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 zdravotnictví

ze dne 5. xxxxxxxx 2024

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

Xxxxxxxxxxxx xxxxxxxxxxxxx xxxxx §80 xxxx. 1 xxxx. x) xxxxxx x. 258/2000 Sb., x xxxxxxx xxxxxxxxx xxxxxx x x xxxxx xxxxxxxxx souvisejících xxxxxx, xx xxxxx xxxxxxxxxx předpisů, xxxxxxx xx základě xxxxxxxxxx Xxxxxxx xxxxxxxxxx xxxxxx xxxxxxxxx xxxxxxx očkovacích xxxxx pro xxxxxxxxxx, xxxxxxxx x xxxxxxxxx xxxxxxxx xxx xxx 2025:

1. Xxxxxxxxx xxxxxxx xxxxxxxxxx xxxxx xxx xxxxxxxxxx očkování

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

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

Xxxxxxxxxxx xxxxxxxxxx¹ xx xxxx xxx 30 xxxxxxxxxxxxx xxxxxxxx (XX)

Xxxxxx xxxxxxxxxx1 xx xxxx xxx 40 xxxxxxxxxxxxx xxxxxxxx (XX)

Xxxxxxxx Xxxxxxxxxx xxxxxxxxx:

Xxxxxxxxx xxxxxxxxxx (XX)¹ 25 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxxxx xxxxxxxxxxxx (XXX)¹ 25 mikrogramů

Pertactinum (XXX)¹ 8 xxxxxxxxxx

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

Xxxxx xxxxxxxxxxxxxxx inactivatum (XXX)

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

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

typus 3 (xxxx Xxxxxxx)⁴ 32 X xxxxxxxx xxxxxxxx

Xxxxxxxxxxx xxxxxxxxxx typus x xxxxxxxxxxxxxxx

(Xxxxxxxxxxxxxxxxxxx xxxxxxxx) 10 xxxxxxxxxx

xxxx. cum xxxxxx. xxxxxxxx xxxx xxxxx protein xxxxxxxxx 25 xxxxxxxxxx

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

² vyrobeno xxxxxxxxxxxxx XXX technologií xx xxxxxxx xxxxxxxxxxxx xxxxx (Xxxxxxxxxxxxx xxxxxxxxxx)

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

⁴ xxxxxxxxx xx XXXX xxxxxxx

XXXX

1xx) xxxxxxxxxxx xxxxxxxx xxxxx xxxxx záškrtu, xxxxxxxx xxxxx (xxxxxxxxxx xxxxx), xxxxxx, xxxxxx xxxxxxxx xxxxx (inaktivovaná xxxxx), xxxxxx xxxxxxxxxx X, xxxxxxx xxxxxxxxx Xxxxxxxxxxx xxxxxxxxxx xxx x (XXxXXxxXXXXXX)

Xxxxx dávka¹ (0,5 xx) xxxxxxxx:

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

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

Xxxxxxxx Xxxxxxxxxx pertussis

Pertussis xxxxxxxxxx 25 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxxxx filamentosum 25 xxxxxxxxxx

Xxxxx Xxxxxxxxxxxxxxx (xxxxxxxxxxxx)⁵

xxxxx 1 (Xxxxxxx) 29 X xxxxxxxx xxxxxxxx⁶

xxxxx 2 (XXX-1) 7 X xxxxxxxx xxxxxxxx⁶

xxxxx 3 (Saukett) 26 X jednotek xxxxxxxx⁶

Xxxxxxxxx xxxxxxxxxxx X xxxxxxxxx⁷ 10 xxxxxxxxxx

Xxxxxxxxxx xxxxxxxxxx xxxx X xxxxxxxxxxxxxxx (Xxxxxxxxxxxxxxxxxxx xxxxxxxx) 12 xxxxxxxxxx coniugatum cum xxxxxx xxxxxxxx 22-36 xxxxxxxxxx

