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 xxxxxxx xxxxxxxxxx xxxxx xxx xxxxxxxxxx, xxxxxxxx x mimořádná xxxxxxxx xxx rok 2025
&xxxx;

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

1. Antigenní xxxxxxx xxxxxxxxxx xxxxx pro xxxxxxxxxx xxxxxxxx

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

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

Xxxxxxxxxxx xxxxxxxxxx¹ ne xxxx xxx 30 mezinárodních xxxxxxxx (XX)

Xxxxxx xxxxxxxxxx1 xx xxxx než 40 xxxxxxxxxxxxx xxxxxxxx (XX)

Xxxxxxxx Xxxxxxxxxx xxxxxxxxx:

Xxxxxxxxx xxxxxxxxxx (XX)¹ 25 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxxxx xxxxxxxxxxxx (XXX)¹ 25 xxxxxxxxxx

Xxxxxxxxxxx (XXX)¹ 8 xxxxxxxxxx

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

Xxxxx xxxxxxxxxxxxxxx xxxxxxxxxxx (XXX)

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

xxxxx 2 (xxxx XXX-1)⁴ 8 X xxxxxxxx xxxxxxxx

xxxxx 3 (xxxx Xxxxxxx)⁴ 32 D jednotek xxxxxxxx

Xxxxxxxxxxx influenzae typus x xxxxxxxxxxxxxxx

(Xxxxxxxxxxxxxxxxxxx xxxxxxxx) 10 xxxxxxxxxx

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

¹ xxxxxxxxxxx xx xxxxxxxx xxxxxxx, xxxxxxxxxxx (Xx(XX)₃) 0,5 xxxxxxxxx Xx³⁺

² xxxxxxxx xxxxxxxxxxxxx DNA xxxxxxxxxxx xx xxxxxxx kvasinkových xxxxx (Xxxxxxxxxxxxx cerevisiae)

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

⁴ xxxxxxxxx xx VERO xxxxxxx

XXXX

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

Xxxxx xxxxx¹ (0,5 xx) obsahuje:

Diphtheriae anatoxinum xx xxxx xxx 20 mezinárodních jednotek (XX)^2,4 (30 Xx)

Xxxxxx xxxxxxxxxx xx xxxx 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 (Mahoney) 29 X xxxxxxxx antigenu⁶

typus 2 (XXX-1) 7 X xxxxxxxx antigenu⁶

typus 3 (Xxxxxxx) 26 X xxxxxxxx xxxxxxxx⁶

Xxxxxxxxx xxxxxxxxxxx X antigenum⁷ 10 xxxxxxxxxx

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

¹ Adsorbováno na xxxxxxxxxxx xxxxxxxx xxxxxxx (0,6 mg Xx³⁺)

² Xxxx xxxxxx xxx xxxxxxxxxxxxx (x = 0,95) a xx xxxx xxx 30 XX jako střední xxxxxxx

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

⁴ Xxxx xxxxxxxxxxxx aktivita xxxxxxxxx xxxxxxxxxx xxxxxxxxxxx

⁵ Xxxxxxxxxxx xx Xxxx xxxxxxx

⁶ Xxxx množství xxxxxxxx xxxx xxxxx xxxxxx xxxx xx, xxxxx xxxx xxxxx xxxxxxxxx xxxx 40-8-32 X xxxxxxxx xxxxxxxx pro xxxxx xxxx 1, 2 a 3, xxx měření xxxxx xxxxxxx imunochemickou metodou

⁷ xxxxxxxx xxxxxxxxxxxxx XXX xxxxxxxxxxx x kvasinkových xxxxxxx Xxxxxxxxx xxxxxxxxxx

XXXX

1xx) Xxxxxxx proti xxxxxxx, xxxxxx, xxxxxxxx xxxxx (xxxxxxxxxx komponenta), xxxxxxxxxx X (rDNA), xxxxxx xxxxxxxx xxxxx (xxxxxxxxxxxx) x xxxxxxxxxxx xxxxxxx xxxxx Xxxxxxxxxxx xxxx x (xxxxxxxxxxx)

Xxxxx xxxxx (0,5 xx) obsahuje:

Diphtheriae xxxxxxxxxx1 ne xxxx xxx 20 XX⁶

Xxxxxx xxxxxxxxxx1 xx xxxx xxx 40 XX⁶

Xxxxxxxx Xxxxxxxxxxx xxxxxxxx¹

Xxxxxxxxx anatoxinum (XX) 20 xxxxxxxxxx

Xxxxxxxxxxxxxxx xxxxxxxxxxxx (XXX) 20 xxxxxxxxxx

Xxxxxxxxxxx (PRN) 3 xxxxxxxxxx

Xxxxxxxx xxxx 2 xx 3 (XXX) 5 mikrogramů

Antigenum xxxxxxxxx xxxxxxxxxxx X ^2,3 10 xxxxxxxxxx

Xxxxx xxxxxxxxxxxxxxx (xxxxxxxxxxx)⁴

Xxxxx 1 (Xxxxxxx) 40 X jednotek xxxxxxxx⁵

Xxxxx 2 (XXX-1) 8 D jednotek xxxxxxxx⁵

Xxxxx 3 (Xxxxxxx) 32 D xxxxxxxx xxxxxxxx⁵

Xxxxxxxxxxxxxx Haemophili xxxxxxxxxx xxxxx x

(Xxxxxxxxxxxxxxxxxxx xxxxxxxx) 3 xxxxxxxxxx xxxxxxxxxx xxx xxxxxxxxx xxxxxxxxxxxx xxxxx b² 50 xxxxxxxxxx

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

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

³ xxxxxxxx xxxxxxxxxxxxx DNA xxxxxxxxxxx x xxxxxxxxxxxx xxxxxxx Xxxxxxxxxxxxx cerevisiae

⁴ pomnoženo xx Xxxx xxxxxxx

⁵ xxxx xxxxxxxxxxxx xxxxxxxx xxxxxxxx xxxxxxxxx xxxxxxx xxxxxxxxxxxxxx xxxxxxx

⁶ nebo xxxxxxxxxxxx xxxxxxxx stanovená xxxxxxxxxxxx xxxxxxxxxxx

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

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

Xxxxxxxxxxx xxxxxxxxxx* ≥ 30 XX

Xxxxxx xxxxxxxxxx* ≥ 40 XX

Xxxxxxxxx xxxxxxxxxx* (XX) 25 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxxx filamentosum* (XXX) 25 xxxxxxxxxx

Xxxxxxxxxxx* (69xX) 8 xxxxxxxxxx

* xxxxxxxxxxx na hydroxid xxxxxxx xxxxxx: 0,5 xxxxxxxxx

XXXX

1xx) Očkovací xxxxx xxxxx záškrtu, xxxxxx x xxxxxxxx kašli (xxxxxxxxxx) xx sníženým xxxxxxx antigenů (Xxxx)

Xxxxx xxxxx (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx xxxxxxxxxx - Xxxxxxxxx 2 XX* (2 Xx)

Xxxxxx anatoxinum - Xxxxxxxxx 20 XX* (5 Xx)

Xxxxxxxxx xxxxxxxx

Xxxxxxxxx xxxxxxxxxx - 2,5 xxxxxxxxxx

Xxxxxxxxxxxxxx xxxxxxxxxxxx - 5 xxxxxxxxxx

Xxxxxxxxxxx - 3 mikrogramy

Fimbriae, xxxx 2 xx 3 - 5 xxxxxxxxxx

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

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

XXXX

1xx) Xxxxxxxx xxxxx proti záškrtu, xxxxxx a dávivému xxxxx (acelulární xxxxxxxxxx) xx sníženým obsahem xxxxxxxx (Tdap)

Jedna xxxxx (0,5 xx) obsahuje:

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

Xxxxxx anatoxinum¹ xx xxxx než 20 xxxxxxxxxxxxx xxxxxxxx (IU) (5 Xx)

Xxxxxxxxxxx pertussis xxxxxxxx:

Xxxxxxxxx xxxxxxxxxx¹ 8 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxx xxxxxxxxxxxx¹ 8 xxxxxxxxxx

Xxxxxxxxxxx¹ 2,5 xxxxxxxxxx

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

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

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

Haemophilus xxxxxxxxxx xxxxx b xxxx xxxxxxxxxxx 10 xxxxxxxxxx

xxxxxxxxxxx x tetanickým toxoidem xxxx xxxxxxxxxxx xxxxxxx xxxxxxxxx 25 xxxxxxxxxx

1x) xxxxxxxx xxxxx xxxxx xxxxxx:

Xxxxx xxxxx xxxxxxxx:

Xxxxxx xxxxxxxxxx - xxx. 40 xxxxxxxxxxxxx xxxxxxxx

1x) xxxxxxxx látka xxxxx xxxxxx hepatitidč X x dětské formuli:

Jedna xxxxx xxxxxxxx:

Xxxxxxxxx tegiminis xxxxxxxxxxx B - 10 mikrogramů

1f) xxxxxxxx xxxxx proti virové xxxxxxxxxx B v xxxxxxx xxxxxxx

Xxxxx dávka xxxxxxxx:

Xxxxxxxxx tegiminis xxxxxxxxxxx X - 20 xxxxxxxxxx

1x) xxxxxxxx xxxxx xxxxx spalničkám, příušnicím x zarděnkám:

dávka xxxxxxxxxxxxxxx xxxxxxx (0,5 xx) xxxxxxxx:

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

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

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

¹ xxxxxxxxx na xxxxxxx xxxxxxxx xxxxxx

² xxxxxxxxx na lidských xxxxxxxxxxx xxxxxxx (MRC-5)

³ 50% xxxxxxxx xxxxx xxxxxxx xxxxxxx

XXXX

1xx) xxxxxxxx xxxxx xxxxx spalničkám, xxxxxxxxxx a zarděnkám

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

Virus xxxxxxxxxxx¹ xxxxx xxxxxxxxxx (xxxx Enders’ Edmonston) xx xxxx xxx 1x10³ CCID₅₀*

Virus parotitidis¹ xxxxx xxxxxxxxxx (kmen Xxxxx Lynn™, hladina X) ne xxxx xxx 12,5x10³ XXXX₅₀*

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

* 50% xxxxxxxx xxxxx xxxxxxx kultury

¹ vyrobeno xx buňkách xxxxxxxx xxxxxx.

² xxxxxxxx xx xxxxxxxx xxxxxxxxxxx xxxxxxxx XX-38 fibroblastech

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

Xxxxx dávka (0,5 xx) xxxxxxxx:

Xxxxx xxxxxxxxxxxxx inactivatum xxxxx 1 (Mahoney) ... 29 antigenních X xxxxxxxx**

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

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

* Xxxxxxxxxxx na XXXX buňkách

** Tato xxxxxxxx xxxxxxxx xxxx xxxxx stejná xxxx xx, která byla xxxxx vyjádřená xxxx 40-8-32 X jednotek xxxxxxxx xxx virus xxxx 1, 2 x 3, při xxxxxx xxxxx xxxxxxx xxxxxxxxxxxxxx metodou

1ch) xxxxxxxxxxx xxxxxxxx xxxxx xxxxx xxxxxxxxxxxxx infekcím

Jedna dávka (0,5 xx) xxxxxxxx:

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

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

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

polysacharid xxxxxxxx (pneumokoka) Streptococcus xxxxxxxxxx xxxxxxxx 5 ^1,2 2,2 µx

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

NEBO

1cha) očkovací xxxxx proti pneumokokovým xxxxxxxx xxxxxxxxx v xxxxxxxxxx xxxxxxxx:

1xxxx) konjugovaná xxxxxxxx xxxxx obsahuje:

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

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

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

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 5^1,2 xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx

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

Xxxxxxxxxxxx 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 mikrogramů

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

Xxxxxxxxxxxx xxxxxxxxxx serotypi 19A^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 xxxxxxxxxx

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

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

¹ Xxxxxxxxxx x proteinovým xxxxxxx XXX₁₉₇, XXX₁₉₇ xx netoxická mutace xxxxxxxxxxxx toxinu (xxxxxxxxxxxxx x Corynebacterium diphtheriae X7) xxxxxxxxxxxxx exprimováného x Xxxxxxxxxxx fluorescens

² Xxxxxxxxxx na xxxxxxxx xxxxxxxxxxx xxxxxxx

X

1xxxx) xxxx xxxxxxxxxxx xxxxxxxx xxxxx 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, 23X, 33X

XXXX

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

1xxxx) xxxxxxxxxxx xxxxxxxx xxxxx obsahuje:

Streptococci pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 1¹ 2,2µx

Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum xxxxxxxxx 3¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 4¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum xxxxxxxxx 5¹ 2,2 µx

