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

x xxxxxxxxxx složení xxxxxxxxxx xxxxx xxx xxxxxxxxxx, xxxxxxxx x xxxxxxxxx xxxxxxxx pro xxx 2021

 

Xxxxxxxxxxxx xxxxxxxxxxxxx xxxxx §80 odst. 1 xxxx. e) xxxxxx x. 258/2000 Xx., x ochraně veřejného xxxxxx x x xxxxx xxxxxxxxx souvisejících xxxxxx, xx xxxxx xxxxxxxxxx xxxxxxxx, xxxxxxx xx základě xxxxxxxxxx Xxxxxxx xxxxxxxxxx komise xxxxxxxxx xxxxxxx xxxxxxxxxx xxxxx xxx xxxxxxxxxx, xxxxxxxx x mimořádná xxxxxxxx xxx rok 2021:

1. Xxxxxxxxx xxxxxxx xxxxxxxxxx xxxxx xxx xxxxxxxxxx xxxxxxxx

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

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

Xxxxxxxxxxx xxxxxxxxxx¹ xx xxxx xxx 30 mezinárodních xxxxxxxx (XX)

Xxxxxx xxxxxxxxxx¹ xx méně než 40 mezinárodních jednotek (XX)

Xxxxxxxx Xxxxxxxxxx xxxxxxxxx:

Xxxxxxxxx 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 (IPV)

typus 1 (kmen Xxxxxxx)⁴ 40 X xxxxxxxx xxxxxxxx

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

typus 3 (xxxx Xxxxxxx)⁴ 32 X jednotek antigenu

Haemophilus xxxxxxxxxx xxxxx x xxxxxxxxxxxxxxx

(Xxxxxxxxxxxxxxxxxxx xxxxxxxx) 10 xxxxxxxxxx

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

¹ xxxxxxxxxxx xx xxxxxxxx hlinitý, xxxxxxxxxxx (Xx(XX)₃) 0,5 miligramů Xx³⁺

² vyrobeno xxxxxxxxxxxxx XXX technologií xx xxxxxxx kvasinkových xxxxx (Xxxxxxxxxxxxx cerevisiae)

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

⁴ pomnoženo xx XXXX buňkách

NEBO

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

Xxxxx xxxxx¹ (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx xxxxxxxxxx xx xxxx xxx 20 xxxxxxxxxxxxx jednotek (XX)²

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

Xxxxxxxx Bordetelly xxxxxxxxx

Xxxxxxxxx anatoxinum 25 xxxxxxxxxx

Xxxxxxxxxxxxxx xxxxxxxxxxxx 25 xxxxxxxxxx

Xxxxx Xxxxxxxxxxxxxxx (xxxxxxxxxxxx)³

xxxxx 1 (Xxxxxxx) 40 X xxxxxxxx antigenu⁴

typus 2 (XXX-1) 8 X xxxxxxxx xxxxxxxx⁴

xxxxx 3 (Xxxxxxx) 32 X xxxxxxxx antigenu⁴

Antigenum xxxxxxxxx xxxxxxxxxxx B⁵ 10 mikrogramů

Polyribosylribitoli phosphas xxxxxxxxxx xxxxxxxxxx X 12 xxxxxxxxxx

(Xxxxxxxxxxxxxxxxxxx xxxxxxxx)

xxxxxxxxx xxx tetani xxxxxxxxxx 22-36 xxxxxxxxxx

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

² jako xxxxxx xxx xxxxxxxxxxxxx (p = 0,95)

³ xxxxxxxxx xx XXXX xxxxxxx

⁴ xxxx ekvivalentní množství xxxxxxxx xxxxxxxxx xxxxxxx xxxxxxxxxxxxxx xxxxxxx

⁵ vyrobeno xxxxxxxxxxxxx XXX xxxxxxxxxxx x kvasinkových xxxxxxx Xxxxxxxxx xxxxxxxxxx

XXXX

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

Xxxxx dávka (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx xxxxxxxxxx¹ xx méně xxx 20 XX

Xxxxxx anatoxinum¹ xx xxxx xxx 40 XX

Xxxxxxxx Xxxxxxxxxxx xxxxxxxx¹

Xxxxxxxxx anatoxinum (XX) 20 xxxxxxxxxx

Xxxxxxxxxxxxxxx xxxxxxxxxxxx (XXX) 20 xxxxxxxxxx

Xxxxxxxxxxx (XXX) 3 xxxxxxxxxx

Xxxxxxxx xxxx 2 xx 3 (XXX) 5 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx X^2,3 10 mikrogramů

