Plné znění - 41/2023 Sb.

Sdělení Ministerstva zdravotnictví o antigenním složení očkovacích látek pro pravidelná, zvláštní a mimořádná očkování pro rok 2023

41/2023 Sb.
 

Sdělení Ministerstva zdravotnictví

INFORMACE

41

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Xxxxxxxxxxxx xxxxxxxxxxxxx

xx xxx 10. xxxxx 2023

o xxxxxxxxxx xxxxxxx xxxxxxxxxx xxxxx xxx pravidelná, xxxxxxxx x xxxxxxxxx xxxxxxxx xxx xxx 2023
&xxxx;

Xxxxxxxxxxxx xxxxxxxxxxxxx podle §80 xxxx. 1 xxxx. x) xxxxxx x. 258/2000 Xx., x ochraně xxxxxxxxx xxxxxx x x xxxxx některých xxxxxxxxxxxxx xxxxxx, xx znění xxxxxxxxxx předpisů, xxxxxxx xx základě xxxxxxxxxx Xxxxxxx xxxxxxxxxx xxxxxx xxxxxxxxx xxxxxxx očkovacích xxxxx xxx xxxxxxxxxx, xxxxxxxx x xxxxxxxxx xxxxxxxx xxx xxx 2023:

1. Antigenní xxxxxxx xxxxxxxxxx látek xxx xxxxxxxxxx xxxxxxxx

1x) xxxxxxxxxxx xxxxxxxx xxxxx xxxxx xxxxxxx, xxxxxxxx xxxxx (xxxxxxxxxx forma), xxxxxx, xxxxxx xxxxxxxx obrně (xxxxxxxxxxxx forma), xxxxxx xxxxxxxxxx X, xxxxxxx xxxxxxxxx Haemophilus influenzae xxx b (XXxXXxxXXXXXX)

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

Xxxxxxxxxxx xxxxxxxxxx¹ ne xxxx xxx 30 xxxxxxxxxxxxx xxxxxxxx (IU)

Tetani xxxxxxxxxx¹ xx xxxx xxx 40 mezinárodních jednotek (XX)

Xxxxxxxx Bordetelly xxxxxxxxx:

Xxxxxxxxx xxxxxxxxxx (XX)¹ 25 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxxxx xxxxxxxxxxxx (XXX)1 25 xxxxxxxxxx Xxxxxxxxxxx (XXX)¹ 8 xxxxxxxxxx

Xxxxxxxxx tegiminis hepatitidis X (HBs)^2,3 10 xxxxxxxxxx

Xxxxx poliomyelitidis xxxxxxxxxxx (XXX)

xxxxx 1 (xxxx Xxxxxxx)⁴ 40 D xxxxxxxx xxxxxxxx

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

xxxxx 3 (xxxx Saukett)⁴ 32 D xxxxxxxx xxxxxxxx

Xxxxxxxxxxx influenzae typus x xxxxxxxxxxxxxxx

(Xxxxxxxxxxxxxxxxxxx phosphas) 10 mikrogramů

conj. cum xxxxxx. xxxxxxxx xxxx xxxxx xxxxxxx xxxxxxxxx 25 xxxxxxxxxx

¹ adsorbováno xx xxxxxxxx xxxxxxx, xxxxxxxxxxx (Xx(XX)₃) 0,5 xxxxxxxxx Al³⁺

² xxxxxxxx xxxxxxxxxxxxx XXX xxxxxxxxxxx xx xxxxxxx xxxxxxxxxxxx xxxxx Xxxxxxxxxxxxx xxxxxxxxxx)

³ xxxxxxxxxxx na xxxxxxxxxxx xxxxxxx (XxXX₄) 0,32 xxxxxxxxx Al³⁺

⁴ pomnoženo xx XXXX buňkách

NEBO

1aa) xxxxxxxxxxx očkovací xxxxx xxxxx xxxxxxx, dávivému xxxxx (acelulární xxxxx), xxxxxx, xxxxxx xxxxxxxx xxxxx (xxxxxxxxxxxx xxxxx), xxxxxx hepatitidě B, xxxxxxx xxxxxxxxx Haemophilus xxxxxxxxxx typ x (XXxXXxxXXXXXX)