Xxxxxxxxxxxx pneumoniae polysaccharidum xxxxxxxxx 6X¹ 2,2 µx

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 6X¹ 4,4 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 7X¹ 2,2 µx

Xxxxxxxxxxxx pneumoniae polysaccharidum xxxxxxxxx 9X¹ 2,2 µx

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 14¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum xxxxxxxxx 18X¹ 2,2 µx

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 19A¹ 2,2 µx

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 19X¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum xxxxxxxxx 23X¹ 2,2 µx

¹ Konjugován s xxxxxx xxxxxxxxx CRM₁₉₇ x xxxxxxxxxx xx xxxxxxxxxxx xxxxxxx (0,125 xx xxxxxxx)

X

1xxxx) xxxx xxxxxxxxxxx očkovací xxxxx xxxxxxxx:

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

1x) xxxxxxxx xxxxx xxxxx xxxxxxx, dávivému xxxxx (xxxxxxxxxx xxxxx), xxxxxx, xxxxxx xxxxxxxx xxxxx (xxxxxxxxxxxx xxxxx):

Xxxxx xxxxx (0,5 ml) xxxxxxxx:

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

Xxxxxx xxxxxxxxxx¹-&xxxx; ne xxxx xxx 20 mezinárodních xxxxxxxx (IU) (5 Xx)

Xxxxxxxxxxx xxxxxxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxxx¹ - 8 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxx xxxxxxxxxxxx¹ - 8 xxxxxxxxxx

Xxxxxxxxx1 2,5 xxxxxxxxxx

Xxxxx xxxxxxxxxxxxxxx xxxxxxxxxxx:

xxxxx 1 (kmen Xxxxxxx)² 40 D xxxxxxxx xxxxxxxx

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

xxxxx 3 (kmen Xxxxxxx)² 32 D xxxxxxxx xxxxxxxx

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

² pomnoženo xx XXXX buňkách

NEBO

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

Jedna xxxxx (0,5 xx) obsahuje:

Diphtheriae xxxxxxxxxx xxxxxxxxx 2 XX¹ (2 Lf)

Tetani xxxxxxxxxx xxxxxxxxx 20 XX¹ (5 Xx)

Xxxxxxxxx xxxxxxxx:

Xxxxxxxxx anatoxinum 2,5 xxxxxxxxxx

Xxxxxxxxx haemagglutininum xxxxxxxxxxxx 5 xxxxxxxxxx

Xxxxxxxxxxx 3 xxxxxxxxxx

Xxxxxxxx, xxxx 2 xx 3 5 xxxxxxxxxx

Xxxxx poliomyelitidis (inactivatum)²

typus 1 (Xxxxxxx) 29 X jednotek antigenu³

typus 2 (XXX1) 7 X jednotek xxxxxxxx³

xxxxx 3 (Xxxxxxx) 26 X jednotek antigenu³

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

¹ Jako xxxxxx hranice xxxxxxxxx xxxxxxxxxxxxx (x = 0,95) xxxxxxxx xxxxxx xxxxx testu popsaného x Xxxxxxxxx lékopisu

² Xxxxxxxxxxx na Vero xxxxxxx

³ Xxxx množství xxxxxxxx xxxx úplně xxxxxx xxxx xx, xxxxx byla xxxxx xxxxxxxxx xxxx 40-8-32 X xxxxxxxx antigenu xxx xxxxx xxxx 1, 2 x 3, při měření xxxxx vhodnou xxxxxxxxxxxxxx xxxxxxx

* Xxxx spodní xxxxxxx intervalu xxxxxxxxxxxxx (x = 0,95) xxxxxxxx měřené xxxxx xxxxx xxxxxxxxx x Xxxxxxxxx xxxxxxxx

** Xxxxxxxxxxx xx Xxxx xxxxxxx.

1x) xxxxxxxx xxxxx proti xxxxxxxxxxx (XXX vakcína)

1k) xxxxxxxx látka proti xxxxxx xxxxxxxxxx B xxx xxxxx zařazené xx xxxxxxxxxxxx programu:

Jedna xxxxx (0,5 xx) xxxxxxx xxxxxxxx:

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

¹ xxxxxxxxxx xx XX04X xxxxxxxxxx: - 3-X-xxxxxx-4'-xxxxxxxxxxxx-xxxxx X (XXX)² 50 xxxxxxxxxx

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

³ xxxxxxxx xx kultuře xxxxxxxxxxxx xxxxx (Saccharomyces cerevisiae) xxxxxxxxxxxxx XXX xxxxxxxxxxx.

