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 xxx 5. xxxxxxxx 2024

x xxxxxxxxxx složení xxxxxxxxxx xxxxx xxx pravidelná, xxxxxxxx x xxxxxxxxx xxxxxxxx xxx xxx 2025
&xxxx;

Xxxxxxxxxxxx xxxxxxxxxxxxx xxxxx §80 xxxx. 1 xxxx. e) zákona x. 258/2000 Xx., x xxxxxxx xxxxxxxxx xxxxxx x x xxxxx některých xxxxxxxxxxxxx xxxxxx, ve xxxxx xxxxxxxxxx předpisů, stanoví xx základě xxxxxxxxxx Xxxxxxx xxxxxxxxxx xxxxxx xxxxxxxxx xxxxxxx očkovacích xxxxx xxx pravidelná, xxxxxxxx x xxxxxxxxx xxxxxxxx xxx rok 2025:

1. Xxxxxxxxx xxxxxxx xxxxxxxxxx látek xxx xxxxxxxxxx xxxxxxxx

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

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

Diphtheriae xxxxxxxxxx¹ xx xxxx xxx 30 xxxxxxxxxxxxx xxxxxxxx (IU)

Tetani anatoxinum1 xx xxxx než 40 xxxxxxxxxxxxx xxxxxxxx (XX)

Xxxxxxxx Xxxxxxxxxx pertussis:

Pertussis 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 D xxxxxxxx antigenu

typus 2 (xxxx XXX-1)⁴ 8 X xxxxxxxx antigenu

typus 3 (xxxx Xxxxxxx)⁴ 32 X xxxxxxxx xxxxxxxx

Xxxxxxxxxxx xxxxxxxxxx xxxxx x xxxxxxxxxxxxxxx

(Xxxxxxxxxxxxxxxxxxx phosphas) 10 xxxxxxxxxx

xxxx. xxx xxxxxx. tetanico xxxx xxxxx xxxxxxx xxxxxxxxx 25 mikrogramů

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

² vyrobeno xxxxxxxxxxxxx XXX xxxxxxxxxxx xx kultuře xxxxxxxxxxxx xxxxx (Xxxxxxxxxxxxx cerevisiae)

³ xxxxxxxxxxx xx xxxxxxxxxxx xxxxxxx (XxXX₄) 0,32 xxxxxxxxx Al³⁺

⁴ xxxxxxxxx xx VERO xxxxxxx

XXXX

1xx) xxxxxxxxxxx očkovací xxxxx xxxxx xxxxxxx, dávivému xxxxx (acelulární xxxxx), xxxxxx, dětské přenosné xxxxx (inaktivovaná forma), xxxxxx xxxxxxxxxx B, xxxxxxx xxxxxxxxx Xxxxxxxxxxx xxxxxxxxxx xxx b (XXxXXxxXXXXXX)

Xxxxx xxxxx¹ (0,5 xx) obsahuje:

Diphtheriae xxxxxxxxxx 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 (inaktivovaný)⁵

typus 1 (Xxxxxxx) 29 X jednotek xxxxxxxx⁶

xxxxx 2 (XXX-1) 7 X jednotek xxxxxxxx⁶

xxxxx 3 (Xxxxxxx) 26 X jednotek xxxxxxxx⁶

Xxxxxxxxx xxxxxxxxxxx X antigenum⁷ 10 xxxxxxxxxx

Xxxxxxxxxx influenzae xxxx B polysaccharidum (Xxxxxxxxxxxxxxxxxxx phosphas) 12 xxxxxxxxxx coniugatum xxx xxxxxx proteino 22-36 xxxxxxxxxx

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

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

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

⁴ Nebo xxxxxxxxxxxx xxxxxxxx xxxxxxxxx xxxxxxxxxx imunogenity

⁵ Xxxxxxxxxxx xx Xxxx xxxxxxx

⁶ Xxxx množství xxxxxxxx xxxx úplně stejná xxxx xx, která xxxx xxxxx xxxxxxxxx xxxx 40-8-32 D xxxxxxxx antigenu xxx xxxxx xxxx 1, 2 x 3, xxx měření xxxxx xxxxxxx xxxxxxxxxxxxxx metodou

⁷ xxxxxxxx xxxxxxxxxxxxx XXX xxxxxxxxxxx x xxxxxxxxxxxx xxxxxxx Hansenula polymorpha

NEBO

1ab) Xxxxxxx xxxxx xxxxxxx, xxxxxx, dávivému xxxxx (xxxxxxxxxx xxxxxxxxxx), xxxxxxxxxx X (xXXX), dětské xxxxxxxx xxxxx (xxxxxxxxxxxx) x xxxxxxxxxxx xxxxxxx xxxxx Haemophilus xxxx x (xxxxxxxxxxx)

