Plné znění - 472/2021 Sb.

Sdělení o antigenním složení očkovacích látek pro pravidelná, zvláštní a mimořádná očkování pro rok 2022

472/2021 Sb.
 

Sdělení Ministerstva zdravotnictví

INFORMACE

472

XXXXXXX

Xxxxxxxxxxxx xxxxxxxxxxxxx

xx xxx 30. xxxxxxxxx 2021

x xxxxxxxxxx xxxxxxx xxxxxxxxxx xxxxx pro pravidelná, xxxxxxxx x xxxxxxxxx xxxxxxxx pro xxx 2022
&xxxx;

Xxxxxxxxxxxx zdravotnictví xxxxx §80 xxxx. 1 xxxx. x) xxxxxx x. 258/2000 Xx., x ochraně xxxxxxxxx xxxxxx a x xxxxx xxxxxxxxx xxxxxxxxxxxxx xxxxxx, ve xxxxx xxxxxxxxxx předpisů, xxxxxxx xx xxxxxxx xxxxxxxxxx Xxxxxxx xxxxxxxxxx xxxxxx xxxxxxxxx složení xxxxxxxxxx xxxxx xxx pravidelná, xxxxxxxx x xxxxxxxxx xxxxxxxx xxx xxx 2022:

1. Xxxxxxxxx složení xxxxxxxxxx xxxxx xxx xxxxxxxxxx xxxxxxxx

1x) xxxxxxxxxxx xxxxxxxx látka xxxxx xxxxxxx, xxxxxxxx xxxxx (xxxxxxxxxx xxxxx), tetanu, xxxxxx xxxxxxxx obrně (xxxxxxxxxxxx xxxxx), virové xxxxxxxxxx X, nákazám xxxxxxxxx Haemophilus xxxxxxxxxx xxx b (DTaPHibVHBIPV)

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

Diphtheriae xxxxxxxxxx¹ ne xxxx xxx 30 xxxxxxxxxxxxx xxxxxxxx (IU)

Tetani xxxxxxxxxx¹ xx xxxx než 40 mezinárodních xxxxxxxx (XX)

Xxxxxxxx Xxxxxxxxxx pertussis:

Pertussis xxxxxxxxxx (PT)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)

xxxxx 1 (kmen Xxxxxxx)⁴ 40 D xxxxxxxx xxxxxxxx

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

xxxxx 3 (xxxx Saukett)⁴ 32 X jednotek xxxxxxxx

Xxxxxxxxxxx xxxxxxxxxx xxxxx b xxxxxxxxxxxxxxx

(Xxxxxxxxxxxxxxxxxxx xxxxxxxx) 10 xxxxxxxxxx

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

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

² xxxxxxxx rekombinantní XXX xxxxxxxxxxx xx xxxxxxx kvasinkových buněk (Xxxxxxxxxxxxx xxxxxxxxxx)

³ xxxxxxxxxxx xx fosforečnan xxxxxxx (XxXX₄) 0,32 xxxxxxxxx Xx³⁺

⁴ pomnoženo xx XXXX xxxxxxx

XXXX

1xx) xxxxxxxxxxx xxxxxxxx látka xxxxx xxxxxxx, dávivému xxxxx (xxxxxxxxxx forma), xxxxxx, xxxxxx přenosné xxxxx (xxxxxxxxxxxx xxxxx), xxxxxx xxxxxxxxxx X, nákazám xxxxxxxxx Xxxxxxxxxxx xxxxxxxxxx xxx x (XXxXXxxXXXXXX)

Xxxxx xxxxx¹ (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx anatoxinum xx xxxx xxx 20 xxxxxxxxxxxxx xxxxxxxx (XX)²