Virus xxxxxxxxxxxxxxx (xxxxxxxxxxx)⁴

Xxxxx 1 (Xxxxxxx) 40 X xxxxxxxx xxxxxxxx⁵

Xxxxx 2 (XXX-1) 8 X xxxxxxxx xxxxxxxx⁵

Xxxxx 3 (Xxxxxxx) 32 X xxxxxxxx antigenu⁵

Polysaccharidi Xxxxxxxxxx xxxxxxxxxx xxxxx x

(Xxxxxxxxxxxxxxxxxxx xxxxxxxx) 3 xxxxxxxxxx xxxxxxxxxx cum proteinům xxxxxxxxxxxx xxxxx b² 50 mikrogramů

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

² xxxxxxxxxxx na xxxxxxxxxxx xxxxxxxx hlinitý xxxxxx (0,15 mg Al³⁺)

³ xxxxxxxx xxxxxxxxxxxxx XXX xxxxxxxxxxx v xxxxxxxxxxxx xxxxxxx Saccharomyces xxxxxxxxxx

⁴ xxxxxxxxx xx Xxxx xxxxxxx

⁵ nebo xxxxxxxxxxxx xxxxxxxx xxxxxxxx xxxxxxxxx xxxxxxx imunochemickou metodou.

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

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

Diphtheriae xxxxxxxxxx* ≥ 30 XX

Xxxxxx xxxxxxxxxx* ≥ 40 XX

Xxxxxxxxx xxxxxxxxxx* (XX) 25 mikrogramů

Pertussis xxxxxxxxxxxxxxx xxxxxxxxxxxx* (XXX) 25 xxxxxxxxxx

Xxxxxxxxxxx* (69kD) 8 xxxxxxxxxx

* xxxxxxxxxxx xx xxxxxxxx hlinitý xxxxxx: 0,5 xxxxxxxxx

XXXX

1xx) Očkovací xxxxx proti záškrtu, xxxxxx x dávivému xxxxx (acelulární) se xxxxxxxx obsahem xxxxxxxx (Xxxx)

Xxxxx xxxxx (0,5 xx) obsahuje:

Diphtheriae 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 xxxxxxxxxx

Xxxxxxxx, xxxx 2 xx 3 - 5 mikrogramů

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

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

XXXX

1xx) Xxxxxxxx xxxxx xxxxx xxxxxxx, tetanu x xxxxxxxx kašli (xxxxxxxxxx xxxxxxxxxx) xx xxxxxxxx xxxxxxx xxxxxxxx (Tdap)

Jedna xxxxx (0,5 ml) xxxxxxxx:

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

Tetani xxxxxxxxxx¹ xx xxxx než 20 xxxxxxxxxxxxx jednotek (XX) (5 Xx)

Xxxxxxxxxxx xxxxxxxxx xxxxxxxx:

Xxxxxxxxx anatoxinum¹ 8 mikrogramů

Pertussis xxxxxxxxxxxxxx xxxxxxxxxxxx¹ 8 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxx xxxxxxx proteinům¹ 2,5 xxxxxxxxxx

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

1x) xxxxxxxx xxxxx proti xxxxxxx vyvolaným Xxxxxxxxxxx xxxxxxxxxx xxx b:

Jedna xxxxx xxxxxxxxxxxxx vakcíny xxxxxxxx:

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

1x) xxxxxxxx xxxxx proti tetanu:

Jedna xxxxx xxxxxxxx:

Xxxxxx xxxxxxxxxx - xxx. 40 xxxxxxxxxxxxx xxxxxxxx

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

Xxxxx xxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxx hepatitidis X - 10 xxxxxxxxxx

1x) očkovací xxxxx xxxxx virové xxxxxxxxxx X v xxxxxxx xxxxxxx

Xxxxx dávka xxxxxxxx:

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx X - 20 mikrogramů

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

Xxxxx dávka xxxxxxxx:

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

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

Xxxxxxxx xxxxx xxxxxxxxxx² (Wistar XX 27/3) xxx. 10^3,0 infekční dávka xxx buněčnou kulturu₅₀³

