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

Xxxxxxxxxxxx xxxxxxxxxxxxx podle §80 xxxx. 1 xxxx. e) zákona x. 258/2000 Sb., x ochraně xxxxxxxxx xxxxxx a x xxxxx některých xxxxxxxxxxxxx xxxxxx, xx znění xxxxxxxxxx předpisů, stanoví xx xxxxxxx xxxxxxxxxx Xxxxxxx xxxxxxxxxx komise xxxxxxxxx složení xxxxxxxxxx xxxxx pro xxxxxxxxxx, xxxxxxxx x mimořádná xxxxxxxx xxx xxx 2025:

1. Antigenní xxxxxxx xxxxxxxxxx látek xxx xxxxxxxxxx očkování

1a) xxxxxxxxxxx xxxxxxxx látka xxxxx xxxxxxx, xxxxxxxx kašli (xxxxxxxxxx forma), tetanu, xxxxxx xxxxxxxx obrně (xxxxxxxxxxxx xxxxx), virové xxxxxxxxxx X, nákazám xxxxxxxxx Xxxxxxxxxxx xxxxxxxxxx xxx b (DTaPHibVHBIPV)

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

Xxxxxxxxxxx xxxxxxxxxx¹ ne xxxx xxx 30 mezinárodních xxxxxxxx (XX)

Xxxxxx anatoxinum1 xx méně než 40 mezinárodních jednotek (XX)

Xxxxxxxx Xxxxxxxxxx xxxxxxxxx:

Xxxxxxxxx xxxxxxxxxx (XX)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 inactivatum (XXX)

xx xxx 1 (kmen Xxxxxxx)⁴ 40 D xxxxxxxx xxxxxxxx

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

typus 3 (xxxx Xxxxxxx)⁴ 32 X jednotek xxxxxxxx

Xxxxxxxxxxx xxxxxxxxxx xxxxx x polysaccharidum

(Polyribosylribitoli xxxxxxxx) 10 xxxxxxxxxx

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

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

² xxxxxxxx xxxxxxxxxxxxx XXX technologií xx xxxxxxx xxxxxxxxxxxx xxxxx (Xxxxxxxxxxxxx cerevisiae)

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

⁴ xxxxxxxxx xx VERO xxxxxxx

XXXX

1xx) xxxxxxxxxxx očkovací látka xxxxx záškrtu, dávivému xxxxx (xxxxxxxxxx xxxxx), xxxxxx, xxxxxx xxxxxxxx xxxxx (xxxxxxxxxxxx forma), xxxxxx xxxxxxxxxx X, xxxxxxx vyvolaným Xxxxxxxxxxx xxxxxxxxxx xxx x (XXxXXxxXXXXXX)

Xxxxx dávka¹ (0,5 xx) xxxxxxxx:

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

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

Xxxxxxxx Bordetelly xxxxxxxxx

Xxxxxxxxx xxxxxxxxxx 25 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxxxx filamentosum 25 xxxxxxxxxx

Xxxxx Poliomyelitidis (xxxxxxxxxxxx)⁵

xxxxx 1 (Xxxxxxx) 29 X xxxxxxxx antigenu⁶

typus 2 (MEF-1) 7 X xxxxxxxx xxxxxxxx⁶

xxxxx 3 (Xxxxxxx) 26 X xxxxxxxx xxxxxxxx⁶

Xxxxxxxxx xxxxxxxxxxx X xxxxxxxxx⁷ 10 xxxxxxxxxx

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

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

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

³ Jako spodní xxx spolehlivosti (x = 0,95)

⁴ Nebo xxxxxxxxxxxx xxxxxxxx xxxxxxxxx xxxxxxxxxx xxxxxxxxxxx

⁵ Kultivováno xx Xxxx buňkách

⁶ Xxxx xxxxxxxx antigenu xxxx úplně xxxxxx xxxx ta, která xxxx xxxxx vyjádřená xxxx 40-8-32 X xxxxxxxx xxxxxxxx xxx xxxxx xxxx 1, 2 a 3, xxx xxxxxx xxxxx xxxxxxx imunochemickou metodou

⁷ xxxxxxxx xxxxxxxxxxxxx XXX xxxxxxxxxxx x xxxxxxxxxxxx xxxxxxx Xxxxxxxxx xxxxxxxxxx

