Plné znění - 275/2019 Sb.

Sdělení o antigenním složení očkovacích látek pro pravidelná, zvláštní a mimořádná očkování pro rok 2020

275/2019 Sb.

Sdělení Ministerstva zdravotnictví

INFORMACE

275

SDĚLENÍ

Ministerstva xxxxxxxxxxxxx

xx dne 8. xxxxx 2019

x xxxxxxxxxx xxxxxxx xxxxxxxxxx xxxxx xxx pravidelná, xxxxxxxx a xxxxxxxxx xxxxxxxx pro rok 2020

 

Xxxxxxxxxxxx zdravotnictví xxxxx §80 odst. 1 xxxx. e) zákona x. 258/2000 Xx., x xxxxxxx veřejného xxxxxx a o xxxxx některých xxxxxxxxxxxxx xxxxxx, ve xxxxx xxxxxxxxxx xxxxxxxx, xxxxxxx xx xxxxxxx doporučení Xxxxxxx xxxxxxxxxx komise xxxxxxxxx složení xxxxxxxxxx xxxxx xxx xxxxxxxxxx, xxxxxxxx x xxxxxxxxx xxxxxxxx pro xxx 2020:

1. Antigenní xxxxxxx xxxxxxxxxx xxxxx xxx xxxxxxxxxx xxxxxxxx

1x) kombinovaná xxxxxxxx xxxxx xxxxx xxxxxxx, xxxxxxxx xxxxx (xxxxxxxxxx xxxxx), xxxxxx, xxxxxx xxxxxxxx obrně (xxxxxxxxxxxx xxxxx), virové xxxxxxxxxx X, xxxxxxx xxxxxxxxx Xxxxxxxxxxx xxxxxxxxxx xxx x (XXxXXxxXXXXXX):

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

Xxxxxxxxxxx xxxxxxxxxx¹ ne xxxx xxx 30 xxxxxxxxxxxxx xxxxxxxx (XX)

Xxxxxx anatoxinum¹ xx xxxx než 40 xxxxxxxxxxxxx xxxxxxxx (XX)

Xxxxxxxx Xxxxxxxxxx pertussis:

Pertussis xxxxxxxxxx (XX)¹ 25 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxxxx xxxxxxxxxxxx (XXX)¹ 25 xxxxxxxxxx

Xxxxxxxxxxx (XXX)¹ 8 xxxxxxxxxx

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

Xxxxx xxxxxxxxxxxxxxx xxxxxxxxxxx (XXX)

xxxxx 1 (xxxx Mahoney)⁴ 40 X xxxxxxxx xxxxxxxx

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

xxxxx 3 (xxxx Xxxxxxx)⁴ 32 X xxxxxxxx xxxxxxxx

Xxxxxxxxxxx xxxxxxxxxx typus x xxxxxxxxxxxxxxx

(Xxxxxxxxxxxxxxxxxxx xxxxxxxx) 10 xxxxxxxxxx

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

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

² vyrobeno rekombinantní XXX technologií xx xxxxxxx xxxxxxxxxxxx buněk (Xxxxxxxxxxxxx xxxxxxxxxx)

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

⁴ xxxxxxxxx na XXXX xxxxxxx

XXXX

1xx) xxxxxxxxxxx xxxxxxxx xxxxx proti xxxxxxx, xxxxxxxx kašli (xxxxxxxxxx xxxxx), tetanu, xxxxxx xxxxxxxx obrně (xxxxxxxxxxxx forma), virové xxxxxxxxxx X, xxxxxxx xxxxxxxxx Xxxxxxxxxxx xxxxxxxxxx xxx x (DTaPHibVHBIPV)

Jedna xxxxx¹ (0,5 xx) xxxxxxxx:

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

Xxxxxx xxxxxxxxxx xx xxxx xxx 40 mezinárodních xxxxxxxx (XX)²

Xxxxxxxx Xxxxxxxxxx xxxxxxxxx

Xxxxxxxxx anatoxinum 25 xxxxxxxxxx

Xxxxxxxxxxxxxx xxxxxxxxxxxx 25 xxxxxxxxxx

Xxxxx Xxxxxxxxxxxxxxx (inaktivovaný)³

typus 1 (Xxxxxxx) 40 X xxxxxxxx xxxxxxxx⁴

xxxxx 2 (XXX-1) 8 X jednotek xxxxxxxx⁴

xxxxx 3 (Xxxxxxx) 32 X jednotek xxxxxxxx⁴

Xxxxxxxxx xxxxxxxxx hepatitidis X⁵ 10 mikrogramů

Polyribosylribitoli xxxxxxxx xxxxxxxxxx xxxxxxxxxx B 12 xxxxxxxxxx

(Xxxxxxxxxxxxxxxxxxx xxxxxxxx)

xxxxxxxxx xxx xxxxxx anatoxinum 22-36 xxxxxxxxxx

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

² jako spodní xxx xxxxxxxxxxxxx (x = 0,95)

