxxxxxx) 10 mikrogramů

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

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

² xxxxxxxx xxxxxxxxxxxxx XXX technologií xx kultuře kvasinkových xxxxx (Xxxxxxxxxxxxx xxxxxxxxxx)

³ xxxxxxxxxxx na fosforečnan xxxxxxx (AlPO₄) 0,32 xxxxxxxxx Al³⁺

⁴ xxxxxxxxx xx VERO buňkách

NEBO

1aa) xxxxxxxxxxx očkovací xxxxx xxxxx xxxxxxx, xxxxxxxx xxxxx (xxxxxxxxxx forma), xxxxxx, dětské xxxxxxxx xxxxx (xxxxxxxxxxxx xxxxx), xxxxxx hepatitidě X, xxxxxxx vyvolaným Xxxxxxxxxxx xxxxxxxxxx typ x (XXxXXxxXXXXXX)

Xxxxx xxxxx¹ (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx anatoxinum xx xxxx xxx 20 xxxxxxxxxxxxx jednotek (XX)^2,4 (30 Xx)

Xxxxxx xxxxxxxxxx xx méně xxx 40 xxxxxxxxxxxxx xxxxxxxx (IU)^3,4 (10 Xx)

Xxxxxxxx Xxxxxxxxxx xxxxxxxxx

Xxxxxxxxx xxxxxxxxxx 25 mikrogramů

Pertussis xxxxxxxxxxxxxxxx xxxxxxxxxxxx 25 xxxxxxxxxx

Xxxxx Xxxxxxxxxxxxxxx (inaktivovaný)⁵

typus 1 (Xxxxxxx) 29 X xxxxxxxx xxxxxxxx⁶

xxxxx 2 (MEF-1) 7 X xxxxxxxx xxxxxxxx⁶

xxxxx 3 (Xxxxxxx) 26 X jednotek antigenu⁶

Tegiminis xxxxxxxxxxx X xxxxxxxxx⁷ 10 mikrogramů

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

¹ Adsorbováno xx xxxxxxxxxxx xxxxxxxx hlinitý (0,6 xx Al³⁺)

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

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

⁴ Nebo xxxxxxxxxxxx xxxxxxxx xxxxxxxxx xxxxxxxxxx xxxxxxxxxxx

⁵ Xxxxxxxxxxx xx Xxxx xxxxxxx

⁶ Xxxx xxxxxxxx xxxxxxxx xxxx xxxxx stejná xxxx ta, xxxxx xxxx xxxxx xxxxxxxxx xxxx 40-8-32 D xxxxxxxx antigenu xxx xxxxx xxxx 1, 2 x 3, xxx xxxxxx xxxxx xxxxxxx xxxxxxxxxxxxxx xxxxxxx

⁷ xxxxxxxx rekombinantní DNA xxxxxxxxxxx x xxxxxxxxxxxx xxxxxxx Xxxxxxxxx polymorpha

NEBO

1ab) Xxxxxxx xxxxx xxxxxxx, xxxxxx, xxxxxxxx xxxxx (xxxxxxxxxx xxxxxxxxxx), hepatitidě X (rDNA), xxxxxx xxxxxxxx xxxxx (xxxxxxxxxxxx) x xxxxxxxxxxx xxxxxxx xxxxx Xxxxxxxxxxx xxxx x (xxxxxxxxxxx)

Xxxxx xxxxx (0,5 xx) obsahuje:

Diphtheriae xxxxxxxxxx1 xx xxxx xxx 20 XX⁶

Xxxxxx xxxxxxxxxx1 ne méně xxx 40 IU⁶

Antigena Xxxxxxxxxxx xxxxxxxx¹

Xxxxxxxxx anatoxinum (XX) 20 xxxxxxxxxx

Xxxxxxxxxxxxxxx xxxxxxxxxxxx (FHA) 20 xxxxxxxxxx

Xxxxxxxxxxx (PRN) 3 xxxxxxxxxx

Xxxxxxxx typi 2 xx 3 (XXX) 5 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx B ^2,3 10 mikrogramů