Xxxxx xxxxx (0,5 ml) xxxxxxxx:

Xxxxxxxxxxx xxxxxxxxxx1 xx xxxx xxx 20 XX⁶

Xxxxxx xxxxxxxxxx1 ne xxxx xxx 40 IU⁶

Antigena 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 B ^2,3 10 xxxxxxxxxx

Xxxxx poliomyelitidis (xxxxxxxxxxx)⁴

Xxxxx 1 (Mahoney) 40 D xxxxxxxx xxxxxxxx⁵

Xxxxx 2 (MEF-1) 8 X xxxxxxxx xxxxxxxx⁵

Xxxxx 3 (Saukett) 32 X xxxxxxxx xxxxxxxx⁵

Xxxxxxxxxxxxxx Xxxxxxxxxx xxxxxxxxxx xxxxx b

(Polyribosylribitoli xxxxxxxx) 3 mikrogramy xxxxxxxxxx xxx xxxxxxxxx xxxxxxxxxxxx xxxxx b² 50 xxxxxxxxxx

¹ xxxxxxxxxxx xx xxxxxxxxxxx xxxxxxx (0,17 xx Al³⁺)

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

³ xxxxxxxx xxxxxxxxxxxxx DNA technologií x kvasinkových buňkách Xxxxxxxxxxxxx xxxxxxxxxx

⁴ pomnoženo xx Vero buňkách

⁵ xxxx xxxxxxxxxxxx xxxxxxxx xxxxxxxx xxxxxxxxx vhodnou xxxxxxxxxxxxxx xxxxxxx

⁶ nebo xxxxxxxxxxxx xxxxxxxx xxxxxxxxx xxxxxxxxxxxx xxxxxxxxxxx

1x) xxxxxxxx xxxxx proti záškrtu, xxxxxxxx kašli (acelulární xxxxx), xxxxxx (XXxX)

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

Xxxxxxxxxxx xxxxxxxxxx* ≥ 30 XX

Xxxxxx xxxxxxxxxx* ≥ 40 XX

Xxxxxxxxx xxxxxxxxxx* (XX) 25 xxxxxxxxxx

Xxxxxxxxx haemaglutininum xxxxxxxxxxxx* (XXX) 25 xxxxxxxxxx

Xxxxxxxxxxx* (69xX) 8 mikrogramů

* xxxxxxxxxxx na xxxxxxxx xxxxxxx celkem: 0,5 xxxxxxxxx

XXXX

1xx) Xxxxxxxx xxxxx xxxxx xxxxxxx, xxxxxx x xxxxxxxx kašli (xxxxxxxxxx) se sníženým xxxxxxx antigenů (Xxxx)

Xxxxx xxxxx (0,5 ml) xxxxxxxx:

Xxxxxxxxxxx anatoxinum - Xxxxxxxxx 2 XX* (2 Xx)

Xxxxxx xxxxxxxxxx - Minimálně 20 XX* (5 Xx)

Xxxxxxxxx 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 xxxxxxxxx spolehlivosti (x = 0,95) xxxxxxxx měřené xxxxx xxxxx xxxxxxxxx v Xxxxxxxxx xxxxxxxx

XXXX

1xx) Očkovací xxxxx proti xxxxxxx, xxxxxx x xxxxxxxx xxxxx (xxxxxxxxxx xxxxxxxxxx) xx xxxxxxxx xxxxxxx xxxxxxxx (Xxxx)

Xxxxx xxxxx (0,5 xx) xxxxxxxx:

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

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

Xxxxxxxxxxx pertussis xxxxxxxx:

Xxxxxxxxx xxxxxxxxxx¹ 8 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxx xxxxxxxxxxxx¹ 8 xxxxxxxxxx

Xxxxxxxxxxx¹ 2,5 xxxxxxxxxx

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

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

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

Xxxxxxxxxxx influenzae xxxxx b xxxx xxxxxxxxxxx 10 xxxxxxxxxx

xxxxxxxxxxx x xxxxxxxxxx xxxxxxxx xxxx xxxxxxxxxxx xxxxxxx xxxxxxxxx 25 xxxxxxxxxx

1x) xxxxxxxx látka xxxxx xxxxxx:

Xxxxx dávka xxxxxxxx:

Xxxxxx xxxxxxxxxx - min. 40 xxxxxxxxxxxxx jednotek

1e) xxxxxxxx xxxxx xxxxx xxxxxx hepatitidč B x xxxxxx xxxxxxx:

Xxxxx xxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx X - 10 mikrogramů

1f) xxxxxxxx xxxxx xxxxx virové xxxxxxxxxx X x xxxxxxx xxxxxxx

Xxxxx xxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx X - 20 xxxxxxxxxx

1x) očkovací xxxxx xxxxx xxxxxxxxxx, příušnicím x zarděnkám:

dávka rekonstituované xxxxxxx (0,5 xx) xxxxxxxx:

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

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

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

¹ pomnoženo xx xxxxxxx xxxxxxxx embryí

² xxxxxxxxx xx xxxxxxxx xxxxxxxxxxx xxxxxxx (MRC-5)

³ 50% infekční xxxxx xxxxxxx xxxxxxx

XXXX

1xx) očkovací xxxxx xxxxx xxxxxxxxxx, xxxxxxxxxx a xxxxxxxxx

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

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

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

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

* 50% xxxxxxxx xxxxx xxxxxxx xxxxxxx

¹ vyrobeno xx xxxxxxx xxxxxxxx xxxxxx.

² vyrobeno xx xxxxxxxx diploidních xxxxxxxx XX-38 fibroblastech

1h) očkovací xxxxx xxxxx dětské xxxxxxxx xxxxx x xxxxxxxxxxxx formě:

Jedna xxxxx (0,5 xx) xxxxxxxx:

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

Xxxxx xxxxxxxxxxxxx inactivatum xxxxx 2 (MEF-1) ... 7 xxxxxxxxxxx X jednotek**

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

* Xxxxxxxxxxx xx XXXX buňkách

** Tato xxxxxxxx xxxxxxxx xxxx xxxxx stejná jako xx, xxxxx xxxx xxxxx xxxxxxxxx xxxx 40-8-32 D xxxxxxxx xxxxxxxx xxx xxxxx xxxx 1, 2 x 3, xxx xxxxxx xxxxx vhodnou xxxxxxxxxxxxxx metodou

1ch) xxxxxxxxxxx xxxxxxxx látka xxxxx xxxxxxxxxxxxx xxxxxxxx

Xxxxx xxxxx (0,5 ml) xxxxxxxx:

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

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

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

xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Streptococcus xxxxxxxxxx xxxxxxxx 5 ^1,2 2,2 µg

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

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

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

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

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

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

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

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

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

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

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

xxxxxxxxxxxx xxxxxxxx (pneumokoka) 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 (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 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 fosforečnan hlinitý (0,125 xx hliníku xx xxxxx)

XXXX

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

1xxxx) xxxxxxxxxxx xxxxxxxx látka xxxxxxxx:

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

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 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 xxxxxxxxxx

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

Streptococci xxxxxxxxxx xxxxxxxx 18C^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 serotypi 22X^1,2 xxxxxxxxxxxxxxx 2,0 mikrogramů

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

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

¹ Xxxxxxxxxx x proteinovým xxxxxxx XXX₁₉₇, XXX₁₉₇ xx xxxxxxxxx mutace xxxxxxxxxxxx toxinu (pocházejícího x Xxxxxxxxxxxxxxx xxxxxxxxxxx X7) xxxxxxxxxxxxx xxxxxxxxxxxxx x Xxxxxxxxxxx xxxxxxxxxxx

² Xxxxxxxxxx xx xxxxxxxx xxxxxxxxxxx xxxxxxx

X

1xxxx) xxxx xxxxxxxxxxx očkovací xxxxx xxxxxxxx:

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

XXXX

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

1xxxx) xxxxxxxxxxx očkovací xxxxx obsahuje:

Streptococci xxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 1¹ 2,2µx

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 3¹ 2,2 µx

Xxxxxxxxxxxx pneumoniae polysaccharidum xxxxxxxxx 4¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum xxxxxxxxx 5¹ 2,2 µx

Xxxxxxxxxxxx pneumoniae polysaccharidum xxxxxxxxx 6X¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 6B¹ 4,4 µx

Xxxxxxxxxxxx pneumoniae polysaccharidum xxxxxxxxx 7F¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 9X¹ 2,2 µx

Xxxxxxxxxxxx pneumoniae polysaccharidum xxxxxxxxx 14¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 18X¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum xxxxxxxxx 19A¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 19X¹ 2,2 µx

Xxxxxxxxxxxx pneumoniae polysaccharidum xxxxxxxxx 23X¹ 2,2 µx

¹ Xxxxxxxxxx s xxxxxx proteinem CRM₁₉₇ x adsorbován na xxxxxxxxxxx hlinitý (0,125 xx xxxxxxx)

X

1xxxx) póly xxxxxxxxxxx očkovací látka xxxxxxxx:

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

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

Xxxxx xxxxx (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx anatoxinum¹ - xx méně xxx 2 xxxxxxxxxxx xxxxxxxx (XX) (2,5 Lf)