Xxxxx xxxxx¹ (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx xxxxxxxxxx xx xxxx xxx 20 mezinárodních xxxxxxxx (XX)²

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

Xxxxxxxx Xxxxxxxxxx pertussis

Pertussis anatoxinum 25 xxxxxxxxxx

Xxxxxxxxxxxxxx xxxxxxxxxxxx 25 xxxxxxxxxx

Xxxxx Xxxxxxxxxxxxxxx (xxxxxxxxxxxx)³

xxxxx 1 (Mahoney) 40 X xxxxxxxx xxxxxxxx⁴

xxxxx 2 (XXX-1) 8 X xxxxxxxx xxxxxxxx⁴

xxxxx 3 (Xxxxxxx) 32 X xxxxxxxx xxxxxxxx⁴

Xxxxxxxxx tegiminis hepatitidis X⁵ 10 xxxxxxxxxx

Xxxxxxxxxxxxxxxxxxx xxxxxxxx xxxxxxxxxx xxxxxxxxxx X 12 xxxxxxxxxx

(Xxxxxxxxxxxxxxxxxxx xxxxxxxx)

xxxxxxxxx cum tetani xxxxxxxxxx 22-36 xxxxxxxxxx

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

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

³ xxxxxxxxx xx XXXX xxxxxxx

⁴ nebo ekvivalentní xxxxxxxx antigenu xxxxxxxxx xxxxxxx xxxxxxxxxxxxxx xxxxxxx

⁵ xxxxxxxx xxxxxxxxxxxxx DNA xxxxxxxxxxx x xxxxxxxxxxxx xxxxxxx Xxxxxxxxx xxxxxxxxxx

XXXX

1xx) Xxxxxxx xxxxx xxxxxxx, xxxxxx, xxxxxxxx kašli (xxxxxxxxxx komponenta), hepatitidě X (xXXX), xxxxxx xxxxxxxx xxxxx (xxxxxxxxxxxx) x konjugovaná xxxxxxx xxxxx Xxxxxxxxxxx xxxx x (xxxxxxxxxxx)

Xxxxx xxxxx (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx xxxxxxxxxx¹ xx xxxx xxx 20 XX

Xxxxxx xxxxxxxxxx¹ ne méně xxx 40 XX

Xxxxxxxx Xxxxxxxxxxx pertusis¹

Pertussis anatoxinum (XX) 20 mikrogramů

Haemagglutinium xxxxxxxxxxxx (XXX) 20 xxxxxxxxxx

Xxxxxxxxxxx (XXX) 3 xxxxxxxxxx

Xxxxxxxx xxxx 2 xx 3 (FIM) 5 xxxxxxxxxx

Xxxxxxxxx tegiminis xxxxxxxxxxx B^2,3 10 xxxxxxxxxx

Xxxxx poliomyelitidis (xxxxxxxxxxx)⁴

Xxxxx 1 (Xxxxxxx) 40 X xxxxxxxx xxxxxxxx⁵

Xxxxx 2 (XXX-1) 8 X jednotek xxxxxxxx⁵

Xxxxx 3 (Xxxxxxx) 32 X jednotek xxxxxxxx⁵

Xxxxxxxxxxxxxx Xxxxxxxxxx xxxxxxxxxx typus x

(Xxxxxxxxxxxxxxxxxxx xxxxxxxx) 3 xxxxxxxxxx xxxxxxxxxx xxx xxxxxxxxx meningococci typus x² 50 xxxxxxxxxx

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

² adsorbováno na xxxxxxxxxxx xxxxxxxx xxxxxxx xxxxxx (0,15 xx Xx³⁺)

³ xxxxxxxx xxxxxxxxxxxxx XXX xxxxxxxxxxx x xxxxxxxxxxxx xxxxxxx Xxxxxxxxxxxxx xxxxxxxxxx

⁴ xxxxxxxxx xx Xxxx xxxxxxx

⁵ xxxx xxxxxxxxxxxx xxxxxxxx antigenu xxxxxxxxx xxxxxxx imunochemickou xxxxxxx.

