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 pro xxx 2025
&xxxx;

Xxxxxxxxxxxx zdravotnictví podle §80 xxxx. 1 xxxx. x) xxxxxx x. 258/2000 Xx., x xxxxxxx xxxxxxxxx xxxxxx a o xxxxx některých xxxxxxxxxxxxx xxxxxx, xx xxxxx xxxxxxxxxx xxxxxxxx, stanoví xx xxxxxxx doporučení Xxxxxxx xxxxxxxxxx xxxxxx xxxxxxxxx xxxxxxx očkovacích xxxxx xxx xxxxxxxxxx, xxxxxxxx a xxxxxxxxx xxxxxxxx xxx xxx 2025:

1. Antigenní xxxxxxx xxxxxxxxxx látek xxx xxxxxxxxxx xxxxxxxx

1x) xxxxxxxxxxx xxxxxxxx xxxxx xxxxx xxxxxxx, xxxxxxxx xxxxx (xxxxxxxxxx forma), tetanu, xxxxxx xxxxxxxx xxxxx (xxxxxxxxxxxx forma), xxxxxx xxxxxxxxxx X, xxxxxxx xxxxxxxxx Xxxxxxxxxxx xxxxxxxxxx xxx b (XXxXXxxXXXXXX)

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

Xxxxxxxxxxx xxxxxxxxxx¹ ne xxxx xxx 30 xxxxxxxxxxxxx xxxxxxxx (XX)

Xxxxxx xxxxxxxxxx1 xx xxxx než 40 xxxxxxxxxxxxx xxxxxxxx (XX)

Xxxxxxxx Bordetelly xxxxxxxxx:

Xxxxxxxxx xxxxxxxxxx (PT)¹ 25 xxxxxxxxxx

Xxxxxxxxx haemagglutininum xxxxxxxxxxxx (XXX)¹ 25 xxxxxxxxxx

Xxxxxxxxxxx (XXX)¹ 8 xxxxxxxxxx

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

Virus xxxxxxxxxxxxxxx xxxxxxxxxxx (XXX)

xx xxx 1 (kmen 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 xxxxx x xxxxxxxxxxxxxxx

(Xxxxxxxxxxxxxxxxxxx xxxxxxxx) 10 xxxxxxxxxx

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

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

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

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

⁴ xxxxxxxxx xx XXXX buňkách

NEBO

1aa) xxxxxxxxxxx očkovací xxxxx xxxxx xxxxxxx, dávivému xxxxx (xxxxxxxxxx xxxxx), xxxxxx, xxxxxx xxxxxxxx xxxxx (xxxxxxxxxxxx xxxxx), xxxxxx xxxxxxxxxx X, xxxxxxx xxxxxxxxx Haemophilus xxxxxxxxxx xxx x (XXxXXxxXXXXXX)

Xxxxx dávka¹ (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx xxxxxxxxxx xx xxxx xxx 20 mezinárodních jednotek (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 xxxxxxxxxxxx 25 xxxxxxxxxx

Xxxxx Poliomyelitidis (xxxxxxxxxxxx)⁵

xxxxx 1 (Xxxxxxx) 29 X xxxxxxxx xxxxxxxx⁶

xxxxx 2 (XXX-1) 7 X xxxxxxxx xxxxxxxx⁶

xxxxx 3 (Xxxxxxx) 26 X xxxxxxxx antigenu⁶

Tegiminis xxxxxxxxxxx X xxxxxxxxx⁷ 10 xxxxxxxxxx

Xxxxxxxxxx xxxxxxxxxx xxxx X polysaccharidum (Xxxxxxxxxxxxxxxxxxx xxxxxxxx) 12 xxxxxxxxxx coniugatum xxx xxxxxx xxxxxxxx 22-36 xxxxxxxxxx

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

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

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

⁴ Nebo xxxxxxxxxxxx xxxxxxxx stanovená xxxxxxxxxx xxxxxxxxxxx

⁵ Kultivováno xx Vero xxxxxxx

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

⁷ xxxxxxxx xxxxxxxxxxxxx XXX xxxxxxxxxxx x xxxxxxxxxxxx xxxxxxx Xxxxxxxxx xxxxxxxxxx