XXXX

1xx) Xxxxxxx xxxxx xxxxxxx, xxxxxx, xxxxxxxx xxxxx (xxxxxxxxxx xxxxxxxxxx), hepatitidě X (xXXX), xxxxxx xxxxxxxx obrně (inaktivovaná) x xxxxxxxxxxx xxxxxxx xxxxx Xxxxxxxxxxx xxxx x (xxxxxxxxxxx)

Xxxxx dávka (0,5 xx) obsahuje:

Diphtheriae xxxxxxxxxx1 ne xxxx xxx 20 XX⁶

Xxxxxx xxxxxxxxxx1 ne xxxx xxx 40 XX⁶

Xxxxxxxx Xxxxxxxxxxx pertusis¹

Pertussis xxxxxxxxxx (XX) 20 xxxxxxxxxx

Xxxxxxxxxxxxxxx xxxxxxxxxxxx (XXX) 20 xxxxxxxxxx

Xxxxxxxxxxx (PRN) 3 xxxxxxxxxx

Xxxxxxxx xxxx 2 xx 3 (FIM) 5 mikrogramů

Antigenum xxxxxxxxx xxxxxxxxxxx X ^2,3 10 mikrogramů

Virus xxxxxxxxxxxxxxx (xxxxxxxxxxx)⁴

Xxxxx 1 (Xxxxxxx) 40 X xxxxxxxx xxxxxxxx⁵

Xxxxx 2 (MEF-1) 8 X xxxxxxxx xxxxxxxx⁵

Xxxxx 3 (Xxxxxxx) 32 D xxxxxxxx xxxxxxxx⁵

Xxxxxxxxxxxxxx Xxxxxxxxxx xxxxxxxxxx xxxxx x

(Xxxxxxxxxxxxxxxxxxx xxxxxxxx) 3 mikrogramy xxxxxxxxxx xxx proteinům xxxxxxxxxxxx xxxxx b² 50 xxxxxxxxxx

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

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

³ xxxxxxxx xxxxxxxxxxxxx DNA technologií x xxxxxxxxxxxx buňkách Xxxxxxxxxxxxx cerevisiae

⁴ pomnoženo xx Xxxx buňkách

⁵ xxxx xxxxxxxxxxxx množství xxxxxxxx xxxxxxxxx xxxxxxx xxxxxxxxxxxxxx xxxxxxx

⁶ xxxx xxxxxxxxxxxx xxxxxxxx xxxxxxxxx xxxxxxxxxxxx xxxxxxxxxxx

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

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

Xxxxxxxxxxx xxxxxxxxxx* ≥ 30 XX

Xxxxxx anatoxinum* ≥ 40 IU

Pertussis xxxxxxxxxx* (PT) 25 xxxxxxxxxx

Xxxxxxxxx haemaglutininum filamentosum* (XXX) 25 xxxxxxxxxx

Xxxxxxxxxxx* (69xX) 8 xxxxxxxxxx

* xxxxxxxxxxx xx hydroxid xxxxxxx xxxxxx: 0,5 xxxxxxxxx

XXXX

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

Jedna xxxxx (0,5 ml) xxxxxxxx:

Xxxxxxxxxxx xxxxxxxxxx - Xxxxxxxxx 2 XX* (2 Xx)

Xxxxxx xxxxxxxxxx - 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 xx xxxxxxxxxxx xxxxxxx - 1,5 xx (0,33 mg xxxxxxx)

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

XXXX

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

Xxxxx xxxxx (0,5 xx) xxxxxxxx:

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

Xxxxxx xxxxxxxxxx¹ xx xxxx xxx 20 xxxxxxxxxxxxx xxxxxxxx (XX) (5 Xx)

Xxxxxxxxxxx xxxxxxxxx xxxxxxxx:

Xxxxxxxxx anatoxinum¹ 8 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxx xxxxxxxxxxxx¹ 8 mikrogramů

Pertactinum¹ 2,5 xxxxxxxxxx

¹ xxxxxxxxxxx xx xxxxxxxxxxx hydroxid hlinitý (X1(XX)₃) 0,3 xxxxxxxxx Xx³⁺ x fosforečnan xxxxxxx (XxXX₄) 0,2 xxxxxxxxx Xx³⁺

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

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

Haemophilus xxxxxxxxxx xxxxx x póly xxxxxxxxxxx 10 xxxxxxxxxx

xxxxxxxxxxx x xxxxxxxxxx xxxxxxxx xxxx bílkovinným nosičem xxxxxxxxx 25 mikrogramů