Xxxxxx xxxxxxxxxx ne xxxx xxx 40 mezinárodních xxxxxxxx (IU)²

Antigeny Xxxxxxxxxx xxxxxxxxx

Xxxxxxxxx xxxxxxxxxx 25 xxxxxxxxxx

Xxxxxxxxxxxxxx xxxxxxxxxxxx 25 xxxxxxxxxx

Xxxxx Xxxxxxxxxxxxxxx (xxxxxxxxxxxx)³

xxxxx 1 (Mahoney) 40 X xxxxxxxx xxxxxxxx⁴

xxxxx 2 (MEF-1) 8 X xxxxxxxx antigenu⁴

typus 3 (Xxxxxxx) 32 X xxxxxxxx xxxxxxxx⁴

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx X⁵ 10 xxxxxxxxxx

Xxxxxxxxxxxxxxxxxxx xxxxxxxx xxxxxxxxxx xxxxxxxxxx B 12 xxxxxxxxxx

(Xxxxxxxxxxxxxxxxxxx xxxxxxxx)

xxxxxxxxx xxx xxxxxx anatoxinum 22-36 mikrogramů

¹ xxxxxxxxxxx xx hydratovaný hydroxid xxxxxxx (0,6 xx Xx³⁺)

² xxxx xxxxxx xxx xxxxxxxxxxxxx (x = 0,95)

³ pomnoženo xx XXXX xxxxxxx

⁴ xxxx ekvivalentní xxxxxxxx xxxxxxxx xxxxxxxxx xxxxxxx xxxxxxxxxxxxxx xxxxxxx

⁵ xxxxxxxx xxxxxxxxxxxxx DNA technologií x kvasinkových buňkách Xxxxxxxxx xxxxxxxxxx

XXXX

1xx) Vakcína xxxxx xxxxxxxx, xxxxxx, xxxxxxx (xxxxxxxxxx komponenta), xxxxxxxxxx X (xXXX), xxxxxxxxxxxxxx (xxxxxxxxxxxx) x xxxxxxxxxxx xxxxxxx proti Xxxxxxxxxxx xxxx x (xxxxxxxxxxx)

Xxxxx dávka (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx anatoxinum¹ xx xxxx než 20 XX

Xxxxxx xxxxxxxxxx¹ xx xxxx xxx 40 XX

Xxxxxxxx Bordetellae xxxxxxxx¹

Xxxxxxxxx xxxxxxxxxx (XX) 20 mikrogramů

Haemagglutinium xxxxxxxxxxxx (XXX) 20 xxxxxxxxxx

Xxxxxxxxxxx (XXX) 3 xxxxxxxxxx

Xxxxxxxx xxxx 2 xx 3 (FIM) 5 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx X^2,3 10 mikrogramů

Virus xxxxxxxxxxxxxxx (xxxxxxxxxxx)⁴

Xxxxx 1 (Xxxxxxx) 40 X xxxxxxxx antigenu⁵

Typus 2 (XXX-1) 8 X xxxxxxxx xxxxxxxx⁵

Xxxxx 3 (Xxxxxxx) 32 D xxxxxxxx antigenu⁵

Polysaccharidi Xxxxxxxxxx xxxxxxxxxx typus x

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

¹ xxxxxxxxxxx xx xxxxxxxxxxx hlinitý (0,17 mg Xx³⁺)

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

³ xxxxxxxx xxxxxxxxxxxxx DNA xxxxxxxxxxx x xxxxxxxxxxxx xxxxxxx Xxxxxxxxxxxxx cerevisiae

⁴ xxxxxxxxx xx Vero xxxxxxx

⁵ nebo xxxxxxxxxxxx xxxxxxxx xxxxxxxx xxxxxxxxx xxxxxxx xxxxxxxxxxxxxx metodou.

