Plné znění - 420/2023 Sb.

Sdělení Ministerstva zdravotnictví o antigenním složení očkovacích látek pro pravidelná, zvláštní a mimořádná očkování pro rok 2024

420/2023 Sb.
 

Sdělení Ministerstva zdravotnictví

INFORMACE

420

XXXXXXX

Xxxxxxxxxxxx xxxxxxxxxxxxx

xx xxx 19. xxxxxxxx 2023

x xxxxxxxxxx xxxxxxx xxxxxxxxxx xxxxx xxx pravidelná, xxxxxxxx x xxxxxxxxx xxxxxxxx pro xxx 2024
&xxxx;

Xxxxxxxxxxxx xxxxxxxxxxxxx podle §80 odst. 1 xxxx. x) xxxxxx x. 258/2000 Xx., x xxxxxxx xxxxxxxxx xxxxxx a o xxxxx některých xxxxxxxxxxxxx xxxxxx, xx znění xxxxxxxxxx předpisů, stanoví xx xxxxxxx doporučení Xxxxxxx imunizační xxxxxx xxxxxxxxx xxxxxxx xxxxxxxxxx xxxxx xxx pravidelná, xxxxxxxx x mimořádná xxxxxxxx pro xxx 2024:

1.&xxxx;Xxxxxxxxx xxxxxxx xxxxxxxxxx xxxxx xxx pravidelná xxxxxxxx

1x)&xxxx;xxxxxxxxxxx očkovací xxxxx xxxxx záškrtu, dávivému xxxxx (xxxxxxxxxx xxxxx), xxxxxx, xxxxxx přenosné xxxxx (inaktivovaná forma), xxxxxx xxxxxxxxxx X, xxxxxxx xxxxxxxxx Haemophilus xxxxxxxxxx xxx b (XXxXXxxXXXXXX)

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

Xxxxxxxxxxx anatoxinum¹ ne xxxx xxx 30 mezinárodních xxxxxxxx (XX)

Xxxxxx xxxxxxxxxx¹&xxxx;xx xxxx xxx 40 xxxxxxxxxxxxx jednotek (IU)

Antigeny Xxxxxxxxxx pertussis:

Pertussis anatoxinum (XX)¹&xxxx;25 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxxxx xxxxxxxxxxxx (XXX)¹&xxxx;25 mikrogramů

Pertactinum (XXX)¹&xxxx;8 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx X (XXx)^2,3&xxxx;10 xxxxxxxxxx

Xxxxx xxxxxxxxxxxxxxx xxxxxxxxxxx (XXX)

xx xxx 1 (xxxx Xxxxxxx)^4&xxxx;40 X xxxxxxxx xxxxxxxx

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

xxxxx 3 (xxxx Xxxxxxx)⁴&xxxx;32 D xxxxxxxx xxxxxxxx

Xxxxxxxxxxx xxxxxxxxxx xxxxx b xxxxxxxxxxxxxxx

(Xxxxxxxxxxxxxxxxxxx xxxxxxxx) 10 xxxxxxxxxx

xxxx. xxx xxxxxx. xxxxxxxx xxxx nosný protein xxxxxxxxx 25 xxxxxxxxxx

¹&xxxx;xxxxxxxxxxx xx xxxxxxxx hlinitý, xxxxxxxxxxx (Xx(XX)₃) 0,5 xxxxxxxxx Xx³⁺

²&xxxx;xxxxxxxx xxxxxxxxxxxxx XXX xxxxxxxxxxx na xxxxxxx xxxxxxxxxxxx xxxxx (Xxxxxxxxxxxxx cerevisiae)

³ adsorbováno na xxxxxxxxxxx hlinitý (XxXX₄) 0,32 xxxxxxxxx Xx³⁺

⁴&xxxx;xxxxxxxxx xx VERO buňkách

NEBO

1aa) kombinovaná xxxxxxxx xxxxx proti xxxxxxx, xxxxxxxx xxxxx (xxxxxxxxxx forma), xxxxxx, xxxxxx xxxxxxxx obrně (xxxxxxxxxxxx forma), xxxxxx xxxxxxxxxx X, nákazám xxxxxxxxx Xxxxxxxxxxx xxxxxxxxxx xxx x (XXxXXxxXXXXXX)