XXXX

1xx) Xxxxxxx xxxxx xxxxxxx, xxxxxx, xxxxxxxx kašli (xxxxxxxxxx xxxxxxxxxx), xxxxxxxxxx X (rDNA), xxxxxx xxxxxxxx obrně (inaktivovaná) x xxxxxxxxxxx xxxxxxx xxxxx Xxxxxxxxxxx xxxx x (adsorbovaná)

Jedna xxxxx (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx xxxxxxxxxx1 ne méně xxx 20 XX⁶

Xxxxxx xxxxxxxxxx1 xx xxxx xxx 40 XX⁶

Xxxxxxxx Xxxxxxxxxxx xxxxxxxx¹

Xxxxxxxxx xxxxxxxxxx (XX) 20 xxxxxxxxxx

Xxxxxxxxxxxxxxx xxxxxxxxxxxx (XXX) 20 xxxxxxxxxx

Xxxxxxxxxxx (PRN) 3 xxxxxxxxxx

Xxxxxxxx xxxx 2 xx 3 (XXX) 5 mikrogramů

Antigenum tegiminis xxxxxxxxxxx X ^2,3 10 xxxxxxxxxx

Xxxxx xxxxxxxxxxxxxxx (xxxxxxxxxxx)⁴

Xxxxx 1 (Xxxxxxx) 40 X xxxxxxxx xxxxxxxx⁵

Xxxxx 2 (XXX-1) 8 D jednotek xxxxxxxx⁵

Xxxxx 3 (Saukett) 32 X jednotek xxxxxxxx⁵

Xxxxxxxxxxxxxx Xxxxxxxxxx influenzae xxxxx x

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

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

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

³ vyrobeno xxxxxxxxxxxxx DNA xxxxxxxxxxx x xxxxxxxxxxxx xxxxxxx Xxxxxxxxxxxxx xxxxxxxxxx

⁴ xxxxxxxxx xx Xxxx xxxxxxx

⁵ xxxx xxxxxxxxxxxx množství xxxxxxxx stanovené xxxxxxx xxxxxxxxxxxxxx metodou

⁶ xxxx xxxxxxxxxxxx xxxxxxxx xxxxxxxxx xxxxxxxxxxxx xxxxxxxxxxx

1x) xxxxxxxx xxxxx proti xxxxxxx, xxxxxxxx xxxxx (acelulární xxxxx), xxxxxx (DTaP)

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

Xxxxxxxxxxx xxxxxxxxxx* ≥ 30 XX

Xxxxxx anatoxinum* ≥ 40 XX

Xxxxxxxxx xxxxxxxxxx* (XX) 25 xxxxxxxxxx

Xxxxxxxxx haemaglutininum xxxxxxxxxxxx* (XXX) 25 xxxxxxxxxx

Xxxxxxxxxxx* (69xX) 8 xxxxxxxxxx

* xxxxxxxxxxx xx hydroxid xxxxxxx celkem: 0,5 xxxxxxxxx

XXXX

1xx) Xxxxxxxx xxxxx xxxxx záškrtu, xxxxxx x xxxxxxxx xxxxx (xxxxxxxxxx) xx sníženým xxxxxxx xxxxxxxx (Xxxx)

Xxxxx xxxxx (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx xxxxxxxxxx - Xxxxxxxxx 2 XX* (2 Lf)

Tetani xxxxxxxxxx - Minimálně 20 XX* (5 Xx)

Xxxxxxxxx xxxxxxxx

Xxxxxxxxx xxxxxxxxxx - 2,5 mikrogramů

Haemagglutinum xxxxxxxxxxxx - 5 xxxxxxxxxx

Xxxxxxxxxxx - 3 xxxxxxxxxx

Xxxxxxxx, xxxx 2 xx 3 - 5 xxxxxxxxxx

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

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

XXXX

1xx) Xxxxxxxx xxxxx xxxxx xxxxxxx, xxxxxx x xxxxxxxx xxxxx (acelulární komponenta) xx sníženým xxxxxxx xxxxxxxx (Xxxx)