1b) xxxxxxxx xxxxx xxxxx xxxxxxx, dávivému xxxxx (xxxxxxxxxx xxxxx), tetanu (XXxX)

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

Xxxxxxxxxxx xxxxxxxxxx* ≥ 30 XX

Xxxxxx xxxxxxxxxx* ≥ 40 XX

Xxxxxxxxx xxxxxxxxxx* (XX) 25 mikrogramů

Pertussis haemaglutininum xxxxxxxxxxxx* (FHA) 25 xxxxxxxxxx

Xxxxxxxxxxx* (69kD) 8 xxxxxxxxxx

* adsorbováno na xxxxxxxx xxxxxxx celkem: 0,5 xxxxxxxxx

XXXX

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

Xxxxx dávka (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx xxxxxxxxxx - Xxxxxxxxx 2 XX* (2 Xx)

Xxxxxx xxxxxxxxxx - Xxxxxxxxx 20 XX* (5 Xx)

Xxxxxxxxx antigeny

Pertussis xxxxxxxxxx - 2,5 xxxxxxxxxx

Xxxxxxxxxxxxxx xxxxxxxxxxxx - 5 xxxxxxxxxx

Xxxxxxxxxxx - 3 xxxxxxxxxx

Xxxxxxxx, xxxx 2 xx 3 - 5 mikrogramů

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

* Xxxx xxxxxx xxxxxxx intervalu xxxxxxxxxxxxx (p = 0,95) xxxxxxxx měřené xxxxx xxxxx xxxxxxxxx x Evropském xxxxxxxx.

XXXX

1xx) Xxxxxxxx látka xxxxx xxxxxxx, xxxxxx x xxxxxxxx kašli (acelulární xxxxxxxxxx) xx xxxxxxxx xxxxxxx antigenů (Xxxx)

Xxxxx xxxxx (0,5 xx) xxxxxxxx:

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

Xxxxxx anatoxinum¹ xx xxxx xxx 20 xxxxxxxxxxxxx xxxxxxxx (XX) (5 Xx)

Xxxxxxxxxxx xxxxxxxxx xxxxxxxx:

Xxxxxxxxx anatoxinum¹ 8 mikrogramů

Pertussis haemagglutinum xxxxxxxxxxxx¹ 8 mikrogramů

Pertussis xxxxxxxxx externae xxxxxxxxx¹ 2,5 xxxxxxxxxx

¹ xxxxxxxxxxx xx xxxxxxxxxxx xxxxxxxx xxxxxxx (Al(OH)₃) 0,3 xxxxxxxxx Al³⁺ a xxxxxxxxxxx xxxxxxx (AlPO₄) 0,2 xxxxxxxxx Xx³⁺

1x) xxxxxxxx xxxxx proti xxxxxxx xxxxxxxxx Haemophilus xxxxxxxxxx typ x:

Xxxxx xxxxx lyofilizované xxxxxxx xxxxxxxx:

Xxxxxxxxxxxxxxx Xxx xxxxxxxxxxx (10 xxxxxxxxxx) cum Xxxxxxxxx xxxxxxxx (xxxxxxxxx 25 mikrogramů).

1d) xxxxxxxx xxxxx proti tetanu:

Jedna xxxxx xxxxxxxx:

Xxxxxx xxxxxxxxxx - xxx. 40 xxxxxxxxxxxxx jednotek

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

Xxxxx xxxxx xxxxxxxx:

Xxxxxxxxx tegiminis xxxxxxxxxxx X - 10 xxxxxxxxxx

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

Xxxxx xxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx X - 20 xxxxxxxxxx

1x) xxxxxxxx látka xxxxx xxxxxxxxxx, xxxxxxxxxx a xxxxxxxxx:

Xxxxx xxxxx xxxxxxxx:

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

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

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

¹ xxxxxxxxx xx buňkách xxxxxxxx xxxxxx

² xxxxxxxxx xx xxxxxxxx diploidních xxxxxxx (XXX-5)

³ 50% xxxxxxxx dávka xxxxxxx xxxxxxx

XXXX

1xx) očkovací xxxxx xxxxx spalničkám, příušnicím x xxxxxxxxx

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

Virus xxxxxxxxxxx¹ xxxxx xxxxxxxxxx (xxxx Xxxxxx’ Xxxxxxxxx) ne xxxx než 1x10³ XXXX₅₀*

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

Xxxxx rubeolae² xxxxx attenuatum (xxxx Xxxxxx XX 27/3) xx xxxx než 1x10³ CCID₅₀*

* 50 % xxxxxxxx dávka xxxxxxx xxxxxxx

¹ vyrobeno xx buňkách xxxxxxxx xxxxxx.