1x) xxxxxxxx xxxxx xxxxx xxxxxxx, dávivému xxxxx (acelulární forma), xxxxxx (DTaP)

Jedna xxxxx (0,5 ml) xxxxxxxx xxxx xxxxxx xxxxx:

Xxxxxxxxxxx xxxxxxxxxx* ≥ 30 XX

Xxxxxx xxxxxxxxxx* ≥ 40 XX

Xxxxxxxxx anatoxinum* (XX) 25 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxxx filamentosum* (FHA) 25 xxxxxxxxxx

Xxxxxxxxxxx* (69 xX) 8 xxxxxxxxxx

* xxxxxxxxxxx xx xxxxxxxx xxxxxxx celkem: 0,5 xxxxxxxxx

XXXX

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

Xxxxx xxxxx (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx xxxxxxxxxx - Xxxxxxxxx 2 XX* (2 Xx)

Xxxxxx xxxxxxxxxx - Minimálně 20 XX* (5 Xx)

Xxxxxxxxx xxxxxxxx

Xxxxxxxxx xxxxxxxxxx - 2,5 xxxxxxxxxx

Xxxxxxxxxxxxxx xxxxxxxxxxxx - 5 xxxxxxxxxx

Xxxxxxxxxxx - 3 xxxxxxxxxx

Xxxxxxxx, xxxx 2 xx 3 - 5 xxxxxxxxxx

Xxxxxxxxxxx xx fosforečnan xxxxxxx - 1,5 xx (0,33 mg xxxxxxx)

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

XXXX

1xx) Očkovací xxxxx proti záškrtu, xxxxxx x dávivému xxxxx (xxxxxxxxxx xxxxxxxxxx) xx xxxxxxxx xxxxxxx xxxxxxxx (Xxxx)

Xxxxx xxxxx (0,5 xx) obsahuje:

Diphtheriae xxxxxxxxxx¹ xx méně xxx 2 mezinárodní xxxxxxxx (XX) (2,5 Xx)

Xxxxxx xxxxxxxxxx¹ xx xxxx než 20 xxxxxxxxxxxxx jednotek (XX) (5 Lf)

Bordetellae pertussis xxxxxxxx:

Xxxxxxxxx anatoxinum¹ 8 xxxxxxxxxx

Xxxxxxxxx haemagglutinum xxxxxxxxxxxx¹ 8 mikrogramů

Pertussis membranae xxxxxxxx xxxxxxxxx¹ 2,5 xxxxxxxxxx

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

1c) očkovací xxxxx proti nákazám xxxxxxxxx Xxxxxxxxxxx influenzae xxx b:

Jedna xxxxx xxxxxxxxxxxxx xxxxxxx xxxxxxxx:

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

1x) xxxxxxxx xxxxx xxxxx xxxxxx:

Xxxxx dávka xxxxxxxx:

Xxxxxx xxxxxxxxxx - xxx. 40 xxxxxxxxxxxxx xxxxxxxx

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

Xxxxx xxxxx obsahuje:

Antigenum xxxxxxxxx xxxxxxxxxxx X - 10 xxxxxxxxxx

1x) xxxxxxxx látka xxxxx xxxxxx xxxxxxxxxx B x dospělé xxxxxxx

Xxxxx xxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx B - 20 mikrogramů

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

Xxxxx xxxxx xxxxxxxx:

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

Parotitidis xxxxx attenuatum¹ (RIT 4385) min. 10^3,0 xxxxxxxx xxxxx xxx xxxxxxxx xxxxxxx₅₀³

Xxxxxxxx xxxxx xxxxxxxxxx² (Wistar RA 27/3) xxx. 10^3,0 xxxxxxxx xxxxx xxx xxxxxxxx xxxxxxx₅₀³

¹ xxxxxxxxx xx xxxxxxx xxxxxxxx xxxxxx

² pomnoženo xx xxxxxxxx xxxxxxxxxxx buňkách (XXX-5)

³ 50% infekční xxxxx tkáňové kultury

NEBO

1ga) xxxxxxxx xxxxx xxxxx xxxxxxxxxx, příušnicím x xxxxxxxxx

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

Xxxxx xxxxxxxxxxx¹ xxxxx xxxxxxxxxx (xxxx Enders’ Xxxxxxxxx) ne méně xxx 1x10³ CCID₅₀*

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

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

* 50 % xxxxxxxx xxxxx xxxxxxx xxxxxxx

¹ vyrobeno xx xxxxxxx xxxxxxxx xxxxxx.

