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 složení xxxxxxxxxx xxxxx pro xxxxxxxxxx, xxxxxxxx a xxxxxxxxx xxxxxxxx pro xxx 2025
&xxxx;

Xxxxxxxxxxxx xxxxxxxxxxxxx xxxxx §80 xxxx. 1 xxxx. e) zákona x. 258/2000 Sb., x xxxxxxx xxxxxxxxx xxxxxx a x xxxxx xxxxxxxxx xxxxxxxxxxxxx xxxxxx, xx znění xxxxxxxxxx předpisů, stanoví xx xxxxxxx xxxxxxxxxx Xxxxxxx imunizační komise xxxxxxxxx xxxxxxx xxxxxxxxxx xxxxx xxx pravidelná, xxxxxxxx a xxxxxxxxx xxxxxxxx xxx rok 2025:

1. Xxxxxxxxx složení xxxxxxxxxx látek xxx xxxxxxxxxx xxxxxxxx

1x) kombinovaná xxxxxxxx látka proti xxxxxxx, dávivému xxxxx (xxxxxxxxxx xxxxx), tetanu, xxxxxx xxxxxxxx xxxxx (xxxxxxxxxxxx forma), xxxxxx xxxxxxxxxx X, xxxxxxx xxxxxxxxx Xxxxxxxxxxx xxxxxxxxxx xxx x (DTaPHibVHBIPV)

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

Xxxxxxxxxxx xxxxxxxxxx¹ xx xxxx xxx 30 xxxxxxxxxxxxx xxxxxxxx (XX)

Xxxxxx xxxxxxxxxx1 xx méně než 40 mezinárodních xxxxxxxx (XX)

Xxxxxxxx Xxxxxxxxxx pertussis:

Pertussis xxxxxxxxxx (XX)¹ 25 xxxxxxxxxx

Xxxxxxxxx haemagglutininum xxxxxxxxxxxx (XXX)¹ 25 xxxxxxxxxx

Xxxxxxxxxxx (XXX)¹ 8 xxxxxxxxxx

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

Xxxxx xxxxxxxxxxxxxxx inactivatum (XXX)

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

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

xxxxx 3 (xxxx Saukett)⁴ 32 X jednotek xxxxxxxx

Xxxxxxxxxxx xxxxxxxxxx xxxxx x polysaccharidum

(Polyribosylribitoli xxxxxxxx) 10 mikrogramů

conj. xxx xxxxxx. tetanico jako xxxxx protein přibližně 25 xxxxxxxxxx

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

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

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

⁴ xxxxxxxxx xx VERO xxxxxxx

XXXX

1xx) xxxxxxxxxxx očkovací xxxxx xxxxx xxxxxxx, dávivému xxxxx (xxxxxxxxxx xxxxx), xxxxxx, xxxxxx xxxxxxxx xxxxx (xxxxxxxxxxxx xxxxx), xxxxxx xxxxxxxxxx B, xxxxxxx vyvolaným Xxxxxxxxxxx xxxxxxxxxx typ x (XXxXXxxXXXXXX)

Xxxxx dávka¹ (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx xxxxxxxxxx xx méně xxx 20 mezinárodních xxxxxxxx (XX)^2,4 (30 Xx)

Xxxxxx xxxxxxxxxx ne xxxx xxx 40 xxxxxxxxxxxxx xxxxxxxx (IU)^3,4 (10 Xx)

Xxxxxxxx Xxxxxxxxxx xxxxxxxxx

Xxxxxxxxx xxxxxxxxxx 25 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxxxx xxxxxxxxxxxx 25 xxxxxxxxxx

Xxxxx Xxxxxxxxxxxxxxx (inaktivovaný)⁵

typus 1 (Xxxxxxx) 29 X xxxxxxxx xxxxxxxx⁶

xxxxx 2 (XXX-1) 7 X jednotek antigenu⁶

typus 3 (Saukett) 26 X jednotek xxxxxxxx⁶

Xxxxxxxxx xxxxxxxxxxx X xxxxxxxxx⁷ 10 mikrogramů

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

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

² Xxxx spodní xxx xxxxxxxxxxxxx (x = 0,95) a ne 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 xxxxxx xxxx xx, xxxxx xxxx xxxxx xxxxxxxxx xxxx 40-8-32 X xxxxxxxx xxxxxxxx pro xxxxx xxxx 1, 2 x 3, xxx xxxxxx jinou xxxxxxx xxxxxxxxxxxxxx xxxxxxx

⁷ xxxxxxxx xxxxxxxxxxxxx XXX xxxxxxxxxxx x xxxxxxxxxxxx xxxxxxx Xxxxxxxxx polymorpha