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

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

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

⁴ Xxxx xxxxxxxxxxxx xxxxxxxx xxxxxxxxx xxxxxxxxxx imunogenity

⁵ Kultivováno xx Vero xxxxxxx

⁶ Xxxx xxxxxxxx xxxxxxxx xxxx xxxxx stejná xxxx xx, která xxxx dříve vyjádřená xxxx 40-8-32 X xxxxxxxx xxxxxxxx xxx xxxxx xxxx 1, 2 x 3, xxx xxxxxx xxxxx xxxxxxx imunochemickou xxxxxxx

⁷ xxxxxxxx xxxxxxxxxxxxx XXX xxxxxxxxxxx v kvasinkových xxxxxxx Hansenula xxxxxxxxxx

XXXX

1xx) Xxxxxxx proti xxxxxxx, xxxxxx, dávivému xxxxx (xxxxxxxxxx xxxxxxxxxx), xxxxxxxxxx X (xXXX), dětské xxxxxxxx obrně (xxxxxxxxxxxx) x konjugovaná vakcína xxxxx Xxxxxxxxxxx xxxx x (adsorbovaná)

Jedna dávka (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx xxxxxxxxxx1 xx xxxx xxx 20 XX⁶

Xxxxxx xxxxxxxxxx1 xx méně xxx 40 XX⁶

Xxxxxxxx Xxxxxxxxxxx xxxxxxxx¹

Xxxxxxxxx xxxxxxxxxx (XX) 20 xxxxxxxxxx

Xxxxxxxxxxxxxxx xxxxxxxxxxxx (XXX) 20 xxxxxxxxxx

Xxxxxxxxxxx (XXX) 3 xxxxxxxxxx

Xxxxxxxx xxxx 2 xx 3 (FIM) 5 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx X ^2,3 10 xxxxxxxxxx

Xxxxx poliomyelitidis (xxxxxxxxxxx)⁴

Xxxxx 1 (Xxxxxxx) 40 X xxxxxxxx xxxxxxxx⁵

Xxxxx 2 (XXX-1) 8 X jednotek xxxxxxxx⁵

Xxxxx 3 (Xxxxxxx) 32 X xxxxxxxx xxxxxxxx⁵

Xxxxxxxxxxxxxx Xxxxxxxxxx xxxxxxxxxx xxxxx x

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

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

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

³ xxxxxxxx xxxxxxxxxxxxx XXX technologií x xxxxxxxxxxxx xxxxxxx Xxxxxxxxxxxxx cerevisiae

⁴ xxxxxxxxx xx Xxxx buňkách

⁵ xxxx xxxxxxxxxxxx xxxxxxxx xxxxxxxx xxxxxxxxx xxxxxxx xxxxxxxxxxxxxx xxxxxxx

⁶ xxxx xxxxxxxxxxxx xxxxxxxx xxxxxxxxx xxxxxxxxxxxx imunogenity

1b) xxxxxxxx xxxxx xxxxx xxxxxxx, xxxxxxxx kašli (xxxxxxxxxx xxxxx), xxxxxx (DTaP)

Jedna xxxxx (0,5 xx) xxxxxxxx xxxx léčivé xxxxx:

Xxxxxxxxxxx xxxxxxxxxx* ≥ 30 XX

Xxxxxx xxxxxxxxxx* ≥ 40 IU

Pertussis xxxxxxxxxx* (XX) 25 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxxxxx* (XXX) 25 xxxxxxxxxx

Xxxxxxxxxxx* (69xX) 8 xxxxxxxxxx

* xxxxxxxxxxx xx hydroxid xxxxxxx xxxxxx: 0,5 xxxxxxxxx

XXXX

1xx) Xxxxxxxx xxxxx xxxxx záškrtu, tetanu x dávivému xxxxx (xxxxxxxxxx) xx xxxxxxxx xxxxxxx xxxxxxxx (Xxxx)

Xxxxx xxxxx (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx anatoxinum - Xxxxxxxxx 2 XX* (2 Xx)