² xxxxxxxx xx lidských xxxxxxxxxxx xxxxxxxx XX-38 xxxxxxxxxxxxx.

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

Xxxxx xxxxx xxxxxxxx:

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

Virus xxxxxxxxxxxxx xxxxxxxxxxx xxxxx 2 (XXX-1) ..........8 xxxxxxxxxxx X xxxxxxxx*

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

* xxxx xxxxxxxx xxxxxxxxxxxxxx antigenů xxxxxxxxx xxxxxx xxxxxx imunochemické xxxxxx.

1xx) xxxxxxxx xxxxx xxxxx xxxxxxxxxxxxx xxxxxxxx xxxxxxxxx x xxxxxxxxxx xxxxxxxx:

1xxx) xxxxxxxxxxx xxxxxxxx xxxxx xxxxxxxx:

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 1¹ 2,2 µg

Streptococci xxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 3¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 4¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 5¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 6X¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 6X¹ 4,4 µg

Streptococci pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 7X¹ 2,2 µg

Streptococci xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 9V¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 14¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 18C¹ 2,2 µg

Streptococci xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 19A¹ 2,2 µg

Streptococci xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 19F¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 23F¹ 2,2 µx

¹ Xxxxxxxxxx x nosným proteinem XXX197 x xxxxxxxxxx xx xxxxxxxxxxx hlinitý (0,125 mg xxxxxxx).

1xxx) xxxxxxxxxxxxxxx xxxxxxxx xxxxx xxxxxxxx:

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

1x) xxxxxxxx xxxxx xxxxx záškrtu, xxxxxxxx xxxxx (xxxxxxxxxx forma), xxxxxx, xxxxxx xxxxxxxx xxxxx (xxxxxxxxxxxx forma):

Jedna xxxxx (0,5 ml) xxxxxxxx:

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

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

Xxxxxxxxxxx xxxxxxxxx xxxxxxxx:

Xxxxxxxxx anatoxinum¹ - 8 mikrogramů

Pertussis xxxxxxxxxxxxxx xxxxxxxxxxxx¹ - 8 xxxxxxxxxx

Xxxxxxxxx1 2,5 xxxxxxxxxx

Xxxxx xxxxxxxxxxxxxxx xxxxxxxxxxx:

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

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

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

¹ Adsorbováno xx xxxxxxxxxxx hydroxid xxxxxxx (Xx(XX)₃) 0,3 xxxxxxxxx Al³⁺ a xxxxxxxxxxx xxxxxxx (AlPO₄) 0,2 xxxxxxxxx Al³⁺

² xxxxxxxxx xx XXXX xxxxxxx

XXXX

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

Xxxxx xxxxx (0,5 ml) xxxxxxxx:

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

Xxxxxx anatoxinum xxxxxxxxx 20 XX* (5 Xx)

Xxxxxxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxxx 2,5 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxxxx xxxxxxxxxxxx 5 xxxxxxxxxx

Xxxxxxxxxxx 3 xxxxxxxxxx

Xxxxxxxx, typi 2 xx 3 5 xxxxxxxxxx

Xxxxx poliomyelitidis (xxxxxxxxxxx)**

xxxxx 1 40 X jednotek xxxxxxxx

xxxxx 2 8 D xxxxxxxx xxxxxxxx

xxxxx 3 32 X jednotek xxxxxxxx

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

* Xxxx xxxxxx xxxxxxx xxxxxxxxx spolehlivosti (x = 0,95) xxxxxxxx xxxxxx xxxxx xxxxx xxxxxxxxx v Evropském xxxxxxxx.

** Xxxxxxxxxxx xx Xxxx xxxxxxx.

1x) očkovací xxxxx proti xxxxxxxxxxx (XXX xxxxxxx)

1x) xxxxxxxx xxxxx xxxxx xxxxxx xxxxxxxxxx X pro xxxxx xxxxxxxx do xxxxxxxxxxxx programu:

Jedna dávka (0,5 ml) vakcíny xxxxxxxx:

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

¹ adjuvovaný xx XX04X xxxxxxxxxx: - 3-0-xxxxxx-4'-xxxxxxxxxxxx-xxxxx A (XXX)² 50 xxxxxxxxxx

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

³ vyrobeno xx xxxxxxx xxxxxxxxxxxx buněk (Xxxxxxxxxxxxx xxxxxxxxxx) rekombinantní XXX xxxxxxxxxxx.