Xxxxx xxxxx¹&xxxx;(0,5 xx) xxxxxxxx:

Xxxxxxxxxxx xxxxxxxxxx ne méně xxx 20 mezinárodních xxxxxxxx (XX)²

Xxxxxx xxxxxxxxxx xx méně xxx 40 xxxxxxxxxxxxx xxxxxxxx (XX)²

Xxxxxxxx Xxxxxxxxxx xxxxxxxxx

Xxxxxxxxx xxxxxxxxxx 25 mikrogramů

Haemagglutinum xxxxxxxxxxxx 25 mikrogramů

Virus Xxxxxxxxxxxxxxx (inaktivovaný)³

typus 1 (Xxxxxxx) 40 X xxxxxxxx xxxxxxxx⁴

xx xxx 2 (XXX-1) 8 X xxxxxxxx xxxxxxxx⁴

xxxxx 3 (Xxxxxxx) 32 X xxxxxxxx xxxxxxxx⁴

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx X⁵&xxxx;10 xxxxxxxxxx

Xxxxxxxxxxxxxxxxxxx phosphas haemophili xxxxxxxxxx X 12 xxxxxxxxxx

(Xxxxxxxxxxxxxxxxxxx phosphas)

conjugata cum xxxxxx anatoxinum 22-36 xxxxxxxxxx

¹&xxxx;xxxxxxxxxxx xx xxxxxxxxxxx xxxxxxxx xxxxxxx (0,6 xx Al³⁺)

² jako xxxxxx xxx spolehlivosti (x = 0,95)

³ pomnoženo na XXXX xxxxxxx

⁴&xxxx;xxxx xxxxxxxxxxxx xxxxxxxx antigenu xxxxxxxxx xxxxxxx xxxxxxxxxxxxxx metodou

⁵ vyrobeno xxxxxxxxxxxxx XXX technologií x xxxxxxxxxxxx xxxxxxx Xxxxxxxxx polymorpha

NEBO

1ab) Vakcína proti xxxxxxx, xxxxxx, dávivému xxxxx (xxxxxxxxxx xxxxxxxxxx), xxxxxxxxxx B (xXXX), xxxxxx přenosné xxxxx (xxxxxxxxxxxx) x konjugovaná xxxxxxx xxxxx Xxxxxxxxxxx xxxx x (adsorbovaná)

Jedna xxxxx (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx xxxxxxxxxx¹&xxxx;xx méně xxx 20 IU

Tetani xxxxxxxxxx¹&xxxx;xx méně než 40 XX

Xxxxxxxx Bordetellae xxxxxxxx¹

Xxxxxxxxx xxxxxxxxxx (PT) 20 xxxxxxxxxx

Xxxxxxxxxxxxxxx filamentosum (XXX) 20 xxxxxxxxxx

Xxxxxxxxxxx (XXX) 3 xxxxxxxxxx

Xxxxxxxx xxxx 2 et 3 (XXX) 5 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx X&xxxx;^2,3&xxxx;10 xxxxxxxxxx

Xxxxx xxxxxxxxxxxxxxx (xxxxxxxxxxx)⁴

Xxxxx 1 (Xxxxxxx) 40 X jednotek xxxxxxxx⁵

Xxxxx 2 (MEF-1) 8 X xxxxxxxx xxxxxxxx⁵

Xxxxx 3 (Xxxxxxx) 32 D jednotek xxxxxxxx⁵

Xxxxxxxxxxxxxx Xxxxxxxxxx xxxxxxxxxx xxxxx x

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

¹&xxxx;xxxxxxxxxxx xx xxxxxxxxxxx hlinitý (0,17 xx Xx³⁺)

²&xxxx;xxxxxxxxxxx xx hydratovaný xxxxxxxx xxxxxxx sulfát (0,15 xx Xx³⁺)

³&xxxx;xxxxxxxx xxxxxxxxxxxxx XXX technologií x xxxxxxxxxxxx xxxxxxx Xxxxxxxxxxxxx xxxxxxxxxx

⁴&xxxx;xxxxxxxxx xx Vero xxxxxxx

⁵&xxxx;xxxx xxxxxxxxxxxx xxxxxxxx xxxxxxxx xxxxxxxxx xxxxxxx xxxxxxxxxxxxxx xxxxxxx.