¹ xxxxxxxxx na buňkách xxxxxxxx embryí

² pomnoženo xx xxxxxxxx xxxxxxxxxxx xxxxxxx (MRC-5)

³ 50 % xxxxxxxx dávka xxxxxxx xxxxxxx

XXXX

1xx) očkovací xxxxx proti xxxxxxxxxx, xxxxxxxxxx x xxxxxxxxx

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

Xxxxx xxxxxxxxxxx¹ vivum attenuatum (xxxx Xxxxxx’ Edmonston) xx méně než 1x10³ CCID₅₀*

Virus parotitidis¹ xxxxx xxxxxxxxxx (xxxx Xxxxx Xxxx^XX, xxxxxxx X) ne xxxx xxx 12,5x10³ XXXX₅₀*

Xxxxx xxxxxxxx² xxxxx xxxxxxxxxx (xxxx Xxxxxx RA 27/3) xx xxxx xxx 1x10³ CCID₅₀*

* 50 % infekční xxxxx xxxxxxx xxxxxxx

¹ xxxxxxxx xx xxxxxxx xxxxxxxx xxxxxx.

² xxxxxxxx xx xxxxxxxx xxxxxxxxxxx xxxxxxxx WI-38 xxxxxxxxxxxxx.

1x) xxxxxxxx xxxxx xxxxx xxxxxx xxxxxxxx xxxxx x inaktivované xxxxx:

Xxxxx xxxxx xxxxxxxx:

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

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

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

* xxxx xxxxxxxx xxxxxxxxxxxxxx antigenů xxxxxxxxx pomocí vhodné xxxxxxxxxxxxx metody.

1ch) xxxxxxxx xxxxx xxxxxxxxxxx xxxxx xxxxxxxxxxxxx xxxxxxxx:

Xxxxx xxxxx xxxxxxxx:

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 1¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx 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 6A¹ 2,2 µx

Xxxxxxxxxxxx pneumoniae polysaccharidum xxxxxxxxx 6X¹ 4,4 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 7X¹ 2,2 µx

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 9V¹ 2,2 µx

Xxxxxxxxxxxx pneumoniae 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 xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 23X¹ 2,2 µx

¹ Xxxxxxxxxx x xxxxxx xxxxxxxxx XXX₁₉₇, xxxxxxxxxx na fosforečnan xxxxxxx.

Xxxxx xxxxx (0,5xx) xxxxxxxx xxxxxxxxx 32 µx xxxxxxx proteinu XXX₁₉₇ a 0,125 xx xxxxxxx.

1x) očkovací xxxxx proti xxxxxxx, xxxxxxxx xxxxx (acelulární xxxxx), xxxxxx, dětské xxxxxxxx obrně (xxxxxxxxxxxx xxxxx):

Xxxxx xxxxx (0,5 xx) obsahuje:

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

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

Bordetellae xxxxxxxxx xxxxxxxx:

Xxxxxxxxx anatoxinum¹ - 8 mikrogramů

Pertussis xxxxxxxxxxxxxx filamentosum¹ - 8 xxxxxxxxxx

Xxxxxxxxx¹ 2,5 xxxxxxxxxx

Xxxxx xxxxxxxxxxxxxxx xxxxxxxxxxx:

xxxxx 1 (xxxx Mahoney)² - 40 D xxxxxxxx xxxxxxxx

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

xxxxx 3 (kmen Xxxxxxx)² - 32 X jednotek antigenů

¹ xxxxxxxxxxx xx hydratovaný xxxxxxxx hlinitý (Xx(XX)₃) 0,3 xxxxxxxxx Al³⁺ x xxxxxxxxxxx xxxxxxx (XxXX₄) 0,2 xxxxxxxxx Xx³⁺

² pomnoženo xx XXXX buňkách

NEBO

1ia) xxxxxxxx xxxxx xxxxx xxxxxxx, xxxxxxxx xxxxx (xxxxxxxxxx xxxxx), tetanu, xxxxxx xxxxxxxx xxxxx (inaktivovaná xxxxx):

Xxxxx xxxxx (0,5 xx) xxxxxxxx:

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

Xxxxxx xxxxxxxxxx xxxxxxxxx 20 XX* (5 Xx)

Xxxxxxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxxx 2,5 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxxxx filamentosum 5 xxxxxxxxxx

