Plné znění - 509/2020 Sb.

Sdělení o antigenním složení očkovacích látek pro pravidelná, zvláštní a mimořádná očkování pro rok 2021

509/2020 Sb.

Sdělení Ministerstva zdravotnictví

INFORMACE

509

XXXXXXX

Xxxxxxxxxxxx xxxxxxxxxxxxx

xx xxx 18. xxxxxxxxx 2020

o xxxxxxxxxx složení xxxxxxxxxx xxxxx xxx xxxxxxxxxx, xxxxxxxx x mimořádná xxxxxxxx pro rok 2021

 

Xxxxxxxxxxxx zdravotnictví xxxxx §80 xxxx. 1 xxxx. x) xxxxxx x. 258/2000 Sb., x ochraně xxxxxxxxx xxxxxx a x xxxxx xxxxxxxxx xxxxxxxxxxxxx xxxxxx, xx xxxxx xxxxxxxxxx xxxxxxxx, stanoví xx xxxxxxx doporučení Xxxxxxx imunizační xxxxxx xxxxxxxxx xxxxxxx očkovacích xxxxx pro xxxxxxxxxx, xxxxxxxx x mimořádná xxxxxxxx xxx xxx 2021:

1. Antigenní xxxxxxx xxxxxxxxxx xxxxx xxx xxxxxxxxxx xxxxxxxx

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

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

Xxxxxxxxxxx xxxxxxxxxx¹ xx xxxx xxx 30 xxxxxxxxxxxxx xxxxxxxx (XX)

Xxxxxx anatoxinum¹ xx xxxx xxx 40 mezinárodních xxxxxxxx (XX)

Xxxxxxxx Xxxxxxxxxx xxxxxxxxx:

Xxxxxxxxx xxxxxxxxxx (XX)¹ 25 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxxxx filamentosum (XXX)¹ 25 mikrogramů

Pertactinum (XXX)¹ 8 mikrogramů

Antigenum xxxxxxxxx hepatitidis B (XXx)^2,3 10 mikrogramů

Virus 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 jednotek xxxxxxxx

Xxxxxxxxxxx xxxxxxxxxx typus x xxxxxxxxxxxxxxx

(Xxxxxxxxxxxxxxxxxxx xxxxxxxx) 10 xxxxxxxxxx

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

¹ adsorbováno xx xxxxxxxx xxxxxxx, hydratovaný (Xx(XX)₃) 0,5 miligramů Xx³⁺

² xxxxxxxx xxxxxxxxxxxxx XXX xxxxxxxxxxx na xxxxxxx xxxxxxxxxxxx buněk (Xxxxxxxxxxxxx xxxxxxxxxx)

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

⁴ pomnoženo xx XXXX buňkách

NEBO

1aa) xxxxxxxxxxx xxxxxxxx xxxxx xxxxx xxxxxxx, dávivému kašli (xxxxxxxxxx xxxxx), xxxxxx, xxxxxx xxxxxxxx obrně (xxxxxxxxxxxx xxxxx), xxxxxx xxxxxxxxxx X, xxxxxxx xxxxxxxxx Haemophilus influenzae xxx b (XXxXXxxXXXXXX)

Xxxxx xxxxx¹ (0,5 xx) xxxxxxxx:

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

Tetani xxxxxxxxxx ne xxxx xxx 40 xxxxxxxxxxxxx xxxxxxxx (IU)²

Antigeny Bordetelly xxxxxxxxx

Xxxxxxxxx xxxxxxxxxx 25 xxxxxxxxxx

Xxxxxxxxxxxxxx xxxxxxxxxxxx 25 xxxxxxxxxx

Xxxxx Xxxxxxxxxxxxxxx (xxxxxxxxxxxx)³

xxxxx 1 (Xxxxxxx) 40 X jednotek xxxxxxxx⁴

xxxxx 2 (XXX-1) 8 X jednotek xxxxxxxx⁴

xxxxx 3 (Xxxxxxx) 32 X jednotek xxxxxxxx⁴

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx X⁵ 10 xxxxxxxxxx

Xxxxxxxxxxxxxxxxxxx phosphas xxxxxxxxxx xxxxxxxxxx X 12 xxxxxxxxxx

(Xxxxxxxxxxxxxxxxxxx xxxxxxxx)

xxxxxxxxx xxx xxxxxx xxxxxxxxxx 22-36 xxxxxxxxxx

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

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

³ pomnoženo xx XXXX xxxxxxx

⁴ xxxx xxxxxxxxxxxx xxxxxxxx xxxxxxxx xxxxxxxxx xxxxxxx xxxxxxxxxxxxxx xxxxxxx

⁵ xxxxxxxx xxxxxxxxxxxxx XXX xxxxxxxxxxx x kvasinkových xxxxxxx Xxxxxxxxx polymorpha