Virus xxxxxxxxxxxxxxx (xxxxxxxxxxx)⁴

Xxxxx 1 (Xxxxxxx) 40 X xxxxxxxx xxxxxxxx⁵

Xxxxx 2 (XXX-1) 8 X xxxxxxxx xxxxxxxx⁵

Xxxxx 3 (Xxxxxxx) 32 D jednotek xxxxxxxx⁵

Xxxxxxxxxxxxxx Xxxxxxxxxx xxxxxxxxxx xxxxx x

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

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

² xxxxxxxxxxx xx xxxxxxxxxxx hydroxid xxxxxxx xxxxxx (0,15 xx Al³⁺)

³ xxxxxxxx xxxxxxxxxxxxx XXX xxxxxxxxxxx x xxxxxxxxxxxx xxxxxxx Xxxxxxxxxxxxx xxxxxxxxxx

⁴ xxxxxxxxx xx Vero buňkách

⁵ xxxx xxxxxxxxxxxx množství xxxxxxxx xxxxxxxxx xxxxxxx xxxxxxxxxxxxxx metodou

⁶ nebo xxxxxxxxxxxx xxxxxxxx xxxxxxxxx xxxxxxxxxxxx imunogenity

1b) xxxxxxxx xxxxx xxxxx xxxxxxx, xxxxxxxx xxxxx (acelulární xxxxx), xxxxxx (XXxX)

Xxxxx xxxxx (0,5 ml) xxxxxxxx xxxx xxxxxx xxxxx:

Xxxxxxxxxxx anatoxinum* ≥ 30 IU

Tetani xxxxxxxxxx* ≥ 40 XX

Xxxxxxxxx xxxxxxxxxx* (PT) 25 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxxxxx* (XXX) 25 xxxxxxxxxx

Xxxxxxxxxxx* (69xX) 8 mikrogramů

* xxxxxxxxxxx xx hydroxid xxxxxxx xxxxxx: 0,5 xxxxxxxxx

XXXX

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

Xxxxx xxxxx (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx xxxxxxxxxx - Xxxxxxxxx 2 IU* (2 Xx)

Xxxxxx xxxxxxxxxx - Xxxxxxxxx 20 XX* (5 Lf)

Pertusové xxxxxxxx

Xxxxxxxxx xxxxxxxxxx - 2,5 xxxxxxxxxx

Xxxxxxxxxxxxxx xxxxxxxxxxxx - 5 xxxxxxxxxx

Xxxxxxxxxxx - 3 mikrogramy

Fimbriae, xxxx 2 et 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) Xxxxxxxx xxxxx xxxxx záškrtu, xxxxxx x xxxxxxxx xxxxx (xxxxxxxxxx xxxxxxxxxx) xx sníženým xxxxxxx xxxxxxxx (Xxxx)

Xxxxx dávka (0,5 xx) xxxxxxxx:

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

Xxxxxx anatoxinum¹ xx xxxx než 20 xxxxxxxxxxxxx jednotek (XX) (5 Xx)

Xxxxxxxxxxx xxxxxxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxxx¹ 8 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxx filamentosum¹ 8 mikrogramů

Pertactinum¹ 2,5 xxxxxxxxxx

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

1c) xxxxxxxx xxxxx xxxxx xxxxxxx xxxxxxxxx Xxxxxxxxxxx influenzae xxx b:

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

Xxxxxxxxxxx xxxxxxxxxx xxxxx x xxxx xxxxxxxxxxx 10 xxxxxxxxxx

xxxxxxxxxxx x xxxxxxxxxx xxxxxxxx xxxx xxxxxxxxxxx nosičem xxxxxxxxx 25 mikrogramů

1d) xxxxxxxx xxxxx xxxxx xxxxxx:

Xxxxx dávka xxxxxxxx:

Xxxxxx xxxxxxxxxx - xxx. 40 mezinárodních jednotek

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

Xxxxx xxxxx xxxxxxxx:

Xxxxxxxxx tegiminis xxxxxxxxxxx X - 10 mikrogramů

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

Xxxxx dávka xxxxxxxx:

Xxxxxxxxx xxxxxxxxx hepatitidis X - 20 xxxxxxxxxx

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

xxxxx xxxxxxxxxxxxxxx xxxxxxx (0,5 ml) xxxxxxxx:

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

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

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

¹ xxxxxxxxx na xxxxxxx xxxxxxxx xxxxxx

² xxxxxxxxx xx lidských xxxxxxxxxxx xxxxxxx (XXX-5)

³ 50% infekční xxxxx xxxxxxx xxxxxxx

XXXX

1xx) xxxxxxxx xxxxx proti xxxxxxxxxx, xxxxxxxxxx x xxxxxxxxx

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

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

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

Xxxxx xxxxxxxx² vivum xxxxxxxxxx (xxxx Xxxxxx XX 27/3) ne méně xxx 1x10³ XXXX₅₀*

* 50% infekční dávka xxxxxxx xxxxxxx

¹ xxxxxxxx xx xxxxxxx xxxxxxxx xxxxxx.

² vyrobeno xx xxxxxxxx xxxxxxxxxxx xxxxxxxx XX-38 xxxxxxxxxxxxx

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

Xxxxx xxxxx (0,5 xx) xxxxxxxx:

Xxxxx xxxxxxxxxxxxx inactivatum xxxxx 1 (Xxxxxxx) ... 29 antigenních D xxxxxxxx**

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

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

* Xxxxxxxxxxx xx XXXX xxxxxxx

** Xxxx xxxxxxxx xxxxxxxx jsou xxxxx stejná xxxx xx, xxxxx byla xxxxx xxxxxxxxx jako 40-8-32 X xxxxxxxx xxxxxxxx xxx xxxxx xxxx 1, 2 x 3, xxx xxxxxx xxxxx vhodnou xxxxxxxxxxxxxx xxxxxxx

1xx) xxxxxxxxxxx xxxxxxxx látka xxxxx xxxxxxxxxxxxx xxxxxxxx

Xxxxx xxxxx (0,5 xx) xxxxxxxx:

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

polysacharid xxxxxxxx (xxxxxxxxxx) Streptococcus xxxxxxxxxx xxxxxxxx 3 ^1,2 2,2 µg

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

NEBO

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

1chaa) xxxxxxxxxxx xxxxxxxx látka obsahuje:

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

Xxxxxxxxxxxx xxxxxxxxxx serotypi 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 serotypi 6A^1,2 xxxxxxxxxxxxxxx 2,0 mikrogramů

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

Streptococci xxxxxxxxxx serotypi 7F^1,2 xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx

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

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

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

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

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

¹ Xxxxxxxxxx x xxxxxxxxxxx xxxxxxx XXX₁₉₇, XXX₁₉₇ xx netoxická xxxxxx xxxxxxxxxxxx xxxxxx (pocházejícího x Xxxxxxxxxxxxxxx xxxxxxxxxxx X7) rekombinantně exprimováného x Xxxxxxxxxxx fluorescens

² Xxxxxxxxxx na xxxxxxxx xxxxxxxxxxx xxxxxxx

X

1xxxx) xxxx xxxxxxxxxxx očkovací látka xxxxxxxx:

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

XXXX

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

1xxxx) xxxxxxxxxxx očkovací xxxxx obsahuje:

Streptococci pneumoniae xxxxxxxxxxxxxxx sérotypus 1¹ 2,2µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 3¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum xxxxxxxxx 4¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum xxxxxxxxx 5¹ 2,2 µx

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 6A¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 6X¹ 4,4 µx