³ xxxxxxxxx xx XXXX xxxxxxx

⁴ xxxx xxxxxxxxxxxx xxxxxxxx xxxxxxxx stanovené xxxxxxx xxxxxxxxxxxxxx xxxxxxx

⁵ vyrobeno xxxxxxxxxxxxx DNA technologií x xxxxxxxxxxxx buňkách Xxxxxxxxx polymorpha

NEBO

1ab) Xxxxxxx xxxxx difterii, xxxxxx, xxxxxxx (xxxxxxxxxx xxxxxxxxxx), xxxxxxxxxx X (xXXX), xxxxxxxxxxxxxx (xxxxxxxxxxxx) x xxxxxxxxxxx xxxxxxx xxxxx Xxxxxxxxxxx typu x (xxxxxxxxxxx)

Xxxxx xxxxx (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 xxxxxxxxxx

Xxxxxxxxxxxxxxx xxxxxxxxxxxx (XXX) 20 mikrogramů

Pertactinum (XXX) 3 xxxxxxxxxx

Xxxxxxxx xxxx 2 et 3 (FIM) 5 xxxxxxxxxx

Xxxxxxxxx tegiminis xxxxxxxxxxx X^2,3 10 mikrogramů

Virus xxxxxxxxxxxxxxx (inactivatum)⁴

Typus 1 (Xxxxxxx) 40 X xxxxxxxx xxxxxxxx⁵

Xxxxx 2 (XXX-1) 8 D xxxxxxxx xxxxxxxx⁵

Xxxxx 3 (Xxxxxxx) 32 D xxxxxxxx antigenu⁵

Polysaccharidi Xxxxxxxxxx xxxxxxxxxx xxxxx x

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

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

² xxxxxxxxxxx na xxxxxxxxxxx xxxxxxxx xxxxxxx sulfát (0,15 xx Al³⁺)

³ xxxxxxxx xxxxxxxxxxxxx XXX xxxxxxxxxxx x xxxxxxxxxxxx xxxxxxx Xxxxxxxxxxxxx xxxxxxxxxx

⁴ xxxxxxxxx na Vero xxxxxxx

⁵ nebo ekvivalentní xxxxxxxx xxxxxxxx stanovené xxxxxxx xxxxxxxxxxxxxx metodou

1b) xxxxxxxx xxxxx proti xxxxxxx, xxxxxxxx xxxxx (xxxxxxxxxx forma), xxxxxx (XXxX):

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

Xxxxxxxxxxx anatoxinum* ≥ 30 IU

Tetani xxxxxxxxxx* ≥ 40 XX

Xxxxxxxxx xxxxxxxxxx* (XX) 25 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxxxxx* (XXX) 25 xxxxxxxxxx

Xxxxxxxxxxx* (69kD) 8 xxxxxxxxxx

* xxxxxxxxxxx xx xxxxxxxx hlinitý xxxxxx: 0,5 xxxxxxxxx

XXXX

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

Xxxxx xxxxx (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx anatoxinum - Xxxxxxxxx 2 XX* (2 Xx)

Xxxxxx xxxxxxxxxx - Minimálně 20 XX* (5 Lf)

Pertusové xxxxxxxx

Xxxxxxxxx anatoxinum - 2,5 xxxxxxxxxx

Xxxxxxxxxxxxxx xxxxxxxxxxxx - 5 mikrogramů

Pertactinum - 3 mikrogramy

Fimbriae, xxxx 2 xx 3 - 5 xxxxxxxxxx

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

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

NEBO

1bb) Xxxxxxxx xxxxx xxxxx záškrtu, xxxxxx x dávivému xxxxx (xxxxxxxxxx komponenta) xx sníženým obsahem xxxxxxxx

Xxxxx dávka (0,5 xx) obsahuje:

Diphtheriae xxxxxxxxxx¹ xx méně xxx 2 xxxxxxxxxxx jednotky (XX) (2,5 Xx)

Xxxxxx xxxxxxxxxx¹ xx méně xxx 20 xxxxxxxxxxxxx xxxxxxxx (IU) (5 Xx)

Xxxxxxxxxxx Xxxxxxxxx antigena:

Pertussis xxxxxxxxxx¹ 8 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxx xxxxxxxxxxxx¹ 8 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxx externae xxxxxxxxx¹ 2,5 mikrogramů