1d) xxxxxxxx xxxxx proti xxxxxx:

Xxxxx xxxxx xxxxxxxx:

Xxxxxx xxxxxxxxxx - min. 40 xxxxxxxxxxxxx xxxxxxxx

1x) xxxxxxxx xxxxx xxxxx xxxxxx hepatitidč X x dětské xxxxxxx:

Xxxxx xxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx B - 10 xxxxxxxxxx

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

Jedna xxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx X - 20 xxxxxxxxxx

1x) xxxxxxxx látka xxxxx spalničkám, příušnicím x xxxxxxxxx:

xxxxx xxxxxxxxxxxxxxx xxxxxxx (0,5 ml) xxxxxxxx:

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

¹ xxxxxxxxx xx xxxxxxx xxxxxxxx xxxxxx

² xxxxxxxxx xx lidských xxxxxxxxxxx xxxxxxx (MRC-5)

³ 50% xxxxxxxx xxxxx xxxxxxx xxxxxxx

XXXX

1xx) xxxxxxxx xxxxx proti xxxxxxxxxx, xxxxxxxxxx x xxxxxxxxx

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

Xxxxx xxxxxxxxxxx¹ xxxxx xxxxxxxxxx (xxxx Enders’ Xxxxxxxxx) xx xxxx než 1x10³ XXXX₅₀*

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

Xxxxx xxxxxxxx² xxxxx xxxxxxxxxx (xxxx Xxxxxx RA 27/3) ne xxxx xxx 1x10³ CCID₅₀*

* 50% xxxxxxxx xxxxx xxxxxxx xxxxxxx

¹ xxxxxxxx xx xxxxxxx xxxxxxxx xxxxxx.

² xxxxxxxx xx xxxxxxxx xxxxxxxxxxx xxxxxxxx XX-38 fibroblastech

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

Xxxxx xxxxx (0,5 xx) xxxxxxxx:

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

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

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

* Xxxxxxxxxxx na XXXX buňkách

** Tato xxxxxxxx xxxxxxxx jsou xxxxx xxxxxx xxxx xx, která xxxx xxxxx xxxxxxxxx xxxx 40-8-32 D xxxxxxxx xxxxxxxx pro xxxxx xxxx 1, 2 x 3, xxx xxxxxx jinou xxxxxxx xxxxxxxxxxxxxx xxxxxxx

1xx) xxxxxxxxxxx xxxxxxxx látka xxxxx xxxxxxxxxxxxx xxxxxxxx

Xxxxx xxxxx (0,5 ml) xxxxxxxx:

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

xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 3 ^1,2 2,2 µg

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

1 Konjugován s xxxxxx proteinem XXX₁₉₇ (xxxxxxxxx 51 µg xx dávku)

2 Adsorbován xx fosforečnan xxxxxxx (0,125 xx xxxxxxx xx xxxxx)

XXXX

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

1chaa) xxxxxxxxxxx xxxxxxxx xxxxx 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 xxxxxxxxxx

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

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

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 6B^1,2 xxxxxxxxxxxxxxx 4,0 xxxxxxxxxx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 7X^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 19A^1,2 xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx

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

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

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

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

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

² Xxxxxxxxxx xx xxxxxxxx xxxxxxxxxxx xxxxxxx

X

1xxxx) xxxx xxxxxxxxxxx xxxxxxxx xxxxx xxxxxxxx:

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

XXXX

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

1xxxx) xxxxxxxxxxx xxxxxxxx xxxxx xxxxxxxx:

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 1¹ 2,2µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 3¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum xxxxxxxxx 4¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 5¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum xxxxxxxxx 6X¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 6X¹ 4,4 µx

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 7X¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 9X¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 14¹ 2,2 µx

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 18C¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 19X¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum xxxxxxxxx 19X¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 23X¹ 2,2 µx

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

X

1xxxx) xxxx xxxxxxxxxxx xxxxxxxx xxxxx xxxxxxxx:

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

1x) xxxxxxxx xxxxx xxxxx záškrtu, xxxxxxxx xxxxx (xxxxxxxxxx xxxxx), xxxxxx, xxxxxx xxxxxxxx xxxxx (xxxxxxxxxxxx xxxxx):

Xxxxx xxxxx (0,5 ml) xxxxxxxx:

Xxxxxxxxxxx xxxxxxxxxx¹ - xx xxxx xxx 2 mezinárodní 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 antigenu

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

xxxxx 3 (kmen Xxxxxxx)² 32 X xxxxxxxx xxxxxxxx

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

² xxxxxxxxx xx XXXX buňkách

NEBO

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

Jedna xxxxx (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx xxxxxxxxxx xxxxxxxxx 2 XX¹ (2 Xx)

Xxxxxx xxxxxxxxxx xxxxxxxxx 20 XX¹ (5 Xx)

Xxxxxxxxx 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 (Mahoney) 29 X jednotek antigenu³

typus 2 (XXX1) 7 X jednotek xxxxxxxx³

xxxxx 3 (Saukett) 26 X xxxxxxxx xxxxxxxx³

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

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

² Xxxxxxxxxxx xx Vero xxxxxxx

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

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

** Xxxxxxxxxxx xx Xxxx xxxxxxx.

1x) xxxxxxxx xxxxx proti xxxxxxxxxxx (XXX xxxxxxx)

1x) xxxxxxxx látka xxxxx xxxxxx hepatitidě X xxx xxxxx xxxxxxxx xx dialyzačního xxxxxxxx:

Xxxxx xxxxx (0,5 xx) xxxxxxx xxxxxxxx:

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

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

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

³ vyrobeno xx xxxxxxx xxxxxxxxxxxx xxxxx (Xxxxxxxxxxxxx xxxxxxxxxx) xxxxxxxxxxxxx XXX xxxxxxxxxxx.

2. Xxxxxxxxx xxxxxxx očkovacích xxxxx pro xxxxxxxx xxxxxxxx

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

Xxxxx dávka xxxxxxxx:

Xxxxxxxxx tegiminis xxxxxxxxxxx X - 20 xxxxxxxxxx

2x) očkovací xxxxx xxxxx vzteklině

2c) očkovací xxxxx xxxxx xxxxxx xxxxxxxxxx A xx xxxxxxx xxx dospělé:

Jedna xxxxx xxxxxxxx:

Xxxxxxxxx A xxxxx xxxxxxxxxxx

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

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

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

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

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

¹ xxxxxxxxx xx buňkách xxxxxxxx embryí

² xxxxxxxxx xx xxxxxxxx diploidních xxxxxxx (XXX-5)

³ 50% xxxxxxxx dávka tkáňové xxxxxxx

XXXX

2xx) xxxxxxxx xxxxx xxxxx spalničkám, příušnicím x zarděnkám

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

Virus xxxxxxxxxxx¹ xxxxx attenuatum (kmen Xxxxxx’ Xxxxxxxxx) ne xxxx xxx 1x10³ XXXX₅₀*

Xxxxx xxxxxxxxxxx¹ vivum xxxxxxxxxx (kmen Xxxxx 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 dávka xxxxxxx xxxxxxx

¹ xxxxxxxx xx 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 X ve xxxxxxx xxx xxxxxxx:

Xxxxx xxxxxxxxx A xxxxxxxxxxx

3x) xxxxxxxx xxxxx xxxxx xxxxxx hepatitidě X xx xxxxxxx xxx xxxx:

Xxxxx xxxxxxxxx A xxxxxxxxxxx

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

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

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

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

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

¹ xxxxxxxxx xx buňkách kuřecích xxxxxx

² xxxxxxxxx na xxxxxxxx diploidních buňkách (XXX-5)

³ 50% xxxxxxxx xxxxx xxxxxxx xxxxxxx

XXXX

3xx) xxxxxxxx xxxxx proti xxxxxxxxxx, xxxxxxxxxx a xxxxxxxxx

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

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

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

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

* 50% xxxxxxxx xxxxx xxxxxxx xxxxxxx

¹ xxxxxxxx xx xxxxxxx xxxxxxxx xxxxxx

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

Xxxxxxx:

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

Xxxxxxxxx

Xxxxxx xxxxxxx č. 375/2024 Xx. nabyl xxxxxxxxx xxxx 10.12.2024.

Xx xxx xxxxxxxx xxxxx xxxxx xx doplňován.

Znění xxxxxxxxxxxx právních xxxxx xxxxxx právních xxxxxxxx x xxxxxxxx xxxx xxxxxxxxxxxxx, xxxxx se xxxx netýká xxxxxxxxx xxxxx xxxxx uvedeného xxxxxxxx xxxxxxxx.