Xxxxxxxxxxxx pneumoniae polysaccharidum xxxxxxxxx 7X¹ 2,2 µx

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 9X¹ 2,2 µx

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 14¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 18X¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 19X¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 19X¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum xxxxxxxxx 23X¹ 2,2 µx

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

X

1xxxx) póly xxxxxxxxxxx xxxxxxxx látka xxxxxxxx:

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

1x) očkovací látka xxxxx xxxxxxx, dávivému xxxxx (xxxxxxxxxx xxxxx), xxxxxx, dětské přenosné xxxxx (inaktivovaná forma):

Jedna xxxxx (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx anatoxinum¹ - xx xxxx xxx 2 xxxxxxxxxxx xxxxxxxx (XX) (2,5 Xx)

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

Xxxxxxxxxxx xxxxxxxxx antigena:

Pertussis xxxxxxxxxx¹ - 8 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxx xxxxxxxxxxxx¹ - 8 mikrogramů

Pertaktin1 2,5 xxxxxxxxxx

Xxxxx xxxxxxxxxxxxxxx xxxxxxxxxxx:

xxxxx 1 (xxxx Xxxxxxx)² 40 X xxxxxxxx xxxxxxxx

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

xxxxx 3 (kmen Saukett)² 32 X jednotek xxxxxxxx

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

² pomnoženo xx XXXX xxxxxxx

XXXX

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

Jedna dávka (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx xxxxxxxxxx minimálně 2 XX¹ (2 Lf)

Tetani xxxxxxxxxx minimálně 20 XX¹ (5 Xx)

Xxxxxxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxxx 2,5 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxxxx xxxxxxxxxxxx 5 xxxxxxxxxx

Xxxxxxxxxxx 3 xxxxxxxxxx

Xxxxxxxx, xxxx 2 xx 3 5 xxxxxxxxxx

Xxxxx xxxxxxxxxxxxxxx (xxxxxxxxxxx)²

xxxxx 1 (Mahoney) 29 X xxxxxxxx xxxxxxxx³

xxxxx 2 (XXX1) 7 X jednotek xxxxxxxx³

xxxxx 3 (Xxxxxxx) 26 X xxxxxxxx antigenu³

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

¹ Jako xxxxxx xxxxxxx xxxxxxxxx xxxxxxxxxxxxx (x = 0,95) xxxxxxxx xxxxxx xxxxx xxxxx xxxxxxxxx x Xxxxxxxxx xxxxxxxx

² Xxxxxxxxxxx xx Xxxx xxxxxxx

³ Xxxx množství xxxxxxxx xxxx xxxxx xxxxxx xxxx ta, xxxxx byla dříve xxxxxxxxx xxxx 40-8-32 X xxxxxxxx xxxxxxxx xxx virus typu 1, 2 x 3, při měření xxxxx xxxxxxx imunochemickou xxxxxxx

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

** Xxxxxxxxxxx xx Vero xxxxxxx.

1x) xxxxxxxx látka xxxxx xxxxxxxxxxx (BCG vakcína)

1k) xxxxxxxx xxxxx xxxxx xxxxxx hepatitidě X xxx xxxxx zařazené xx dialyzačního xxxxxxxx:

Xxxxx xxxxx (0,5 xx) xxxxxxx obsahuje:

Antigenum 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 na xxxxxxxxxxx xxxxxxx (xxxxxx 0,5 xxxxxxxxx Xx³⁺)

³ xxxxxxxx xx xxxxxxx kvasinkových xxxxx (Xxxxxxxxxxxxx cerevisiae) xxxxxxxxxxxxx XXX xxxxxxxxxxx.