Tetani xxxxxxxxxx¹-&xxxx; xx xxxx xxx 20 xxxxxxxxxxxxx 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 (xxxx Xxxxxxx)² 40 X xxxxxxxx xxxxxxxx

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

typus 3 (kmen Xxxxxxx)² 32 D xxxxxxxx xxxxxxxx

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

² xxxxxxxxx xx XXXX buňkách

NEBO

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

Xxxxx dávka (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx xxxxxxxxxx xxxxxxxxx 2 XX¹ (2 Xx)

Xxxxxx xxxxxxxxxx xxxxxxxxx 20 XX¹ (5 Lf)

Pertusové 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 (Xxxxxxx) 29 X jednotek xxxxxxxx³

xxxxx 2 (MEF1) 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 hranice intervalu xxxxxxxxxxxxx (x = 0,95) xxxxxxxx měřené xxxxx xxxxx xxxxxxxxx x Xxxxxxxxx xxxxxxxx

² Xxxxxxxxxxx na Xxxx xxxxxxx

³ Xxxx xxxxxxxx xxxxxxxx xxxx xxxxx xxxxxx xxxx xx, xxxxx xxxx xxxxx xxxxxxxxx jako 40-8-32 X xxxxxxxx xxxxxxxx xxx xxxxx typu 1, 2 a 3, xxx xxxxxx xxxxx vhodnou xxxxxxxxxxxxxx xxxxxxx

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

** Xxxxxxxxxxx xx Xxxx xxxxxxx.

1x) xxxxxxxx xxxxx xxxxx xxxxxxxxxxx (BCG xxxxxxx)

1x) xxxxxxxx xxxxx xxxxx xxxxxx xxxxxxxxxx X xxx osoby xxxxxxxx xx xxxxxxxxxxxx xxxxxxxx:

Xxxxx xxxxx (0,5 xx) xxxxxxx xxxxxxxx:

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

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

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

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

2. Xxxxxxxxx xxxxxxx xxxxxxxxxx xxxxx pro xxxxxxxx xxxxxxxx

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

Xxxxx xxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx X - 20 xxxxxxxxxx

2x) xxxxxxxx xxxxx xxxxx xxxxxxxxx

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

Xxxxx xxxxx xxxxxxxx:

Xxxxxxxxx A xxxxx xxxxxxxxxxx

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

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

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

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

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

¹ xxxxxxxxx na xxxxxxx xxxxxxxx xxxxxx

² xxxxxxxxx xx xxxxxxxx diploidních xxxxxxx (XXX-5)

³ 50% xxxxxxxx xxxxx xxxxxxx xxxxxxx

XXXX

2xx) xxxxxxxx xxxxx xxxxx xxxxxxxxxx, xxxxxxxxxx x xxxxxxxxx

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

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

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

Xxxxx rubeolae² xxxxx xxxxxxxxxx (xxxx Xxxxxx XX 27/3) xx xxxx xxx 1x10³ XXXX₅₀*

* 50% xxxxxxxx xxxxx xxxxxxx xxxxxxx

¹ xxxxxxxx xx xxxxxxx kuřecích embryí

² xxxxxxxx na lidských xxxxxxxxxxx buňkách XX-38 xxxxxxxxxxxxx.

3. Xxxxxxxxx složení xxxxxxxxxx xxxxx xxx xxxxxxxxx xxxxxxxx

3x) xxxxxxxx xxxxx proti virové xxxxxxxxxx X ve xxxxxxx xxx xxxxxxx:

Xxxxx xxxxxxxxx A xxxxxxxxxxx

3x) xxxxxxxx xxxxx xxxxx xxxxxx xxxxxxxxxx A xx formuli pro xxxx:

Xxxxx xxxxxxxxx X xxxxxxxxxxx

3x) očkovací látka xxxxx xxxxxxxxxx, xxxxxxxxxx x zarděnkám:

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

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

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

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

¹ xxxxxxxxx xx buňkách xxxxxxxx xxxxxx

² xxxxxxxxx xx xxxxxxxx diploidních xxxxxxx (XXX-5)

³ 50% infekční xxxxx xxxxxxx xxxxxxx

XXXX

3xx) xxxxxxxx látka proti xxxxxxxxxx, xxxxxxxxxx x xxxxxxxxx

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

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

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

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

* 50% infekční xxxxx buněčné xxxxxxx

¹ xxxxxxxx na xxxxxxx xxxxxxxx xxxxxx

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

Xxxxxxx:

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

Xxxxxxxxx

Xxxxxx xxxxxxx č. 375/2024 Sb. nabyl xxxxxxxxx dnem 10.12.2024.

Xx xxx xxxxxxxx nebyl xxxxx xx xxxxxxxxx.

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