2. Xxxxxxxxx xxxxxxx xxxxxxxxxx xxxxx xxx xxxxxxxx xxxxxxxx

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

Xxxxx dávka xxxxxxxx:

Xxxxxxxxx xxxxxxxxx hepatitidis X - 20 xxxxxxxxxx

2x) xxxxxxxx látka xxxxx vzteklině

2c) xxxxxxxx xxxxx proti xxxxxx xxxxxxxxxx X ve xxxxxxx pro dospělé:

Jedna xxxxx obsahuje:

Hepatitis A xxxxx xxxxxxxxxxx

2x) xxxxxxxx xxxxx xxxxx xxxxxxxxxx, xxxxxxxxxx x zarděnkám:

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

Xxxxxxxxxxx xxxxx xxxxxxxxxx¹ (Schwarz) xxx. 10^3,0 infekční xxxxx pro buněčnou xxxxxxx₅₀³

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

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

¹ xxxxxxxxx na buňkách xxxxxxxx xxxxxx

² pomnoženo xx xxxxxxxx xxxxxxxxxxx xxxxxxx (MRC-5)

³ 50% xxxxxxxx xxxxx tkáňové xxxxxxx

XXXX

2xx) xxxxxxxx xxxxx xxxxx xxxxxxxxxx, xxxxxxxxxx x xxxxxxxxx

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

Xxxxx xxxxxxxxxxx¹ xxxxx xxxxxxxxxx (xxxx Xxxxxx’ Xxxxxxxxx) ne xxxx než 1x10³ XXXX₅₀*

Xxxxx parotitidis¹ xxxxx xxxxxxxxxx (kmen Xxxxx Xxxx™, xxxxxxx B) xx xxxx než 12,5x10³ XXXX₅₀*

Xxxxx xxxxxxxx² xxxxx attenuatum (kmen Xxxxxx RA 27/3) xx méně xxx 1x10³ XXXX₅₀*

* 50% xxxxxxxx xxxxx xxxxxxx xxxxxxx

¹ xxxxxxxx xx xxxxxxx xxxxxxxx xxxxxx

² xxxxxxxx na xxxxxxxx xxxxxxxxxxx xxxxxxx XX-38 xxxxxxxxxxxxx.

3. Xxxxxxxxx složení xxxxxxxxxx xxxxx xxx xxxxxxxxx xxxxxxxx

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

Xxxxx xxxxxxxxx X inactivatum

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

Xxxxx xxxxxxxxx A xxxxxxxxxxx

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

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

Morbillorum virus xxxxxxxxxx¹ (Schwarz) xxx. 10^3,0 xxxxxxxx dávka xxx buněčnou xxxxxxx₅₀³

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

Xxxxxxxx virus xxxxxxxxxx² (Wistar RA 27/3) min. 10^3,0 xxxxxxxx dávka pro xxxxxxxx xxxxxxx₅₀³

¹ xxxxxxxxx xx xxxxxxx kuřecích xxxxxx

² xxxxxxxxx xx xxxxxxxx diploidních xxxxxxx (XXX-5)

³ 50% xxxxxxxx xxxxx tkáňové xxxxxxx

XXXX

3xx) xxxxxxxx xxxxx xxxxx xxxxxxxxxx, xxxxxxxxxx x xxxxxxxxx

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

Xxxxx xxxxxxxxxxx¹ xxxxx xxxxxxxxxx (xxxx Xxxxxx’ Xxxxxxxxx) xx xxxx xxx 1x10³ CCID₅₀*

Virus xxxxxxxxxxx¹ xxxxx attenuatum (xxxx Xxxxx Xxxx™, xxxxxxx X) ne xxxx xxx 12,5x10³ XXXX₅₀*

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

* 50% infekční xxxxx buněčné kultury

¹ xxxxxxxx na buňkách xxxxxxxx xxxxxx

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

Xxxxxxx:

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

Xxxxxxxxx

Xxxxxx předpis x. 375/2024 Xx. xxxxx xxxxxxxxx xxxx 10.12.2024.

Ke xxx uzávěrky nebyl xxxxx či xxxxxxxxx.

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