Xxxxx xxxxx (0,5 ml) xxxxxxxx:

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

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

Bordetellae pertussis xxxxxxxx:

Xxxxxxxxx anatoxinum¹ 8 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxx xxxxxxxxxxxx¹ 8 xxxxxxxxxx

Xxxxxxxxxxx¹ 2,5 xxxxxxxxxx

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

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

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

Haemophilus influenzae xxxxx x póly xxxxxxxxxxx 10 xxxxxxxxxx

xxxxxxxxxxx x xxxxxxxxxx xxxxxxxx xxxx xxxxxxxxxxx xxxxxxx xxxxxxxxx 25 mikrogramů

1d) xxxxxxxx xxxxx xxxxx xxxxxx:

Xxxxx xxxxx obsahuje:

Tetani xxxxxxxxxx - xxx. 40 xxxxxxxxxxxxx xxxxxxxx

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

Xxxxx xxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx X - 10 xxxxxxxxxx

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

Jedna dávka xxxxxxxx:

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx X - 20 xxxxxxxxxx

1x) xxxxxxxx látka xxxxx xxxxxxxxxx, xxxxxxxxxx x zarděnkám:

dávka xxxxxxxxxxxxxxx xxxxxxx (0,5 ml) xxxxxxxx:

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

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

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

¹ pomnoženo xx xxxxxxx xxxxxxxx embryí

² xxxxxxxxx xx lidských xxxxxxxxxxx xxxxxxx (XXX-5)

³ 50% xxxxxxxx xxxxx xxxxxxx kultury

NEBO

1ga) očkovací xxxxx xxxxx spalničkám, xxxxxxxxxx x xxxxxxxxx

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

Virus xxxxxxxxxxx¹ vivum xxxxxxxxxx (xxxx Xxxxxx’ Edmonston) xx méně xxx 1x10³ XXXX₅₀*

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

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

* 50% xxxxxxxx dávka xxxxxxx kultury

¹ xxxxxxxx xx xxxxxxx xxxxxxxx xxxxxx.

² xxxxxxxx na xxxxxxxx diploidních xxxxxxxx XX-38 xxxxxxxxxxxxx

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

Xxxxx xxxxx (0,5 xx) xxxxxxxx:

Xxxxx xxxxxxxxxxxxx inactivatum typus 1 (Xxxxxxx) ... 29 xxxxxxxxxxx D xxxxxxxx**

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

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

* Xxxxxxxxxxx na XXXX xxxxxxx

** Tato xxxxxxxx antigenu xxxx xxxxx xxxxxx jako xx, xxxxx byla xxxxx xxxxxxxxx xxxx 40-8-32 X xxxxxxxx xxxxxxxx pro xxxxx xxxx 1, 2 x 3, xxx xxxxxx jinou vhodnou xxxxxxxxxxxxxx xxxxxxx

1xx) xxxxxxxxxxx xxxxxxxx xxxxx proti xxxxxxxxxxxxx xxxxxxxx

Xxxxx xxxxx (0,5 xx) xxxxxxxx:

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

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

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

xxxxxxxxxxxx xxxxxxxx (pneumokoka) Streptococcus xxxxxxxxxx xxxxxxxx 7X ^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 xxxxxxxx 10X ^1,2 2,2 µx

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

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

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

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

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

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

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

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

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

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

1 Konjugován x xxxxxx xxxxxxxxx CRM₁₉₇ (xxxxxxxxx 51 µg xx xxxxx)

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

XXXX

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

1xxxx) 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 serotypi 4^1,2 xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx

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

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

Xxxxxxxxxxxx xxxxxxxxxx serotypi 6X^1,2 xxxxxxxxxxxxxxx 4,0 mikrogramů

Streptococci 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 xxxxxxxxxx

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

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

Streptococci xxxxxxxxxx xxxxxxxx 19F^1,2 xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 22X^1,2 xxxxxxxxxxxxxxx 2,0 mikrogramů

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

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

¹ Xxxxxxxxxx x proteinovým xxxxxxx XXX₁₉₇, XXX₁₉₇ xx xxxxxxxxx xxxxxx xxxxxxxxxxxx toxinu (pocházejícího x Corynebacterium xxxxxxxxxxx X7) xxxxxxxxxxxxx exprimováného x Pseudomonas xxxxxxxxxxx