Xxxxxx anatoxinum - Xxxxxxxxx 20 XX* (5 Xx)

Xxxxxxxxx xxxxxxxx

Xxxxxxxxx anatoxinum - 2,5 mikrogramů

Haemagglutinum filamentosum - 5 xxxxxxxxxx

Xxxxxxxxxxx - 3 xxxxxxxxxx

Xxxxxxxx, xxxx 2 xx 3 - 5 xxxxxxxxxx

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

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

XXXX

1xx) Očkovací xxxxx proti záškrtu, xxxxxx a xxxxxxxx xxxxx (xxxxxxxxxx komponenta) xx sníženým obsahem xxxxxxxx (Tdap)

Jedna xxxxx (0,5 xx) obsahuje:

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

Xxxxxx anatoxinum¹ xx xxxx než 20 xxxxxxxxxxxxx xxxxxxxx (XX) (5 Lf)

Bordetellae pertussis xxxxxxxx:

Xxxxxxxxx anatoxinum¹ 8 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxx xxxxxxxxxxxx¹ 8 mikrogramů

Pertactinum¹ 2,5 xxxxxxxxxx

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

1x) očkovací xxxxx proti xxxxxxx xxxxxxxxx Xxxxxxxxxxx xxxxxxxxxx xxx b:

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

Haemophilus xxxxxxxxxx xxxxx b xxxx xxxxxxxxxxx 10 mikrogramů

konjugovaný x tetanickým toxoidem xxxx xxxxxxxxxxx nosičem xxxxxxxxx 25 xxxxxxxxxx

1x) xxxxxxxx látka xxxxx xxxxxx:

Xxxxx dávka xxxxxxxx:

Xxxxxx xxxxxxxxxx - xxx. 40 xxxxxxxxxxxxx xxxxxxxx

1x) xxxxxxxx xxxxx xxxxx xxxxxx xxxxxxxxxx X x xxxxxx formuli:

Jedna xxxxx obsahuje:

Antigenum tegiminis xxxxxxxxxxx X - 10 xxxxxxxxxx

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

Xxxxx xxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxx hepatitidis X - 20 xxxxxxxxxx

1x) očkovací xxxxx xxxxx xxxxxxxxxx, xxxxxxxxxx x xxxxxxxxx:

xxxxx xxxxxxxxxxxxxxx xxxxxxx (0,5 xx) xxxxxxxx:

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

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

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

¹ xxxxxxxxx xx xxxxxxx xxxxxxxx embryí

² xxxxxxxxx xx lidských xxxxxxxxxxx xxxxxxx (XXX-5)

³ 50% infekční dávka xxxxxxx kultury

NEBO

1ga) xxxxxxxx xxxxx xxxxx spalničkám, xxxxxxxxxx x zarděnkám

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

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

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

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

* 50% infekční dávka xxxxxxx kultury

¹ vyrobeno xx xxxxxxx xxxxxxxx xxxxxx.

² xxxxxxxx xx xxxxxxxx xxxxxxxxxxx plicních XX-38 xxxxxxxxxxxxx

1x) očkovací xxxxx xxxxx xxxxxx xxxxxxxx obrně v xxxxxxxxxxxx formě:

Jedna xxxxx (0,5 ml) xxxxxxxx:

Xxxxx xxxxxxxxxxxxx xxxxxxxxxxx xxxxx 1 (Xxxxxxx) ... 29 xxxxxxxxxxx X xxxxxxxx**

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

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

* Xxxxxxxxxxx xx XXXX xxxxxxx

** Xxxx xxxxxxxx antigenu xxxx xxxxx xxxxxx xxxx xx, která byla xxxxx vyjádřená 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 dávka (0,5 xx) obsahuje:

Polysacharid xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx sérotypu 1 ^1,2 2,2 µg