NEBO

1ab) Xxxxxxx xxxxx xxxxxxx, xxxxxx, xxxxxxxx xxxxx (xxxxxxxxxx komponenta), hepatitidě X (rDNA), xxxxxx xxxxxxxx xxxxx (xxxxxxxxxxxx) x konjugovaná vakcína xxxxx Xxxxxxxxxxx typu x (adsorbovaná)

Jedna xxxxx (0,5 xx) obsahuje:

Diphtheriae xxxxxxxxxx1 xx méně xxx 20 IU⁶

Tetani xxxxxxxxxx1 ne xxxx xxx 40 IU⁶

Antigena Xxxxxxxxxxx xxxxxxxx¹

Xxxxxxxxx xxxxxxxxxx (XX) 20 xxxxxxxxxx

Xxxxxxxxxxxxxxx xxxxxxxxxxxx (XXX) 20 xxxxxxxxxx

Xxxxxxxxxxx (PRN) 3 xxxxxxxxxx

Xxxxxxxx typi 2 xx 3 (XXX) 5 mikrogramů

Antigenum xxxxxxxxx xxxxxxxxxxx B ^2,3 10 xxxxxxxxxx

Xxxxx xxxxxxxxxxxxxxx (xxxxxxxxxxx)⁴

Xxxxx 1 (Xxxxxxx) 40 X xxxxxxxx xxxxxxxx⁵

Xxxxx 2 (MEF-1) 8 X xxxxxxxx xxxxxxxx⁵

Xxxxx 3 (Xxxxxxx) 32 X jednotek xxxxxxxx⁵

Xxxxxxxxxxxxxx Xxxxxxxxxx xxxxxxxxxx xxxxx x

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

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

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

³ xxxxxxxx xxxxxxxxxxxxx XXX technologií x kvasinkových buňkách Xxxxxxxxxxxxx xxxxxxxxxx

⁴ xxxxxxxxx xx Vero xxxxxxx

⁵ xxxx xxxxxxxxxxxx xxxxxxxx xxxxxxxx xxxxxxxxx vhodnou xxxxxxxxxxxxxx xxxxxxx

⁶ nebo xxxxxxxxxxxx xxxxxxxx xxxxxxxxx xxxxxxxxxxxx imunogenity

1b) xxxxxxxx xxxxx xxxxx xxxxxxx, xxxxxxxx xxxxx (xxxxxxxxxx xxxxx), tetanu (XXxX)

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

Xxxxxxxxxxx anatoxinum* ≥ 30 IU

Tetani xxxxxxxxxx* ≥ 40 IU

Pertussis xxxxxxxxxx* (XX) 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 xxxxxxx, xxxxxx x xxxxxxxx xxxxx (xxxxxxxxxx) se xxxxxxxx xxxxxxx xxxxxxxx (Tdap)

Jedna xxxxx (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx anatoxinum - Xxxxxxxxx 2 XX* (2 Xx)

Xxxxxx xxxxxxxxxx - Xxxxxxxxx 20 XX* (5 Lf)

Pertusové xxxxxxxx

Xxxxxxxxx xxxxxxxxxx - 2,5 mikrogramů

Haemagglutinum filamentosum - 5 mikrogramů

Pertactinum - 3 xxxxxxxxxx

Xxxxxxxx, xxxx 2 xx 3 - 5 xxxxxxxxxx

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

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

NEBO

1bb) Xxxxxxxx xxxxx proti xxxxxxx, xxxxxx a xxxxxxxx xxxxx (xxxxxxxxxx xxxxxxxxxx) xx xxxxxxxx xxxxxxx xxxxxxxx (Tdap)

Jedna xxxxx (0,5 xx) xxxxxxxx:

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

Xxxxxx xxxxxxxxxx¹ xx xxxx než 20 xxxxxxxxxxxxx xxxxxxxx (IU) (5 Lf)

Bordetellae xxxxxxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxxx¹ 8 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxx xxxxxxxxxxxx¹ 8 xxxxxxxxxx

Xxxxxxxxxxx¹ 2,5 xxxxxxxxxx

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

1x) očkovací xxxxx proti nákazám xxxxxxxxx Haemophilus xxxxxxxxxx xxx x:

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

Xxxxxxxxxxx influenzae xxxxx x póly xxxxxxxxxxx 10 xxxxxxxxxx

xxxxxxxxxxx x tetanickým xxxxxxxx xxxx xxxxxxxxxxx xxxxxxx xxxxxxxxx 25 mikrogramů

1d) xxxxxxxx xxxxx xxxxx xxxxxx:

Xxxxx dávka xxxxxxxx:

Xxxxxx xxxxxxxxxx - min. 40 mezinárodních jednotek

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

Xxxxx xxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx B - 10 xxxxxxxxxx

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

Jedna xxxxx xxxxxxxx:

Xxxxxxxxx tegiminis xxxxxxxxxxx X - 20 xxxxxxxxxx

1x) očkovací látka xxxxx spalničkám, xxxxxxxxxx x zarděnkám:

dávka xxxxxxxxxxxxxxx xxxxxxx (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx virus attenuatum¹ (Xxxxxxx) xxx. 10^3,0 xxxxxxxx xxxxx xxx xxxxxxxx kulturu₅₀³

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

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

¹ xxxxxxxxx xx xxxxxxx kuřecích embryí

² xxxxxxxxx na lidských xxxxxxxxxxx buňkách (MRC-5)

³ 50% infekční dávka xxxxxxx xxxxxxx

XXXX

1xx) očkovací xxxxx xxxxx xxxxxxxxxx, xxxxxxxxxx x xxxxxxxxx

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

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

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

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

* 50% infekční xxxxx xxxxxxx kultury

¹ vyrobeno xx buňkách kuřecích xxxxxx.

² xxxxxxxx na xxxxxxxx xxxxxxxxxxx xxxxxxxx XX-38 xxxxxxxxxxxxx

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

Xxxxx xxxxx (0,5 xx) obsahuje:

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

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

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

* Xxxxxxxxxxx xx XXXX xxxxxxx

** Xxxx xxxxxxxx antigenu jsou xxxxx stejná xxxx xx, která xxxx xxxxx xxxxxxxxx xxxx 40-8-32 D jednotek xxxxxxxx xxx xxxxx xxxx 1, 2 x 3, xxx xxxxxx xxxxx xxxxxxx xxxxxxxxxxxxxx xxxxxxx

1xx) konjugovaná xxxxxxxx xxxxx xxxxx xxxxxxxxxxxxx infekcím

Jedna xxxxx (0,5 xx) xxxxxxxx:

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

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

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

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

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

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

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

xxxxxxxxxxxx xxxxxxxx (pneumokoka) Streptococcus xxxxxxxxxx sérotypu 8 ^1,2 2,2 µg

polysacharid xxxxxxxx (pneumokoka) Streptococcus xxxxxxxxxx xxxxxxxx 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 xxxxxxxxxx xxxxxxxx 12X ^1,2 2,2 µx

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

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

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

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

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

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

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

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

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

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

XXXX

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

1xxxx) 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 serotypi 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 xxxxxxxxxx

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

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

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

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

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

Streptococci xxxxxxxxxx xxxxxxxx 19X^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 33X^1,2 xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx

¹ Xxxxxxxxxx x xxxxxxxxxxx xxxxxxx CRM₁₉₇, XXX₁₉₇ xx xxxxxxxxx mutace xxxxxxxxxxxx xxxxxx (xxxxxxxxxxxxx x Xxxxxxxxxxxxxxx xxxxxxxxxxx X7) rekombinantně xxxxxxxxxxxxx x Pseudomonas xxxxxxxxxxx

² Xxxxxxxxxx na xxxxxxxx xxxxxxxxxxx xxxxxxx

X

1xxxx) xxxx xxxxxxxxxxx očkovací xxxxx xxxxxxxx:

xx 25 xxxxxxxxxxxx xxxxxxxxxxxxx 23 pneumokokových 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

XXXX

1xxx) xxxxxxxx xxxxx xxxxx pneumokokovým xxxxxxxx xxxxxxxxx x sekvenčním xxxxxxxx:

1xxxx) xxxxxxxxxxx xxxxxxxx xxxxx obsahuje:

Streptococci pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 1¹ 2,2µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx 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 6A¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 6X¹ 4,4 µx

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 7F¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 9X¹ 2,2 µx

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 14¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum xxxxxxxxx 18X¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 19X¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 19X¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 23X¹ 2,2 µx

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

A

1chbb) xxxx xxxxxxxxxxx xxxxxxxx látka xxxxxxxx:

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

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

Xxxxx xxxxx (0,5 xx) xxxxxxxx:

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

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

Xxxxxxxxxxx pertussis antigena:

Pertussis xxxxxxxxxx¹ - 8 xxxxxxxxxx

Xxxxxxxxx haemagglutinum filamentosum¹ - 8 mikrogramů

Pertaktin1 2,5 xxxxxxxxxx

Xxxxx poliomyelitidis xxxxxxxxxxx:

xxxxx 1 (xxxx Xxxxxxx)² 40 D xxxxxxxx xxxxxxxx

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

xxxxx 3 (xxxx Xxxxxxx)² 32 X xxxxxxxx xxxxxxxx

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

² xxxxxxxxx xx VERO xxxxxxx

XXXX

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

Jedna dávka (0,5 ml) xxxxxxxx:

Xxxxxxxxxxx xxxxxxxxxx xxxxxxxxx 2 XX¹ (2 Lf)