² Xxxxxxxxxx xx xxxxxxxx xxxxxxxxxxx xxxxxxx

X

1xxxx) póly xxxxxxxxxxx očkovací xxxxx xxxxxxxx:

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

XXXX

1xxx) xxxxxxxx xxxxx xxxxx pneumokokovým infekcím xxxxxxxxx v xxxxxxxxxx xxxxxxxx:

1xxxx) xxxxxxxxxxx xxxxxxxx xxxxx obsahuje:

Streptococci xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 1¹ 2,2µx

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 3¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 4¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum xxxxxxxxx 5¹ 2,2 µx

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 6X¹ 2,2 µx

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 6X¹ 4,4 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 7X¹ 2,2 µx

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 9X¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 14¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 18C¹ 2,2 µx

Xxxxxxxxxxxx pneumoniae 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 xxxxxxxxx CRM₁₉₇ x adsorbován na xxxxxxxxxxx xxxxxxx (0,125 xx hliníku)

A

1chbb) xxxx xxxxxxxxxxx xxxxxxxx látka xxxxxxxx:

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

1x) xxxxxxxx xxxxx xxxxx xxxxxxx, dávivému xxxxx (acelulární xxxxx), xxxxxx, dětské xxxxxxxx xxxxx (inaktivovaná forma):

Jedna xxxxx (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx xxxxxxxxxx¹ - xx xxxx xxx 2 xxxxxxxxxxx xxxxxxxx (XX) (2,5 Lf)

Tetani xxxxxxxxxx¹-&xxxx; xx xxxx xxx 20 mezinárodních xxxxxxxx (XX) (5 Xx)

Xxxxxxxxxxx pertussis xxxxxxxx:

Xxxxxxxxx xxxxxxxxxx¹ - 8 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxx xxxxxxxxxxxx¹ - 8 mikrogramů

Pertaktin1 2,5 xxxxxxxxxx

Xxxxx xxxxxxxxxxxxxxx xxxxxxxxxxx:

xxxxx 1 (xxxx Xxxxxxx)² 40 X xxxxxxxx xxxxxxxx

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

xxxxx 3 (xxxx Xxxxxxx)² 32 X 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 xxxxxxx

XXXX

1xx) xxxxxxxx xxxxx xxxxx xxxxxxx, xxxxxxxx kašli (xxxxxxxxxx xxxxx), xxxxxx, xxxxxx přenosné obrně (xxxxxxxxxxxx xxxxx):

Xxxxx dávka (0,5 xx) obsahuje:

Diphtheriae xxxxxxxxxx minimálně 2 XX¹ (2 Xx)

Xxxxxx xxxxxxxxxx xxxxxxxxx 20 XX¹ (5 Xx)

Xxxxxxxxx xxxxxxxx:

Xxxxxxxxx anatoxinum 2,5 xxxxxxxxxx

Xxxxxxxxx haemagglutininum filamentosum 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 (Xxxxxxx) 26 X jednotek xxxxxxxx³

Xxxxxxxxxxx xx xxxxxxxxxxx hlinitý 1,5 mg (0,33 xx Al³⁺)

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

² Xxxxxxxxxxx na Vero xxxxxxx

³ Tato množství xxxxxxxx xxxx xxxxx xxxxxx xxxx ta, xxxxx byla dříve xxxxxxxxx jako 40-8-32 X xxxxxxxx antigenu xxx xxxxx xxxx 1, 2 a 3, xxx xxxxxx xxxxx xxxxxxx imunochemickou xxxxxxx

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

** Xxxxxxxxxxx xx Xxxx buňkách.

1j) xxxxxxxx xxxxx proti xxxxxxxxxxx (XXX xxxxxxx)

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

Jedna xxxxx (0,5 xx) xxxxxxx xxxxxxxx:

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

¹ xxxxxxxxxx xx AS04C xxxxxxxxxx: - 3-X-xxxxxx-4'-xxxxxxxxxxxx-xxxxx A (XXX)² 50 mikrogramů

² xxxxxxxxxxx na xxxxxxxxxxx xxxxxxx (celkem 0,5 xxxxxxxxx Xx³⁺)

³ xxxxxxxx xx kultuře xxxxxxxxxxxx xxxxx (Xxxxxxxxxxxxx xxxxxxxxxx) xxxxxxxxxxxxx XXX technologií.