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

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

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

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

xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Streptococcus xxxxxxxxxx sérotypu 6B ^1,2 4,4 µg

polysacharid xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 7X ^1,2 2,2 µx

xxxxxxxxxxxx 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 pneumoniae xxxxxxxx 10X ^1,2 2,2 µx

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

xxxxxxxxxxxx bakterie (pneumokoka) Xxxxxxxxxxxxx pneumoniae sérotypu 12X ^1,2 2,2 µx

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

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

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

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

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

1 Xxxxxxxxxx s xxxxxx proteinem CRM₁₉₇ (xxxxxxxxx 51 µg xx xxxxx)

2 Xxxxxxxxxx xx xxxxxxxxxxx xxxxxxx (0,125 xx hliníku xx xxxxx)

XXXX

1xxx) očkovací xxxxx xxxxx pneumokokovým xxxxxxxx používané v xxxxxxxxxx xxxxxxxx:

1xxxx) konjugovaná xxxxxxxx xxxxx xxxxxxxx:

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 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 xxxxxxxxxx

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

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

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

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

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

Xxxxxxxxxxxx xxxxxxxxxx serotypi 18C^1,2 xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx

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

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

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 22F^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 mikrogramů

¹ Xxxxxxxxxx x xxxxxxxxxxx xxxxxxx CRM₁₉₇, CRM₁₉₇ xx xxxxxxxxx mutace xxxxxxxxxxxx xxxxxx (pocházejícího x Corynebacterium xxxxxxxxxxx X7) rekombinantně xxxxxxxxxxxxx x Xxxxxxxxxxx xxxxxxxxxxx

² Xxxxxxxxxx xx xxxxxxxx xxxxxxxxxxx hlinitý

A

1chab) xxxx xxxxxxxxxxx xxxxxxxx látka xxxxxxxx:

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

XXXX

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

1xxxx) xxxxxxxxxxx xxxxxxxx xxxxx xxxxxxxx:

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 1¹ 2,2µx

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 3¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum xxxxxxxxx 4¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 5¹ 2,2 µx

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 6X¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum xxxxxxxxx 6X¹ 4,4 µx

Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum xxxxxxxxx 7F¹ 2,2 µx

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 9X¹ 2,2 µx

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 14¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum xxxxxxxxx 18C¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum xxxxxxxxx 19X¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum xxxxxxxxx 19F¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum xxxxxxxxx 23X¹ 2,2 µx

¹ Konjugován x xxxxxx xxxxxxxxx XXX₁₉₇ x xxxxxxxxxx xx xxxxxxxxxxx xxxxxxx (0,125 xx hliníku)

A

1chbb) xxxx xxxxxxxxxxx očkovací xxxxx xxxxxxxx:

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

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

Xxxxx xxxxx (0,5 ml) xxxxxxxx:

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

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

Xxxxxxxxxxx pertussis xxxxxxxx:

Xxxxxxxxx xxxxxxxxxx¹ - 8 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxx xxxxxxxxxxxx¹ - 8 xxxxxxxxxx

Xxxxxxxxx1 2,5 mikrogramů

Virus xxxxxxxxxxxxxxx xxxxxxxxxxx:

xxxxx 1 (kmen Xxxxxxx)² 40 D xxxxxxxx xxxxxxxx

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

typus 3 (xxxx Xxxxxxx)² 32 X xxxxxxxx xxxxxxxx

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

² xxxxxxxxx xx XXXX xxxxxxx

XXXX

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

Xxxxx xxxxx (0,5 xx) obsahuje:

Diphtheriae 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 (inactivatum)²

typus 1 (Mahoney) 29 X xxxxxxxx xxxxxxxx³

xxxxx 2 (XXX1) 7 X jednotek antigenu³

typus 3 (Xxxxxxx) 26 X xxxxxxxx antigenu³

Adsorbováno xx fosforečnan hlinitý 1,5 xx (0,33 xx Al³⁺)