1x)&xxxx;xxxxxxxx látka xxxxx xxxxxxx, xxxxxxxx xxxxx (xxxxxxxxxx forma), xxxxxx (XXxX)

Xxxxx dávka (0,5 xx) xxxxxxxx xxxx xxxxxx látky:

Diphtheriae xxxxxxxxxx* ≥ 30 XX

Xxxxxx anatoxinum* ≥ 40 XX

Xxxxxxxxx xxxxxxxxxx* (XX) 25 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxxx filamentosum* (XXX) 25 xxxxxxxxxx

Xxxxxxxxxxx* (69kD) 8 mikrogramů

* adsorbováno xx xxxxxxxx xxxxxxx xxxxxx: 0,5 xxxxxxxxx

XXXX

1xx)&xxxx;Xxxxxxxx látka xxxxx xxxxxxx, xxxxxx x xxxxxxxx kašli (xxxxxxxxxx) se xxxxxxxx xxxxxxx xxxxxxxx (Tdap)

Jedna xxxxx (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx xxxxxxxxxx - Xxxxxxxxx 2 XX* (2 Xx)

Xxxxxx xxxxxxxxxx - Xxxxxxxxx 20 XX* (5 Xx)

Xxxxxxxxx xxxxxxxx

Xxxxxxxxx xxxxxxxxxx - 2,5 mikrogramu

Haemagglutinum 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;Xxxx xxxxxx hranice xxxxxxxxx spolehlivosti (x = 0,95) xxxxxxxx xxxxxx xxxxx xxxxx xxxxxxxxx x Xxxxxxxxx xxxxxxxx.

XXXX

1xx)&xxxx;Xxxxxxxx xxxxx xxxxx xxxxxxx, tetanu x xxxxxxxx xxxxx (xxxxxxxxxx xxxxxxxxxx) se xxxxxxxx xxxxxxx antigenů (Xxxx)

Xxxxx xxxxx (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx xxxxxxxxxx¹&xxxx;xx méně xxx 2 xxxxxxxxxxx xxxxxxxx (XX) (2,5 Xx)

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

Xxxxxxxxxxx xxxxxxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxxx¹&xxxx;8 mikrogramu

Pertussis xxxxxxxxxxxxxx xxxxxxxxxxxx¹&xxxx;8 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxx xxxxxxxx proteinům¹ 2,5 xxxxxxxxxx

¹&xxxx;xxxxxxxxxxx xx xxxxxxxxxxx xxxxxxxx xxxxxxx (Xx(XX)₃) 0,3 xxxxxxxxx Xx^3+&xxxx;x xxxxxxxxxxx xxxxxxx (XXXX₄) 0,2 xxxxxxxxx Al³⁺

1c) očkovací xxxxx xxxxx xxxxxxx vyvolaným Xxxxxxxxxxx influenzae xxx x:

Xxxxx dávka lyofilizované xxxxxxx xxxxxxxx:

Xxxxxxxxxxxxxxx Xxx xxxxxxxxxxx (10 xxxxxxxxxx) xxx Xxxxxxxxx tetanico (xxxxxxxxx 25 xxxxxxxxxx).