2. Xxxxxxxxx složení xxxxxxxxxx xxxxx pro xxxxxxxx xxxxxxxx

2x) xxxxxxxx xxxxx xxxxx virové hepatitidě X ve formuli xxx xxxxxxx:

Xxxxx xxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxx hepatitidis X - 20 xxxxxxxxxx

2x) xxxxxxxx látka xxxxx xxxxxxxxx

2x) xxxxxxxx xxxxx xxxxx xxxxxx xxxxxxxxxx A ve xxxxxxx pro xxxxxxx:

Xxxxx xxxxx xxxxxxxx:

Xxxxxxxxx X xxxxx xxxxxxxxxxx

2x) xxxxxxxx xxxxx xxxxx spalničkám, xxxxxxxxxx x xxxxxxxxx:

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

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

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

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

¹ xxxxxxxxx na xxxxxxx xxxxxxxx embryí

² xxxxxxxxx xx lidských xxxxxxxxxxx xxxxxxx (XXX-5)

³ 50% xxxxxxxx dávka tkáňové xxxxxxx

XXXX

2xx) očkovací xxxxx xxxxx xxxxxxxxxx, příušnicím x zarděnkám

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

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

Xxxxx xxxxxxxxxxx¹ vivum xxxxxxxxxx (kmen Jeryl Xxxx™, hladina B) xx méně než 12,5x10³ XXXX₅₀*

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

* 50% xxxxxxxx xxxxx xxxxxxx xxxxxxx

¹ xxxxxxxx xx xxxxxxx xxxxxxxx xxxxxx

² xxxxxxxx xx xxxxxxxx xxxxxxxxxxx buňkách WI-38 xxxxxxxxxxxxx.

3. Xxxxxxxxx xxxxxxx xxxxxxxxxx látek pro xxxxxxxxx očkování

3a) očkovací xxxxx xxxxx virové xxxxxxxxxx X ve xxxxxxx xxx xxxxxxx:

Xxxxx xxxxxxxxx A inactivatum

3b) xxxxxxxx xxxxx xxxxx xxxxxx hepatitidě X xx formuli xxx xxxx:

Xxxxx xxxxxxxxx X xxxxxxxxxxx

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

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

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

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

Rubeolae xxxxx xxxxxxxxxx² (Wistar RA 27/3) xxx. 10^3,0 xxxxxxxx xxxxx xxx xxxxxxxx xxxxxxx₅₀³

¹ xxxxxxxxx xx xxxxxxx xxxxxxxx xxxxxx

² xxxxxxxxx xx xxxxxxxx xxxxxxxxxxx buňkách (XXX-5)

³ 50% xxxxxxxx xxxxx xxxxxxx xxxxxxx

XXXX

3xx) xxxxxxxx látka xxxxx xxxxxxxxxx, xxxxxxxxxx x xxxxxxxxx

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

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

Virus xxxxxxxxxxx¹ xxxxx xxxxxxxxxx (xxxx Jeryl Lynn™, xxxxxxx B) ne xxxx než 12,5x10³ XXXX₅₀*

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

* 50% xxxxxxxx xxxxx buněčné xxxxxxx

¹ xxxxxxxx xx buňkách xxxxxxxx embryí

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

Xxxxxxx:

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

Informace

Právní xxxxxxx č. 375/2024 Xx. nabyl xxxxxxxxx dnem 10.12.2024.

Xx xxx uzávěrky xxxxx xxxxx či doplňován.

Znění xxxxxxxxxxxx xxxxxxxx norem xxxxxx právních xxxxxxxx x xxxxxxxx xxxx xxxxxxxxxxxxx, pokud xx xxxx xxxxxx xxxxxxxxx xxxxx shora xxxxxxxxx xxxxxxxx xxxxxxxx.