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

1x) očkovací látka xxxxx xxxxxxx vyvolaným Xxxxxxxxxxx influenzae typ x:

Xxxxx xxxxx xxxxxxxxxxxxx xxxxxxx xxxxxxxx:

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

1x) xxxxxxxx látka proti xxxxxx:

Xxxxx xxxxx obsahuje:

Tetani xxxxxxxxxx - min. 40 xxxxxxxxxxxxx xxxxxxxx

1x) xxxxxxxx látka proti xxxxxx xxxxxxxxxx X x xxxxxx formuli:

Jedna xxxxx obsahuje:

Antigenum xxxxxxxxx xxxxxxxxxxx X - 10 xxxxxxxxxx

1x) xxxxxxxx xxxxx xxxxx xxxxxx xxxxxxxxxx B x xxxxxxx formuli

Jedna xxxxx xxxxxxxx.

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx X - 20 xxxxxxxxxx

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

Xxxxx dávka xxxxxxxx:

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

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

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

¹ xxxxxxxxx xx xxxxxxx kuřecích xxxxxx

² xxxxxxxxx xx xxxxxxxx xxxxxxxxxxx xxxxxxx (MRC-5)

³ 50% xxxxxxxx dávka xxxxxxx xxxxxxx

XXXX

1xx) xxxxxxxx xxxxx xxxxx spalničkám, xxxxxxxxxx a xxxxxxxxx

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

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

Xxxxx xxxxxxxxxxx¹ xxxxx xxxxxxxxxx (xxxx Xxxxx Xxxx^XX, hladina X) xx xxxx xxx 12,5x103 CCID₅₀*

Virus xxxxxxxx² vivum xxxxxxxxxx (xxxx Xxxxxx XX 27/3) ne xxxx xxx 1x103 XXXX₅₀*

* 50 % infekční xxxxx xxxxxxx xxxxxxx

¹ xxxxxxxx xx buňkách xxxxxxxx xxxxxx

² xxxxxxxx xx lidských xxxxxxxxxxx xxxxxxxx WI-38 xxxxxxxxxxxxx

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

Xxxxx xxxxx xxxxxxxx:

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

Xxxxx xxxxxxxxxxxxx xxxxxxxxxxx typus 2 (MEF-1) … 8 antigenních X xxxxxxxx*

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

* xxxx xxxxxxxx xxxxxxxxxxxxxx antigenů xxxxxxxxx pomocí xxxxxx xxxxxxxxxxxxx xxxxxx

1xx) xxxxxxxx xxxxx xxxxxxxxxxx xxxxx xxxxxxxxxxxxx infekcím:

Jedna xxxxx xxxxxxxx:

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 1¹ 2,2 µx

Xxxxxxxxxxxx pneumoniae polysaccharidum xxxxxxxxx 3¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 4¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 5¹ 2,2 µx

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 6X¹ 2,2 µx

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 6X¹ 4,4 µx

Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum xxxxxxxxx 7X¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 9X¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 14¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 18C¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 19X¹ 2,2 µx

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 19X¹ 2,2 µx

Xxxxxxxxxxxx pneumoniae polysaccharidum xxxxxxxxx 23X¹ 2,2 µx

¹ Xxxxxxxxxx x xxxxxx xxxxxxxxx CRM197 x xxxxxxxxxx xx xxxxxxxxxxx xxxxxxx (0,125 xx hliníku)

1i) xxxxxxxx xxxxx xxxxx xxxxxxx, xxxxxxxx xxxxx (xxxxxxxxxx xxxxx), xxxxxx, dětské xxxxxxxx xxxxx (xxxxxxxxxxxx xxxxx):

Xxxxx xxxxx (0,5 xx) xxxxxxxx:

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

Xxxxxx xxxxxxxxxx¹ - xx méně xxx 20 mezinárodních xxxxxxxx (XX) (5 Xx)

Xxxxxxxxxxx Xxxxxxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxxx¹ - 8 mikrogramů

Pertussis xxxxxxxxxxxxxx filamentosum¹ - 8 mikrogramů

Pertaktin¹ 2,5 xxxxxxxxxx

Xxxxx poliomyelitidis xxxxxxxxxxx:

xxxxx 1 (kmen Mahoney)² - 40 X xxxxxxxx xxxxxxxx

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

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

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

² xxxxxxxxx xx XXXX xxxxxxx

1x) xxxxxxxx xxxxx xxxxx xxxxxxxxxxx (XXX xxxxxxx)

1x) očkovací xxxxx proti xxxxxx xxxxxxxxxx X pro xxxxx zařazené xx xxxxxxxxxxxx programu:

Jedna xxxxx (0,5 xx) xxxxxxx xxxxxxxx:

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

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

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

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

2. Xxxxxxxxx xxxxxxx xxxxxxxxxx látek xxx xxxxxxxx xxxxxxxx

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

Xxxxx dávka xxxxxxxx:

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx X - 20 xxxxxxxxxx

2x) xxxxxxxx xxxxx xxxxx xxxxxxxxx

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

Xxxxx xxxxx xxxxxxxx:

Xxxxxxxxx X virus xxxxxxxxxxx

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

Xxxxx xxxxx xxxxxxxx:

Xxxxxxxxxxx xxxxx xxxxxxxxxx¹ (Xxxxxxx) xxx. 10^3,0 xxxxxxxx xxxxx xxx xxxxxxxx kulturu₅₀³

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

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

¹ xxxxxxxxx xx xxxxxxx kuřecích embryí

² xxxxxxxxx xx xxxxxxxx xxxxxxxxxxx xxxxxxx (MRC-5)

³ 50% xxxxxxxx dávka xxxxxxx xxxxxxx

XXXX

2xx) očkovací xxxxx xxxxx xxxxxxxxxx, xxxxxxxxxx x zarděnkám

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

Xxxxx xxxxxxxxxxx¹ xxxxx xxxxxxxxxx (xxxx Enders’ Edmonston) xx xxxx xxx 1x103 CCID₅₀*

Virus xxxxxxxxxxx¹ xxxxx xxxxxxxxxx (kmen Xxxxx Lynn^TM, xxxxxxx X) ne xxxx xxx 12,5x103 CCID₅₀*

Virus xxxxxxxx² xxxxx xxxxxxxxxx (xxxx Xxxxxx XX 27/3) ne méně xxx 1x103 XXXX₅₀*

* 50 % xxxxxxxx xxxxx xxxxxxx xxxxxxx

¹ xxxxxxxx xx xxxxxxx xxxxxxxx xxxxxx

² xxxxxxxx xx xxxxxxxx diploidních xxxxxxxx XX-38 xxxxxxxxxxxxx

3. Xxxxxxxxx xxxxxxx xxxxxxxxxx xxxxx pro xxxxxxxxx xxxxxxxx

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

Xxxxxxxxx X xxxxx inactivatum

3b) xxxxxxxx xxxxx proti xxxxxx xxxxxxxxxx X xx xxxxxxx xxx xxxx:

Xxxxx xxxxxxxxx X xxxxxxxxxxx

3x) xxxxxxxx látka proti xxxxxxxxxx, příušnicím x xxxxxxxxx:

Xxxxx xxxxx xxxxxxxx:

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

¹ xxxxxxxxx xx buňkách xxxxxxxx embryí

² xxxxxxxxx xx xxxxxxxx xxxxxxxxxxx xxxxxxx (XXX-5)

³ 50% xxxxxxxx dávka tkáňové xxxxxxx

XXXX

3xx) xxxxxxxx xxxxx xxxxx xxxxxxxxxx, xxxxxxxxxx x xxxxxxxxx

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

Xxxxx xxxxxxxxxxx¹ xxxxx xxxxxxxxxx (xxxx Xxxxxx’ Edmonston) xx xxxx než 1x103 XXXX₅₀*

Xxxxx xxxxxxxxxxx¹ xxxxx xxxxxxxxxx (xxxx Xxxxx Xxxx^XX, hladina B) xx méně xxx 12,5x103 XXXX₅₀*

Xxxxx rubeolae² xxxxx attenuatum (kmen Xxxxxx XX 27/3) xx méně než 1x103 XXXX₅₀*

* 50 % xxxxxxxx xxxxx xxxxxxx kultury

¹ vyrobeno xx xxxxxxx xxxxxxxx xxxxxx

² xxxxxxxx na xxxxxxxx diploidních xxxxxxxx XX-38 fibroblastech.

 

Ministr:

Mgr. et Xxx. Xxxxxxx, MHA, x. x.

Xxxxxxxxx

Xxxxxx xxxxxxx č. 275/2019 Sb. nabyl xxxxxxxxx xxxx 21.11.2019.

Xx xxx uzávěrky xxxxxx xxxxxxx xxxxx xxxxx xx xxxxxxxxx.

Xxxxx jednotlivých xxxxxxxx xxxxx xxxxxx xxxxxxxx xxxxxxxx v xxxxxxxx není aktualizováno, xxxxx se xxxx xxxxxx derogační xxxxx xxxxx uvedeného xxxxxxxx xxxxxxxx.