1x)&xxxx;xxxxxxxx xxxxx proti xxxxxx:

Xxxxx xxxxx obsahuje:

Tetani xxxxxxxxxx - xxx. 40 xxxxxxxxxxxxx jednotek

1e) očkovací xxxxx xxxxx xxxxxx xxxxxxxxxx X v xxxxxx xxxxxxx:

Xxxxx xxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx X - 10 xxxxxxxxxx

1x)&xxxx;xxxxxxxx xxxxx xxxxx virové xxxxxxxxxx B x xxxxxxx formuli

Jedna xxxxx xxxxxxxx:

Xxxxxxxxx tegiminis hepatitidis X - 20 xxxxxxxxxx

1x)&xxxx;xxxxxxxx xxxxx xxxxx xxxxxxxxxx, příušnicím x xxxxxxxxx:

Xxxxx xxxxx obsahuje:

Morbillorum xxxxx xxxxxxxxxx¹&xxxx;(Xxxxxxx) xxx. 10^3,0&xxxx;xxxxxxxx xxxxx xxx xxxxxxxx kulturu₅₀³

Parotitidis xxxxx xxxxxxxxxx¹&xxxx;(XXX 4385) min. 10^3,7&xxxx;xxxxxxxx xxxxx pro xxxxxxxx kulturu₅₀³

Rubeolae xxxxx xxxxxxxxxx²&xxxx;(Xxxxxx RA 27/3) xxx. 10^3,0&xxxx;xxxxxxxx xxxxx xxx buněčnou kulturu₅₀³

¹ pomnoženo xx xxxxxxx xxxxxxxx xxxxxx

²&xxxx;xxxxxxxxx xx lidských xxxxxxxxxxx xxxxxxx (XXX-5)

³&xxxx;50% xxxxxxxx xxxxx xxxxxxx xxxxxxx

XXXX

1xx)&xxxx;xxxxxxxx látka xxxxx xxxxxxxxxx, příušnicím a xxxxxxxxx

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

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

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

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

*&xxxx;50% xxxxxxxx xxxxx xxxxxxx kultury

¹ vyrobeno xx xxxxxxx xxxxxxxx xxxxxx.

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

1x)&xxxx;xxxxxxxx xxxxx proti dětské xxxxxxxx xxxxx x xxxxxxxxxxxx formě:

Jedna xxxxx xxxxxxxx:

Xxxxx xxxxxxxxxxxxx inactivatum xxxxx 1 (Xxxxxxx) ..... 40 xxxxxxxxxxx X xxxxxxxx*

Xxxxx xxxxxxxxxxxxx xxxxxxxxxxx xxxxx 2 (XXX-1) .......... 8 xxxxxxxxxxx D xxxxxxxx*

Xxxxx xxxxxxxxxxxxx xxxxxxxxxxx typus 3 (Xxxxxxx) ........ 32 xxxxxxxxxxx X xxxxxxxx*

*&xxxx;xxxx xxxxxxxx xxxxxxxxxxxxxx xxxxxxxx xxxxxxxxx pomocí xxxxxx xxxxxxxxxxxxx xxxxxx.

1xx)&xxxx;xxxxxxxx xxxxx xxxxx pneumokokovým xxxxxxxx xxxxxxxxx v xxxxxxxxxx xxxxxxxx:

1xxx)&xxxx;xxxxxxxxxxx xxxxxxxx xxxxx obsahuje:

Streptococci pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 1^x&xxxx;2,2 μx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 3¹&xxxx;2,2 μx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 4¹&xxxx;2,2 μx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 5¹&xxxx;2,2 μx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 6X¹&xxxx;2,2 μx

Xxxxxxxxxxxx xxxxxxxxxx polysaecharidum xxxxxxxxx 6X¹&xxxx;4,4 μx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 7F¹ 2,2 μx

Xxxxxxxxxxxx xxxxxxxxxx polysaecharidum xxxxxxxxx 9V¹ 2,2 μg

Streptococci xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 14¹&xxxx;2,2 μg

Streptococci xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 18X¹&xxxx;2,2 μx

Xxxxxxxxxxxx xxxxxxxxxx polysaecharidum xxxxxxxxx 19A¹ 2,2 μx

Xxxxxxxxxxxx xxxxxxxxxx polysaecharidum sérotypus 19X¹&xxxx;2,2 μg

Streptococci pneumoniae xxxxxxxxxxxxxxx sérotypus 23X¹&xxxx;2,2 μx

¹ Konjugován x xxxxxx xxxxxxxxx XXX197 x adsorbován na xxxxxxxxxxx xxxxxxx (0,125 xx hliníku).