Tetani xxxxxxxxxx xxxxxxxxx 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 jednotek xxxxxxxx³

xxxxx 2 (MEF1) 7 X xxxxxxxx xxxxxxxx³

xxxxx 3 (Saukett) 26 X jednotek antigenu³

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

¹ Xxxx xxxxxx xxxxxxx intervalu xxxxxxxxxxxxx (x = 0,95) xxxxxxxx xxxxxx xxxxx testu xxxxxxxxx x Xxxxxxxxx lékopisu

² Xxxxxxxxxxx na Vero xxxxxxx

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

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

** Xxxxxxxxxxx xx Xxxx xxxxxxx.

1x) xxxxxxxx xxxxx xxxxx xxxxxxxxxxx (XXX xxxxxxx)

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

Xxxxx xxxxx (0,5 ml) xxxxxxx obsahuje:

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

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

² xxxxxxxxxxx xx xxxxxxxxxxx xxxxxxx (xxxxxx 0,5 xxxxxxxxx Al³⁺)

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

2. Xxxxxxxxx xxxxxxx očkovacích xxxxx pro xxxxxxxx xxxxxxxx

2x) očkovací látka xxxxx virové hepatitidě X ve xxxxxxx xxx dospělé:

Jedna dávka xxxxxxxx:

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx X - 20 xxxxxxxxxx

2x) xxxxxxxx xxxxx xxxxx xxxxxxxxx

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

Xxxxx xxxxx xxxxxxxx:

Xxxxxxxxx X xxxxx xxxxxxxxxxx

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

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

Morbillorum xxxxx xxxxxxxxxx¹ (Xxxxxxx) xxx. 10^3,0 infekční xxxxx pro buněčnou xxxxxxx₅₀³

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

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

¹ xxxxxxxxx xx xxxxxxx xxxxxxxx xxxxxx

² pomnoženo xx xxxxxxxx diploidních xxxxxxx (XXX-5)

³ 50% xxxxxxxx xxxxx tkáňové xxxxxxx

XXXX

2xx) xxxxxxxx xxxxx xxxxx xxxxxxxxxx, příušnicím x xxxxxxxxx

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

Xxxxx xxxxxxxxxxx¹ xxxxx attenuatum (xxxx Xxxxxx’ Xxxxxxxxx) xx xxxx než 1x10³ XXXX₅₀*

Xxxxx parotitidis¹ xxxxx xxxxxxxxxx (xxxx Xxxxx Xxxx™, xxxxxxx X) xx xxxx xxx 12,5x10³ XXXX₅₀*

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

* 50% xxxxxxxx xxxxx xxxxxxx xxxxxxx

¹ vyrobeno xx xxxxxxx xxxxxxxx embryí

² xxxxxxxx xx xxxxxxxx xxxxxxxxxxx xxxxxxx WI-38 xxxxxxxxxxxxx.

3. Xxxxxxxxx xxxxxxx xxxxxxxxxx xxxxx xxx xxxxxxxxx očkování

3a) xxxxxxxx xxxxx proti virové xxxxxxxxxx X xx xxxxxxx pro dospělé:

Virus xxxxxxxxx X inactivatum

3b) xxxxxxxx látka xxxxx xxxxxx xxxxxxxxxx A xx xxxxxxx pro xxxx:

Xxxxx xxxxxxxxx X xxxxxxxxxxx

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

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

Morbillorum virus xxxxxxxxxx¹ (Xxxxxxx) min. 10^3,0 xxxxxxxx dávka xxx xxxxxxxx kulturu₅₀³

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

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

¹ xxxxxxxxx xx buňkách kuřecích xxxxxx

² xxxxxxxxx xx xxxxxxxx xxxxxxxxxxx buňkách (XXX-5)

³ 50% xxxxxxxx xxxxx xxxxxxx xxxxxxx

XXXX

3xx) xxxxxxxx xxxxx xxxxx xxxxxxxxxx, xxxxxxxxxx a xxxxxxxxx

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

Xxxxx morbillorum¹ xxxxx xxxxxxxxxx (kmen Xxxxxx’ Xxxxxxxxx) xx xxxx xxx 1x10³ CCID₅₀*

Virus xxxxxxxxxxx¹ xxxxx xxxxxxxxxx (xxxx Jeryl Xxxx™, xxxxxxx X) xx xxxx než 12,5x10³ XXXX₅₀*

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

* 50% xxxxxxxx xxxxx buněčné xxxxxxx

¹ xxxxxxxx xx buňkách xxxxxxxx embryí

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

Xxxxxxx:

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

Xxxxxxxxx

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

Ke xxx xxxxxxxx xxxxx xxxxx xx xxxxxxxxx.

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