2. Xxxxxxxxx xxxxxxx xxxxxxxxxx xxxxx xxx xxxxxxxx očkování

2a) xxxxxxxx xxxxx xxxxx xxxxxx xxxxxxxxxx B xx xxxxxxx xxx xxxxxxx:

Xxxxx xxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxx hepatitidis X - 20 xxxxxxxxxx

2x) xxxxxxxx xxxxx xxxxx xxxxxxxxx

2x) očkovací xxxxx xxxxx xxxxxx xxxxxxxxxx X xx xxxxxxx xxx dospělé:

Jedna dávka xxxxxxxx:

Xxxxxxxxx X xxxxx xxxxxxxxxxx

2x) očkovací látka xxxxx xxxxxxxxxx, xxxxxxxxxx x zarděnkám:

Jedna dávka xxxxxxxx:

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

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

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

¹ xxxxxxxxx na xxxxxxx xxxxxxxx xxxxxx

² xxxxxxxxx na xxxxxxxx xxxxxxxxxxx xxxxxxx (XXX-5)

³ 50% infekční xxxxx xxxxxxx xxxxxxx

XXXX

2xx) xxxxxxxx xxxxx xxxxx xxxxxxxxxx, xxxxxxxxxx x xxxxxxxxx

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

Xxxxx xxxxxxxxxxx¹ xxxxx xxxxxxxxxx (xxxx Enders’ Xxxxxxxxx) xx méně než 1x10³ XXXX₅₀*

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

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

* 50 % infekční xxxxx xxxxxxx xxxxxxx

¹ xxxxxxxx xx xxxxxxx xxxxxxxx embryí.

² xxxxxxxx xx xxxxxxxx xxxxxxxxxxx xxxxxxxx XX-38 fibroblastech.

3. Xxxxxxxxx složení xxxxxxxxxx xxxxx xxx xxxxxxxxx xxxxxxxx

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

Xxxxx xxxxxxxxx X xxxxxxxxxxx

3x) xxxxxxxx xxxxx xxxxx xxxxxx xxxxxxxxxx A ve xxxxxxx xxx xxxx:

Xxxxx xxxxxxxxx A xxxxxxxxxxx

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

Xxxxx xxxxx xxxxxxxx:

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

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

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

¹ xxxxxxxxx xx xxxxxxx xxxxxxxx embryí

² xxxxxxxxx xx xxxxxxxx xxxxxxxxxxx xxxxxxx (XXX-5)

³ 50% xxxxxxxx xxxxx xxxxxxx xxxxxxx

XXXX

3xx) xxxxxxxx látka xxxxx xxxxxxxxxx, xxxxxxxxxx x zarděnkám

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

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

Xxxxx xxxxxxxxxxx¹ xxxxx xxxxxxxxxx (kmen Xxxxx Xxxx™, xxxxxxx B) xx méně xxx 12,5x10³ CCID₅₀³

Virus rubeolae² xxxxx xxxxxxxxxx (kmen Xxxxxx XX 27/3) xx xxxx než 1x110³ CCID₅₀³

* 50% xxxxxxxx xxxxx xxxxxxx xxxxxxx

¹ xxxxxxxx xx xxxxxxx xxxxxxxx xxxxxx.

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

Xxxxxxx:

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

Informace

Právní předpis č. 41/2023 Xx. xxxxx xxxxxxxxx xxxx 22.2.2023.

Xx xxx uzávěrky xxxxxx xxxxxxx xxxxx xxxxx xx xxxxxxxxx.

Xxxxx xxxxxxxxxxxx xxxxxxxx norem xxxxxx xxxxxxxx xxxxxxxx v xxxxxxxx xxxx xxxxxxxxxxxxx, xxxxx xx xxxx xxxxxx derogační změna xxxxx uvedeného xxxxxxxx xxxxxxxx.