A

1chb) proti xxxxxxxxxxxxx xxxxxxxx

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

XXXX

1xxx)&xxxx;xxxxxxxxxxx xxxxxxxx xxxxx xxxxx pneumokokovým xxxxxxxx

Xxxxx xxxxx (0,5 xx) xxxxxxxx:

Xxxxxxxxxxxx xxxxxxxx (pneumokoka) Xxxxxxxxxxxxx pneumoniae xxxxxxxx 1&xxxx;^1,2&xxxx;2,2 μx

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

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

xxxxxxxxxxxx bakterie (pneumokoka) Xxxxxxxxxxxxx xxxxxxxxxx sérotypu 5&xxxx;^1,2&xxxx;2,2 μg

polysacharid xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx pneumoniae xxxxxxxx 6A ^1,2 2,2 μx

xxxxxxxxxxxx xxxxxxxx (pneumokoka) Streptococcus xxxxxxxxxx xxxxxxxx 6X&xxxx;^1,2&xxxx;4,4 μx

xxxxxxxxxxxx bakterie (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 7X&xxxx;^1,2&xxxx;2,2 μx

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

polysacharid xxxxxxxx (pneumokoka) Streptococcus xxxxxxxxxx xxxxxxxx 9X&xxxx;^1,2&xxxx;2,2 μx

xxxxxxxxxxxx xxxxxxxx (pneumokoka) Xxxxxxxxxxxxx xxxxxxxxxx sérotypu 10X&xxxx;^1,2&xxxx;2,2 μx

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

xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 12X&xxxx;^1,2&xxxx;2,2 μx

xxxxxxxxxxxx bakterie (pneumokoka) Xxxxxxxxxxxxx pneumoniae xxxxxxxx 14&xxxx;^1,2&xxxx;2,2 μx

xxxxxxxxxxxx bakterie (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 15X&xxxx;^1,2&xxxx;2,2 μx

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

xxxxxxxxxxxx bakterie (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 19X&xxxx;^1,2&xxxx;2,2 μx

xxxxxxxxxxxx bakterie (xxxxxxxxxx) Streptococcus pneumoniae xxxxxxxx 19X&xxxx;^1,2&xxxx;2,2 μx

xxxxxxxxxxxx xxxxxxxx (pneumokoka) Streptococcus xxxxxxxxxx xxxxxxxx 22X&xxxx;^1,2&xxxx;2,2 μx

xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx pneumoniae sérotypu 23X&xxxx;^1,2&xxxx;2,2 μx

xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 33X&xxxx;^1,2&xxxx;2,2 μg

¹ Xxxxxxxxxx x xxxxxx xxxxxxxxx CRM₁₉₇ (přibližně 51 μx xx xxxxx)

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

1x)&xxxx;xxxxxxxx xxxxx xxxxx xxxxxxx, xxxxxxxx kašli (acelulární xxxxx), xxxxxx, xxxxxx xxxxxxxx obrně (inaktivovaná xxxxx):

Xxxxx dávka (0,5 xx) xxxxxxxx:

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

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

Xxxxxxxxxxx xxxxxxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxxx^1-&xxxx;8 mikrogramů

Pertussis xxxxxxxxxxxxxx xxxxxxxxxxxx¹&xxxx;- 8 xxxxxxxxxx

Xxxxxxxxx¹&xxxx;2,5 xxxxxxxxxx

Xxxxx xxxxxxxxxxxxxxx xxxxxxxxxxx:

xx xxx 1 (xxxx Xxxxxxx)²&xxxx;- 40 D xxxxxxxx xxxxxxxx

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

xxxxx 3 (xxxx Xxxxxxx)²&xxxx;- 32 D xxxxxxxx xxxxxxxx

¹ adsorbováno xx xxxxxxxxxxx hydroxid xxxxxxx (Xx(XX)₃) 0,3 xxxxxxxxx Xx³⁺&xxxx;x fosforečnan hlinitý (XxXX₄) 0,2 xxxxxxxxx Xx³⁺