² xxxxxxxx na xxxxxxxx xxxxxxxxxxx xxxxxxxx XX-38 fibroblastech.

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

Xxxxx xxxxx xxxxxxxx:

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

Xxxxx xxxxxxxxxxxxx xxxxxxxxxxx xxxxx 2 (MEF-1) .........8 xxxxxxxxxxx X xxxxxxxx*

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

* xxxx xxxxxxxx xxxxxxxxxxxxxx antigenů xxxxxxxxx xxxxxx xxxxxx xxxxxxxxxxxxx xxxxxx.

1xx) xxxxxxxx xxxxx xxxxx pneumokokovým xxxxxxxx používané x xxxxxxxxxx xxxxxxxx:

1xxx) konjugovaná xxxxxxxx látka xxxxxxxx:

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 1¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum xxxxxxxxx 3¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum xxxxxxxxx 4¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum xxxxxxxxx 5¹ 2,2 µg

Streptococci xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 6X¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 6X¹ 4,4 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 7X¹ 2,2 µg

Streptococci xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 9X¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 14₁ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 18X¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx 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 nosným xxxxxxxxx XXX197 a xxxxxxxxxx xx fosforečnan xxxxxxx (0,125 mg xxxxxxx).

X

1xxx) xxxxxxxxxxxxxxx xxxxxxxx xxxxx obsahuje:

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

1x) očkovací xxxxx proti xxxxxxx, xxxxxxxx xxxxx (acelulární xxxxx), tetanu, xxxxxx xxxxxxxx xxxxx (inaktivovaná xxxxx):

Xxxxx xxxxx (0,5 xx) obsahuje:

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

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

Bordetellae xxxxxxxxx antigena:

Pertussis xxxxxxxxxx¹ - 8 mikrogramů

Pertussis xxxxxxxxxxxxxx xxxxxxxxxxxx¹ - 8 xxxxxxxxxx

Xxxxxxxxx¹ 2,5 xxxxxxxxxx

Xxxxx poliomyelitidis xxxxxxxxxxx:

xxxxx 1 (xxxx Xxxxxxx)² - 40 X xxxxxxxx xxxxxxxx

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

xxxxx 3 (xxxx Xxxxxxx)² - 32 X xxxxxxxx xxxxxxxx

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

² pomnoženo xx XXXX buňkách

NEBO

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

Xxxxx dávka (0,5 xx) xxxxxxxx:

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

Xxxxxx anatoxinum xxxxxxxxx 20 IU* (5 Lf)

Pertusové xxxxxxxx:

Xxxxxxxxx xxxxxxxxxx 2,5 mikrogramů

Pertussis xxxxxxxxxxxxxxxx filamentosum 5 xxxxxxxxxx

Xxxxxxxxxxx 3 mikrogramy

Fimbriae, xxxx 2 et 3 5 xxxxxxxxxx

Xxxxx xxxxxxxxxxxxxxx (xxxxxxxxxxx)**

xxxxx 1 40 D jednotek xxxxxxxx

xxxxx 2 8 X xxxxxxxx xxxxxxxx

xxxxx 3 32 X xxxxxxxx xxxxxxxx

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

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

** Kultivováno xx Vero xxxxxxx.

1x) xxxxxxxx xxxxx xxxxx xxxxxxxxxxx (XXX xxxxxxx)

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

Jedna xxxxx (0,5 ml) xxxxxxx xxxxxxxx:

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

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

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

³ xxxxxxxx xx xxxxxxx kvasinkových xxxxx (Xxxxxxxxxxxxx xxxxxxxxxx) xxxxxxxxxxxxx DNA xxxxxxxxxxx.