2. Xxxxxxxxx xxxxxxx xxxxxxxxxx xxxxx xxx zvláštní xxxxxxxx

2x) xxxxxxxx xxxxx xxxxx virové hepatitidě X xx formuli xxx xxxxxxx:

Xxxxx dávka xxxxxxxx:

Xxxxxxxxx tegiminis xxxxxxxxxxx X - 20 xxxxxxxxxx

2x) xxxxxxxx látka xxxxx xxxxxxxxx

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

Xxxxx xxxxx obsahuje:

Hepatitis X xxxxx xxxxxxxxxxx

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

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

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

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

Xxxxxxxx xxxxx xxxxxxxxxx² (Xxxxxx XX 27/3) xxx. 10^3,0 xxxxxxxx xxxxx xxx xxxxxxxx kulturu₅₀³

¹ xxxxxxxxx xx buňkách xxxxxxxx xxxxxx

² xxxxxxxxx xx lidských xxxxxxxxxxx xxxxxxx (MRC-5)

³ 50% xxxxxxxx xxxxx xxxxxxx xxxxxxx

XXXX

2xx) xxxxxxxx látka xxxxx xxxxxxxxxx, příušnicím x zarděnkám

Po rozpuštění xxxxxxxx jedna dávka (0,5 ml):

Virus morbillorum¹ xxxxx xxxxxxxxxx (xxxx Xxxxxx’ Xxxxxxxxx) ne xxxx xxx 1x10³ XXXX₅₀*

Xxxxx xxxxxxxxxxx¹ vivum xxxxxxxxxx (xxxx Jeryl Xxxx™, hladina X) xx xxxx xxx 12,5x10³ XXXX₅₀*

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

* 50% xxxxxxxx xxxxx xxxxxxx xxxxxxx

¹ xxxxxxxx na xxxxxxx xxxxxxxx xxxxxx

² xxxxxxxx xx xxxxxxxx xxxxxxxxxxx buňkách WI-38 xxxxxxxxxxxxx.

3. Xxxxxxxxx xxxxxxx xxxxxxxxxx xxxxx xxx xxxxxxxxx xxxxxxxx

3x) očkovací xxxxx xxxxx xxxxxx xxxxxxxxxx A xx xxxxxxx xxx xxxxxxx:

Xxxxx xxxxxxxxx X inactivatum

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

Xxxxx xxxxxxxxx X xxxxxxxxxxx

3x) xxxxxxxx xxxxx xxxxx spalničkám, příušnicím x xxxxxxxxx:

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

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

Parotitidis xxxxx attenuatum¹ (RIT 4385) xxx. 10^3,7 xxxxxxxx xxxxx pro xxxxxxxx xxxxxxx₅₀³

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

¹ xxxxxxxxx xx xxxxxxx xxxxxxxx xxxxxx

² xxxxxxxxx xx xxxxxxxx xxxxxxxxxxx buňkách (XXX-5)

³ 50% xxxxxxxx xxxxx tkáňové xxxxxxx

XXXX

3xx) xxxxxxxx xxxxx proti xxxxxxxxxx, příušnicím a xxxxxxxxx

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

Xxxxx xxxxxxxxxxx¹ vivum xxxxxxxxxx (xxxx Enders’ Xxxxxxxxx) xx xxxx xxx 1x10³ CCID₅₀*

Virus xxxxxxxxxxx¹ vivum xxxxxxxxxx (xxxx Jeryl Lynn™, xxxxxxx B) xx xxxx než 12,5x10³ XXXX₅₀*

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

* 50% xxxxxxxx xxxxx buněčné xxxxxxx

¹ xxxxxxxx xx xxxxxxx xxxxxxxx embryí

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

Xxxxxxx:

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

Xxxxxxxxx

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

Ke xxx xxxxxxxx xxxxx xxxxx xx xxxxxxxxx.

Xxxxx xxxxxxxxxxxx xxxxxxxx xxxxx xxxxxx xxxxxxxx předpisů x xxxxxxxx xxxx xxxxxxxxxxxxx, xxxxx xx xxxx xxxxxx xxxxxxxxx xxxxx xxxxx xxxxxxxxx xxxxxxxx xxxxxxxx.