NEBO

1ab) Xxxxxxx xxxxx xxxxxxxx, xxxxxx, xxxxxxx (xxxxxxxxx komponenta), xxxxxxxxxx X (xXXX), xxxxxxxxxxxxxx (xxxxxxxxxxxx) x xxxxxxxxxxx vakcína xxxxx Xxxxxxxxxxx xxxx x (xxxxxxxxxxx)

Xxxxx xxxxx (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx xxxxxxxxxx¹ xx méně než 20 IU

Tetani anatoxinum¹ xx xxxx než 40 XX

Xxxxxxxx Xxxxxxxxxxx xxxxxxxx¹

Xxxxxxxxx xxxxxxxxxx (PT) 20 mikrogramů

Haemagglutinium xxxxxxxxxxxx (XXX) 20 mikrogramů

Pertactinum (XXX) 3 xxxxxxxxxx

Xxxxxxxx xxxx 2 et 3 (XXX) 5 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxx hepatitidis X^2,3 10 xxxxxxxxxx

Xxxxx xxxxxxxxxxxxxxx (inactivatum)⁴

Typus 1 (Xxxxxxx) 40 X xxxxxxxx xxxxxxxx⁵

Xxxxx 2 (XXX-1) 8 X xxxxxxxx xxxxxxxx⁵

Xxxxx 3 (Xxxxxxx) 32 D xxxxxxxx antigenu⁵

Polysaccharidi Xxxxxxxxxx xxxxxxxxxx xxxxx x

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

¹ xxxxxxxxxxx xx xxxxxxxxxxx hlinitý (0,17 xx Al³⁺)

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

³ xxxxxxxx rekombinantní XXX xxxxxxxxxxx x xxxxxxxxxxxx xxxxxxx Xxxxxxxxxxxxx xxxxxxxxxx

⁴ xxxxxxxxx xx Vero xxxxxxx

⁵ nebo ekvivalentní xxxxxxxx xxxxxxxx stanovené xxxxxxx imunochemickou xxxxxxx.

1x) xxxxxxxx xxxxx xxxxx xxxxxxx, dávivému kašli (xxxxxxxxxx xxxxx), xxxxxx (XXxX):

Xxxxx xxxxx (0,5 xx) obsahuje xxxx xxxxxx látky:

Diphtheriae anatoxinum* ≥ 30 XX

Xxxxxx xxxxxxxxxx* ≥ 40 XX

Xxxxxxxxx xxxxxxxxxx* (XX) 25 xxxxxxxxxx

Xxxxxxxxx haemaglutininum xxxxxxxxxxxx* (XXX) 25 xxxxxxxxxx

Xxxxxxxxxxx* (69xX) 8 xxxxxxxxxx

* adsorbováno xx xxxxxxxx hlinitý celkem: 0,5 miligramů

NEBO

1ba) Xxxxxxxx xxxxx xxxxx xxxxxxx, xxxxxx a xxxxxxxx xxxxx (xxxxxxxxxx) se xxxxxxxx xxxxxxx xxxxxxxx (Xxxx)

Xxxxx dávka (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx xxxxxxxxxx - Minimálně 2 XX* (2 Xx)

Xxxxxx xxxxxxxxxx - Xxxxxxxxx 20 XX* (5 Xx)

Xxxxxxxxx xxxxxxxx

Xxxxxxxxx xxxxxxxxxx - 2,5 xxxxxxxxxx

Xxxxxxxxxxxxxx xxxxxxxxxxxx - 5 xxxxxxxxxx

Xxxxxxxxxxx - 3 xxxxxxxxxx

Xxxxxxxx, typi 2 xx 3 - 5 mikrogramů

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

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

NEBO

1bb) Xxxxxxxx látka proti xxxxxxx, tetanu a xxxxxxxx xxxxx (acelulární xxxxxxxxxx) xx xxxxxxxx xxxxxxx xxxxxxxx (Tdap)

Jedna xxxxx (0,5 xx) xxxxxxxx:

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

Xxxxxx xxxxxxxxxx¹ xx xxxx xxx 20 mezinárodních jednotek (XX) (5 Xx)

Xxxxxxxxxxx xxxxxxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxxx¹ 8 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxx xxxxxxxxxxxx¹ 8 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxx xxxxxxx xxxxxxxxx¹ 2,5 xxxxxxxxxx

¹ adsorbováno xx xxxxxxxxxxx xxxxxxxx xxxxxxx (Xx(XX)₃) 0,3 xxxxxxxxx Xx³⁺ x xxxxxxxxxxx hlinitý (AlPO₄) 0,2 xxxxxxxxx Xx³⁺

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

Jedna xxxxx xxxxxxxxxxxxx vakcíny xxxxxxxx:

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

1x) xxxxxxxx xxxxx xxxxx xxxxxx:

Xxxxx xxxxx xxxxxxxx:

Xxxxxx xxxxxxxxxx - min. 40 xxxxxxxxxxxxx xxxxxxxx

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

Jedna dávka xxxxxxxx:

Xxxxxxxxx xxxxxxxxx hepatitidis X - 10 xxxxxxxxxx

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

Xxxxx xxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxx hepatitidis B - 20 mikrogramů

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

Xxxxx xxxxx xxxxxxxx:

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

Xxxxxxxxxxx xxxxx attenuatum¹ (XXX 4385) min. 10^3,7 infekční xxxxx xxx xxxxxxxx xxxxxxx₅₀³

Xxxxxxxx xxxxx xxxxxxxxxx² (Xxxxxx XX 27/3) min. 10^3,0 xxxxxxxx xxxxx xxx xxxxxxxx kulturu₅₀³

¹ xxxxxxxxx na buňkách xxxxxxxx xxxxxx

² xxxxxxxxx xx xxxxxxxx xxxxxxxxxxx xxxxxxx (XXX-5)

³ 50 % infekční xxxxx xxxxxxx xxxxxxx

XXXX

1xx) očkovací xxxxx xxxxx spalničkám, xxxxxxxxxx a xxxxxxxxx

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

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

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

Xxxxx xxxxxxxx² vivum attenuatum (xxxx Wistar XX 27/3) xx méně xxx 1x10³ CCID₅₀*

* 50 % infekční xxxxx xxxxxxx kultury

¹ xxxxxxxx xx xxxxxxx xxxxxxxx xxxxxx.

² vyrobeno xx xxxxxxxx xxxxxxxxxxx xxxxxxxx XX-38 xxxxxxxxxxxxx.

1x) xxxxxxxx xxxxx proti xxxxxx přenosné xxxxx x xxxxxxxxxxxx xxxxx:

Xxxxx xxxxx xxxxxxxx:

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

Xxxxx xxxxxxxxxxxxx inactivatum xxxxx 2 (MEF-1) ......… 8 antigenních X xxxxxxxx*

Xxxxx poliomyelitis inactivatum xxxxx 3 (Xxxxxxx) ...… 32 xxxxxxxxxxx X xxxxxxxx*

* nebo xxxxxxxx xxxxxxxxxxxxxx antigenů xxxxxxxxx pomocí xxxxxx xxxxxxxxxxxxx xxxxxx.

1xx) xxxxxxxx xxxxx xxxxxxxxxxx xxxxx xxxxxxxxxxxxx xxxxxxxx:

Xxxxx xxxxx xxxxxxxx:

Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum 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 xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 6X¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 6B¹ 4,4 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 7F¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 9X¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum xxxxxxxxx 14¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum xxxxxxxxx 18C¹ 2,2 µx

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 19A¹ 2,2 µx

Xxxxxxxxxxxx pneumoniae polysaccharidum xxxxxxxxx 19X¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum xxxxxxxxx 23F¹ 2,2 µx

¹ Xxxxxxxxxx x xxxxxx xxxxxxxxx XXX₁₉₇, xxxxxxxxxx xx xxxxxxxxxxx xxxxxxx.

Xxxxx dávka (0,5xx) xxxxxxxx xxxxxxxxx 32 µx nosného xxxxxxxx XXX₁₉₇ x 0,125 xx xxxxxxx.

1x) xxxxxxxx xxxxx proti záškrtu, xxxxxxxx kašli (acelulární xxxxx), xxxxxx, xxxxxx xxxxxxxx xxxxx (inaktivovaná xxxxx):

Xxxxx xxxxx (0,5 xx) xxxxxxxx:

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

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

Xxxxxxxxxxx xxxxxxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxxx¹ - 8 mikrogramů

Pertussis xxxxxxxxxxxxxx xxxxxxxxxxxx¹ - 8 xxxxxxxxxx

Xxxxxxxxx¹ 2,5 xxxxxxxxxx

Xxxxx xxxxxxxxxxxxxxx xxxxxxxxxxx:

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

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

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

¹ xxxxxxxxxxx na hydratovaný xxxxxxxx hlinitý (Al(OH)₃) 0,3 xxxxxxxxx Al³⁺ x xxxxxxxxxxx xxxxxxx (XxXX₄) 0,2 xxxxxxxxx Xx³⁺

² xxxxxxxxx xx XXXX xxxxxxx

XXXX

1xx) xxxxxxxx xxxxx proti xxxxxxx, xxxxxxxx xxxxx (xxxxxxxxxx xxxxx), xxxxxx, xxxxxx xxxxxxxx xxxxx (inaktivovaná xxxxx):

Xxxxx dávka (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx xxxxxxxxxx xxxxxxxxx 2 XX* (2,5 Lf)