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

² Xxxxxxxxxxx na Vero xxxxxxx

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

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

** Kultivováno xx Vero xxxxxxx.

1x) xxxxxxxx látka xxxxx xxxxxxxxxxx (XXX xxxxxxx)

1x) xxxxxxxx látka xxxxx xxxxxx xxxxxxxxxx X xxx osoby zařazené xx dialyzačního programu:

Jedna xxxxx (0,5 xx) xxxxxxx xxxxxxxx:

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

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

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

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

2. Xxxxxxxxx xxxxxxx očkovacích xxxxx pro zvláštní xxxxxxxx

2x) xxxxxxxx látka xxxxx xxxxxx xxxxxxxxxx X ve xxxxxxx xxx xxxxxxx:

Xxxxx dávka xxxxxxxx:

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx X - 20 xxxxxxxxxx

2x) xxxxxxxx xxxxx xxxxx xxxxxxxxx

2x) xxxxxxxx xxxxx proti virové xxxxxxxxxx X xx xxxxxxx pro dospělé:

Jedna xxxxx xxxxxxxx:

Xxxxxxxxx X xxxxx xxxxxxxxxxx

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

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

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

Xxxxxxxxxxx xxxxx attenuatum¹ (XXX 4385) xxx. 10^3,7 infekční xxxxx xxx xxxxxxxx kulturu₅₀³

Rubeolae xxxxx attenuatum² (Wistar XX 27/3) xxx. 10^3,0 xxxxxxxx dávka xxx xxxxxxxx xxxxxxx₅₀³

¹ xxxxxxxxx xx xxxxxxx xxxxxxxx xxxxxx

² pomnoženo xx lidských xxxxxxxxxxx xxxxxxx (XXX-5)

³ 50% xxxxxxxx xxxxx xxxxxxx xxxxxxx

XXXX

2xx) očkovací xxxxx xxxxx spalničkám, příušnicím x zarděnkám

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

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

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

Xxxxx xxxxxxxx² xxxxx xxxxxxxxxx (kmen Xxxxxx XX 27/3) xx méně xxx 1x10³ CCID₅₀*

* 50% xxxxxxxx xxxxx xxxxxxx xxxxxxx

¹ vyrobeno na xxxxxxx xxxxxxxx xxxxxx

² xxxxxxxx na xxxxxxxx xxxxxxxxxxx xxxxxxx XX-38 xxxxxxxxxxxxx.

3. Xxxxxxxxx složení xxxxxxxxxx xxxxx xxx xxxxxxxxx xxxxxxxx

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

Xxxxx xxxxxxxxx X xxxxxxxxxxx

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

Xxxxx xxxxxxxxx X xxxxxxxxxxx

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

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

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

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

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

¹ pomnoženo xx xxxxxxx kuřecích xxxxxx

² pomnoženo xx xxxxxxxx xxxxxxxxxxx xxxxxxx (XXX-5)

³ 50% xxxxxxxx xxxxx xxxxxxx xxxxxxx

XXXX

3xx) xxxxxxxx xxxxx xxxxx xxxxxxxxxx, xxxxxxxxxx x xxxxxxxxx

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

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

Xxxxx xxxxxxxxxxx¹ xxxxx xxxxxxxxxx (xxxx Xxxxx Xxxx™, xxxxxxx B) xx xxxx než 12,5x10³ XXXX₅₀*

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

* 50% infekční xxxxx xxxxxxx xxxxxxx

¹ xxxxxxxx xx buňkách xxxxxxxx xxxxxx

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

Xxxxxxx:

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

Xxxxxxxxx

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

Ke xxx xxxxxxxx xxxxx xxxxx xx doplňován.

Znění xxxxxxxxxxxx xxxxxxxx norem xxxxxx xxxxxxxx xxxxxxxx x xxxxxxxx xxxx xxxxxxxxxxxxx, xxxxx se xxxx xxxxxx derogační xxxxx xxxxx xxxxxxxxx xxxxxxxx xxxxxxxx.