² xxxxxxxxx na XXXX xxxxxxx

XXXX

1xx)&xxxx;xxxxxxxx xxxxx xxxxx xxxxxxx, xxxxxxxx xxxxx (acelulární xxxxx), xxxxxx, xxxxxx xxxxxxxx xxxxx (inaktivovaná forma):

Jedna xxxxx (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx anatoxinum xxxxxxxxx 2 XX* (2,5 Xx)

Xxxxxx xxxxxxxxxx minimálně 20 IU* (5 Xx)

Xxxxxxxxx xxxxxxxx:

Xxxxxxxxx anatoxinum 2,5 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxxxx xxxxxxxxxxxx 5 xxxxxxxxxx

Xxxxxxxxxxx 3 mikrogramy

Fimbriae, xxxx 2 et 3 5 xxxxxxxxxx

Xxxxx xxxxxxxxxxxxxxx (xxxxxxxxxxx)**

xxxxx 1 40 X xxxxxxxx antigenu

ty xxx 2 8 X xxxxxxxx xxxxxxxx

xxxxx 3 32 D xxxxxxxx antigenu

Adsorbováno na xxxxxxxxxxx hlinitý 1,5 xx (0,33 xx xxxxxxx)

*&xxxx;Xxxx xxxxxx hranice xxxxxxxxx xxxxxxxxxxxxx (x = 0,95) aktivity xxxxxx xxxxx xxxxx xxxxxxxxx v Evropském xxxxxxxx.

**&xxxx;Xxxxxxxxxxx na Vero xxxxxxx.

1x)&xxxx;xxxxxxxx xxxxx xxxxx xxxxxxxxxxx (XXX xxxxxxx)

1x)&xxxx;xxxxxxxx xxxxx xxxxx virové xxxxxxxxxx X xxx xxxxx zařazené xx xxxxxxxxxxxx xxxxxxxx:

Xxxxx xxxxx (0,5 ml) xxxxxxx xxxxxxxx:

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

¹ xxxxxxxxxx xx XX04X xxxxxxxxxx: - 3-X-xxxxxx-4'-xxxxxxxxxxxx-xxxxx X (XXX)²&xxxx;50 mikrogramů

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

³ xxxxxxxx xx xxxxxxx kvasinkových xxxxx (Saccharomyces cerevisiae) xxxxxxxxxxxxx XXX xxxxxxxxxxx.

2.&xxxx;Xxxxxxxxx xxxxxxx xxxxxxxxxx xxxxx xxx zvláštní xxxxxxxx

2x)&xxxx;xxxxxxxx xxxxx xxxxx virové xxxxxxxxxx X ve xxxxxxx pro xxxxxxx:

Xxxxx xxxxx obsahuje:

Antigenum tegiminis xxxxxxxxxxx B - 20 xxxxxxxxxx

2x)&xxxx;xxxxxxxx xxxxx xxxxx xxxxxxxxx

2x)&xxxx;xxxxxxxx xxxxx xxxxx xxxxxx xxxxxxxxxx X xx xxxxxxx xxx xxxxxxx:

Xxxxx xxxxx xxxxxxxx:

Xxxxxxxxx X xxxxx xxxxxxxxxxx

2x)&xxxx;xxxxxxxx xxxxx xxxxx xxxxxxxxxx, xxxxxxxxxx x xxxxxxxxx:

Xxxxx dávka xxxxxxxx:

Xxxxxxxxxxx xxxxx attenuatum¹ (Schwarz) min. 10^3,0&xxxx;xxxxxxxx xxxxx pro xxxxxxxx xxxxxxx₅₀³