Tetani xxxxxxxxxx xxxxxxxxx 20 IU* (5 Lf)

Pertusové xxxxxxxx:

Xxxxxxxxx xxxxxxxxxx 2,5 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxxxx filamentosum 5 xxxxxxxxxx

Xxxxxxxxxxx 3 xxxxxxxxxx

Xxxxxxxx, xxxx 2 et 3 5 mikrogramů

Virus xxxxxxxxxxxxxxx (inactivatum)**

typus 1 40 X xxxxxxxx xxxxxxxx

xxxxx 2 8 X xxxxxxxx xxxxxxxx

xxxxx 3 32 X xxxxxxxx xxxxxxxx

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

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

** Kultivováno xx Vero buňkách.

1j) xxxxxxxx xxxxx xxxxx xxxxxxxxxxx (BCG vakcína)

1k) xxxxxxxx xxxxx xxxxx xxxxxx xxxxxxxxxx B xxx osoby xxxxxxxx xx xxxxxxxxxxxx xxxxxxxx:

Xxxxx xxxxx (0,5 xx) xxxxxxx obsahuje:

Antigenum tegiminis xxxxxxxxxxx B^1,2,3 - 20 xxxxxxxxxx

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

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

³ xxxxxxxx xx kultuře xxxxxxxxxxxx xxxxx (Xxxxxxxxxxxxx xxxxxxxxxx) xxxxxxxxxxxxx DNA xxxxxxxxxxx.

2. Xxxxxxxxx xxxxxxx xxxxxxxxxx xxxxx xxx zvláštní xxxxxxxx

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

Xxxxx xxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxx hepatitidis X - 20 xxxxxxxxxx

2x) očkovací látka xxxxx xxxxxxxxx

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

Jedna xxxxx obsahuje:

Hepatitis A xxxxx inactivatum

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

Jedna xxxxx obsahuje:

Morbillorum xxxxx xxxxxxxxxx¹ (Schwarz) xxx. 10^3,0 xxxxxxxx xxxxx xxx buněčnou kulturu₅₀³

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

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

¹ xxxxxxxxx xx xxxxxxx xxxxxxxx xxxxxx

² xxxxxxxxx xx xxxxxxxx diploidních xxxxxxx (XXX-5)

³ 50 % xxxxxxxx xxxxx xxxxxxx xxxxxxx

XXXX

2xx) xxxxxxxx xxxxx xxxxx xxxxxxxxxx, xxxxxxxxxx x xxxxxxxxx

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

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

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

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

* 50 % xxxxxxxx xxxxx xxxxxxx kultury

¹ xxxxxxxx xx xxxxxxx xxxxxxxx xxxxxx

² xxxxxxxx xx xxxxxxxx xxxxxxxxxxx xxxxxxxx XX-38 xxxxxxxxxxxxx

3. Antigenní xxxxxxx xxxxxxxxxx xxxxx xxx mimořádná xxxxxxxx

3x) xxxxxxxx xxxxx xxxxx xxxxxx xxxxxxxxxx X xx xxxxxxx pro xxxxxxx:

Xxxxxxxxx X xxxxx xxxxxxxxxxx

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

Xxxxx xxxxxxxxx X xxxxxxxxxxx

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

Xxxxx xxxxx xxxxxxxx:

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

Xxxxxxxxxxx xxxxx attenuatum¹ (RIT 4385) xxx. 10^3,7 xxxxxxxx xxxxx pro xxxxxxxx xxxxxxx₅₀³

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

¹ pomnoženo xx xxxxxxx xxxxxxxx xxxxxx

² xxxxxxxxx xx xxxxxxxx xxxxxxxxxxx xxxxxxx (XXX-5)

³ 50 % xxxxxxxx dávka tkáňové xxxxxxx

XXXX

3xx) xxxxxxxx xxxxx xxxxx spalničkám, xxxxxxxxxx x zarděnkám

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

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

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

Xxxxx rubeolae² xxxxx xxxxxxxxxx (xxxx Xxxxxx XX 27/3) xx xxxx xxx 1x10³ XXXX₅₀*

* 50 % infekční dávka xxxxxxx kultury

¹ xxxxxxxx xx xxxxxxx xxxxxxxx xxxxxx

² vyrobeno na xxxxxxxx xxxxxxxxxxx xxxxxxxx XX-38 xxxxxxxxxxxxx. 

Xxxxxxx:

xxx. XXXx. Xxxxxx, Xx.X., x. x.

Xxxxxxxxx

Xxxxxx předpis č. 509/2020 Sb. xxxxx xxxxxxxxx xxxx 7.12.2020.

Xx xxx xxxxxxxx xxxxxx xxxxxxx nebyl xxxxx xx xxxxxxxxx.

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