Xxxxxxxxxxx 3 xxxxxxxxxx

Xxxxxxxx, xxxx 2 xx 3 5 mikrogramů

Virus xxxxxxxxxxxxxxx (xxxxxxxxxxx)**

xxxxx 1 40 X jednotek xxxxxxxx

xxxxx 2 8 X xxxxxxxx xxxxxxxx

xxxxx 3 32 X xxxxxxxx xxxxxxxx

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

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

** Kultivováno xx Vero xxxxxxx.

1x) xxxxxxxx látka xxxxx xxxxxxxxxxx (BCG vakcína)

1k) xxxxxxxx xxxxx proti xxxxxx hepatitidě X xxx osoby xxxxxxxx xx xxxxxxxxxxxx xxxxxxxx:

Xxxxx xxxxx (0,5 xx) xxxxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxx 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 na xxxxxxxxxxx xxxxxxx (xxxxxx 0,5 xxxxxxxxx Xx³⁺)

³ vyrobeno xx kultuře xxxxxxxxxxxx xxxxx (Saccharomyces xxxxxxxxxx) xxxxxxxxxxxxx XXX xxxxxxxxxxx.

2. Xxxxxxxxx složení xxxxxxxxxx xxxxx pro xxxxxxxx xxxxxxxx

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

Xxxxx xxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxx hepatitidis X - 20 xxxxxxxxxx

2x) xxxxxxxx xxxxx xxxxx xxxxxxxxx

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

Xxxxx xxxxx obsahuje:

Hepatitis A xxxxx xxxxxxxxxxx

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

Xxxxx xxxxx xxxxxxxx:

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

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

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

¹ xxxxxxxxx xx xxxxxxx xxxxxxxx xxxxxx

² pomnoženo na xxxxxxxx xxxxxxxxxxx buňkách (XXX-5)

³ 50 % xxxxxxxx xxxxx xxxxxxx xxxxxxx

XXXX

2xx) xxxxxxxx xxxxx xxxxx spalničkám, příušnicím x xxxxxxxxx

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

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

Xxxxx xxxxxxxxxxx¹ xxxxx xxxxxxxxxx (xxxx Xxxxx Xxxx™, xxxxxxx X) xx méně xxx 12,5x10³ CCID₅₀*

Virus xxxxxxxx² xxxxx xxxxxxxxxx (kmen Xxxxxx XX 27/3) xx xxxx než 1x10³ CCID₅₀*

* 50 % xxxxxxxx xxxxx xxxxxxx xxxxxxx

¹ vyrobeno xx xxxxxxx xxxxxxxx xxxxxx

² vyrobeno na xxxxxxxx xxxxxxxxxxx plicních XX-38 xxxxxxxxxxxxx

3. Antigenní xxxxxxx očkovacích xxxxx xxx xxxxxxxxx očkování

3a) xxxxxxxx xxxxx proti xxxxxx hepatitidě X xx formuli xxx xxxxxxx:

Xxxxxxxxx X virus xxxxxxxxxxx

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

Xxxxx hepatitis X xxxxxxxxxxx

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

Xxxxx xxxxx xxxxxxxx:

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

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

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

¹ xxxxxxxxx xx xxxxxxx kuřecích xxxxxx

² pomnoženo xx xxxxxxxx diploidních xxxxxxx (XXX-5)

³ 50 % xxxxxxxx xxxxx xxxxxxx xxxxxxx

XXXX

3xx) xxxxxxxx xxxxx xxxxx xxxxxxxxxx, příušnicím x zarděnkám

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

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

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

Xxxxx xxxxxxxx² xxxxx xxxxxxxxxx (xxxx Xxxxxx XX 27/3) xx méně než 1x10³ CCID₅₀*

* 50 % xxxxxxxx xxxxx xxxxxxx xxxxxxx

¹ xxxxxxxx xx xxxxxxx kuřecích xxxxxx

² xxxxxxxx na xxxxxxxx xxxxxxxxxxx plicních XX-38 xxxxxxxxxxxxx. 

Xxxxxxx:

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

Xxxxxxxxx

Xxxxxx xxxxxxx x. 509/2020 Xx. xxxxx xxxxxxxxx dnem 7.12.2020.

Ke xxx uzávěrky xxxxxx xxxxxxx xxxxx měněn xx xxxxxxxxx.

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