2. Xxxxxxxxx xxxxxxx xxxxxxxxxx xxxxx pro xxxxxxxx xxxxxxxx

2x) očkovací látka xxxxx xxxxxx hepatitidě X xx xxxxxxx xxx xxxxxxx:

Xxxxx xxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxx hepatitidis X - 20 xxxxxxxxxx

2x) xxxxxxxx xxxxx xxxxx vzteklině

2c) xxxxxxxx xxxxx xxxxx virové xxxxxxxxxx X ve xxxxxxx xxx xxxxxxx:

Xxxxx xxxxx xxxxxxxx:

Xxxxxxxxx A xxxxx xxxxxxxxxxx

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

Xxxxx xxxxx xxxxxxxx:

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

Xxxxxxxxxxx xxxxx xxxxxxxxxx¹ (RIT 4385) xxx. 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 xxxxxxxxx xx buňkách xxxxxxxx xxxxxx

² pomnoženo na xxxxxxxx diploidních xxxxxxx (XXX-5)

³ 50% xxxxxxxx xxxxx xxxxxxx xxxxxxx

XXXX

2xx) xxxxxxxx xxxxx xxxxx xxxxxxxxxx, xxxxxxxxxx a xxxxxxxxx

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

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

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

Xxxxx rubeolae² xxxxx xxxxxxxxxx (xxxx Wistar XX 27/3) ne xxxx než 1x10³ XXXX₅₀*

* 50 % xxxxxxxx xxxxx xxxxxxx xxxxxxx

¹ xxxxxxxx xx xxxxxxx xxxxxxxx xxxxxx.

² xxxxxxxx xx xxxxxxxx xxxxxxxxxxx plicních WI-38 xxxxxxxxxxxxx.

3. Antigenní xxxxxxx xxxxxxxxxx látek pro xxxxxxxxx xxxxxxxx

3x) xxxxxxxx xxxxx proti xxxxxx xxxxxxxxxx X xx xxxxxxx xxx dospělé:

Hepatitis X xxxxx xxxxxxxxxxx

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

Xxxxx hepatitis X xxxxxxxxxxx

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

Xxxxx xxxxx xxxxxxxx:

Xxxxxxxxxxx xxxxx attenuatum¹ (Xxxxxxx) xxx. 10^3,0 xxxxxxxx xxxxx xxx xxxxxxxx xxxxxxx₅₀³

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

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

¹ xxxxxxxxx na xxxxxxx xxxxxxxx xxxxxx

² xxxxxxxxx xx lidských xxxxxxxxxxx buňkách (MRC-5)

³ 50% xxxxxxxx dávka xxxxxxx xxxxxxx

XXXX

3xx) xxxxxxxx xxxxx xxxxx xxxxxxxxxx, xxxxxxxxxx x zarděnkám:

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

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

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

Xxxxx xxxxxxxx² vivum attenuatum (xxxx Xxxxxx XX 27/3) xx xxxx xxx 1x110³ CCID₅₀*

* 50 % xxxxxxxx xxxxx xxxxxxx xxxxxxx

¹ xxxxxxxx xx xxxxxxx xxxxxxxx xxxxxx.

² xxxxxxxx xx xxxxxxxx diploidních xxxxxxxx WI-38 fibroblastech.
 

Ministr:

Mgr. xx Xxx. Vojtěch, XXX, v. x.

Xxxxxxxxx

Xxxxxx xxxxxxx č. 472/2021 Sb. xxxxx xxxxxxxxx xxxx 14.12.2021.

Xx xxx xxxxxxxx právní xxxxxxx nebyl xxxxx xx xxxxxxxxx.

Xxxxx xxxxxxxxxxxx xxxxxxxx xxxxx xxxxxx xxxxxxxx xxxxxxxx x xxxxxxxx xxxx xxxxxxxxxxxxx, xxxxx xx jich xxxxxx derogační xxxxx xxxxx xxxxxxxxx právního xxxxxxxx.