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

Xxxxxxxx virus xxxxxxxxxx^2&xxxx;(Xxxxxx XX 27/3) xxx. 10^3,0&xxxx;xxxxxxxx dávka xxx xxxxxxxx xxxxxxx₅₀³

¹&xxxx;xxxxxxxxx xx buňkách xxxxxxxx xxxxxx

²&xxxx;xxxxxxxxx na xxxxxxxx xxxxxxxxxxx xxxxxxx (XXX-5)

³&xxxx;50% xxxxxxxx dávka xxxxxxx xxxxxxx

XXXX

2xx)&xxxx;xxxxxxxx xxxxx xxxxx xxxxxxxxxx, příušnicím x xxxxxxxxx

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

Xxxxx morbillorum¹ vivum xxxxxxxxxx (xxxx Enders’ Xxxxxxxxx) xx xxxx xxx 1x10³&xxxx;XXXX₅₀*

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

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

*&xxxx;50% infekční xxxxx xxxxxxx xxxxxxx

¹&xxxx;xxxxxxxx na xxxxxxx kuřecích embryí.

² vyrobeno xx lidských xxxxxxxxxxx xxxxxxxx XX-38 xxxxxxxxxxxxx.

3.&xxxx;Xxxxxxxxx xxxxxxx xxxxxxxxxx xxxxx xxx mimořádná xxxxxxxx

3x)&xxxx;xxxxxxxx xxxxx xxxxx xxxxxx xxxxxxxxxx A xx xxxxxxx xxx xxxxxxx:

Xxxxx xxxxxxxxx X xxxxxxxxxxx

3x)&xxxx;xxxxxxxx xxxxx xxxxx xxxxxx xxxxxxxxxx X xx xxxxxxx xxx děti:

Virus xxxxxxxxx A xxxxxxxxxxx

3x)&xxxx;xxxxxxxx xxxxx xxxxx spalničkám, xxxxxxxxxx x zarděnkám:

Jedna xxxxx xxxxxxxx:

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

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

Xxxxxxxx xxxxx attenuatum² (Wistar XX 27/3) min. 10^3,0&xxxx;xxxxxxxx dávka pro xxxxxxxx kulturu₅₀³

¹ pomnoženo xx xxxxxxx xxxxxxxx xxxxxx

²&xxxx;xxxxxxxxx xx lidských xxxxxxxxxxx xxxxxxx (MRC-5)

³ 50% xxxxxxxx xxxxx xxxxxxx kultury

NEBO

3ca) očkovací xxxxx xxxxx spalničkám, xxxxxxxxxx x zarděnkám

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

Xxxxx xxxxxxxxxxx¹&xxxx;xxxxx xxxxxxxxxx (kmen Xxxxxx’ Xxxxxxxxx) ne xxxx xxx 1x10³ CCID₅₀*

Virus xxxxxxxxxxx¹&xxxx;xxxxx xxxxxxxxxx (kmen Xxxxx Lynn™, hladina X) xx xxxx xxx 12,5x10³&xxxx;XXXX₅₀*

Xxxxx xxxxxxxx²&xxxx;xxxxx xxxxxxxxxx (kmen Xxxxxx XX 27/3) xx xxxx xxx 1x1 10³&xxxx;XXXX₅₀*

*&xxxx;50% infekční xxxxx xxxxxxx xxxxxxx

¹&xxxx;xxxxxxxx na xxxxxxx xxxxxxxx xxxxxx.

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

Xxxxxxx:

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

Xxxxxxxxx

Xxxxxx předpis č. 420/2023 Xx. xxxxx xxxxxxxxx xxxx 29.12.2023.

Ke xxx uzávěrky xxxxxx xxxxxxx xxxxx měněn xx xxxxxxxxx.

Xxxxx xxxxxxxxxxxx xxxxxxxx xxxxx jiných xxxxxxxx předpisů x xxxxxxxx xxxx aktualizováno, xxxxx xx xxxx xxxxxx xxxxxxxxx xxxxx xxxxx xxxxxxxxx právního xxxxxxxx.