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

XXXXXXX

Xxxxxxxxxxxx xxxxxxxxxxxxx

xx dne 10. xxxxx 2023

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

Xxxxxxxxxxxx zdravotnictví podle §80 xxxx. 1 xxxx. x) xxxxxx x. 258/2000 Sb., x xxxxxxx veřejného xxxxxx x x xxxxx některých xxxxxxxxxxxxx xxxxxx, ve xxxxx xxxxxxxxxx xxxxxxxx, xxxxxxx xx xxxxxxx xxxxxxxxxx Xxxxxxx xxxxxxxxxx xxxxxx xxxxxxxxx xxxxxxx xxxxxxxxxx xxxxx xxx xxxxxxxxxx, xxxxxxxx a xxxxxxxxx xxxxxxxx xxx xxx 2023:

1. Xxxxxxxxx xxxxxxx xxxxxxxxxx látek pro xxxxxxxxxx xxxxxxxx

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

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

Xxxxxxxxxxx xxxxxxxxxx¹ xx méně xxx 30 xxxxxxxxxxxxx xxxxxxxx (IU)

Tetani xxxxxxxxxx¹ xx méně xxx 40 mezinárodních xxxxxxxx (XX)

Xxxxxxxx Xxxxxxxxxx xxxxxxxxx:

Xxxxxxxxx xxxxxxxxxx (XX)¹ 25 xxxxxxxxxx

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

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

Xxxxx xxxxxxxxxxxxxxx inactivatum (XXX)

xxxxx 1 (kmen Xxxxxxx)⁴ 40 X xxxxxxxx xxxxxxxx

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

typus 3 (xxxx Saukett)⁴ 32 X jednotek xxxxxxxx

Xxxxxxxxxxx xxxxxxxxxx xxxxx x xxxxxxxxxxxxxxx

(Xxxxxxxxxxxxxxxxxxx phosphas) 10 mikrogramů

conj. xxx xxxxxx. xxxxxxxx jako xxxxx xxxxxxx přibližně 25 mikrogramů

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

² vyrobeno xxxxxxxxxxxxx DNA xxxxxxxxxxx xx xxxxxxx xxxxxxxxxxxx xxxxx Saccharomyces cerevisiae)

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

⁴ xxxxxxxxx xx VERO xxxxxxx

XXXX

1xx) xxxxxxxxxxx xxxxxxxx xxxxx xxxxx záškrtu, xxxxxxxx xxxxx (xxxxxxxxxx xxxxx), xxxxxx, dětské přenosné xxxxx (xxxxxxxxxxxx xxxxx), xxxxxx xxxxxxxxxx X, xxxxxxx vyvolaným Xxxxxxxxxxx xxxxxxxxxx xxx x (XXxXXxxXXXXXX)

Xxxxx xxxxx¹ (0,5 xx) obsahuje:

Diphtheriae xxxxxxxxxx xx xxxx než 20 mezinárodních xxxxxxxx (XX)²

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

Xxxxxxxx Xxxxxxxxxx pertussis

Pertussis anatoxinum 25 mikrogramů

Haemagglutinum xxxxxxxxxxxx 25 xxxxxxxxxx

Xxxxx Xxxxxxxxxxxxxxx (xxxxxxxxxxxx)³

xxxxx 1 (Xxxxxxx) 40 D xxxxxxxx xxxxxxxx⁴

xxxxx 2 (XXX-1) 8 X xxxxxxxx xxxxxxxx⁴

xxxxx 3 (Xxxxxxx) 32 X jednotek xxxxxxxx⁴

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx X⁵ 10 xxxxxxxxxx

Xxxxxxxxxxxxxxxxxxx xxxxxxxx xxxxxxxxxx xxxxxxxxxx X 12 xxxxxxxxxx

(Xxxxxxxxxxxxxxxxxxx xxxxxxxx)

xxxxxxxxx xxx xxxxxx xxxxxxxxxx 22-36 xxxxxxxxxx

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

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

³ xxxxxxxxx xx XXXX xxxxxxx

⁴ nebo xxxxxxxxxxxx xxxxxxxx xxxxxxxx stanovené xxxxxxx xxxxxxxxxxxxxx metodou

⁵ xxxxxxxx rekombinantní XXX xxxxxxxxxxx x kvasinkových xxxxxxx Hansenula xxxxxxxxxx

XXXX

1xx) Xxxxxxx proti xxxxxxx, xxxxxx, dávivému xxxxx (xxxxxxxxxx komponenta), xxxxxxxxxx X (xXXX), dětské xxxxxxxx obrně (xxxxxxxxxxxx) x konjugovaná vakcína xxxxx Xxxxxxxxxxx xxxx x (adsorbovaná)

Jedna dávka (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx xxxxxxxxxx¹ ne xxxx xxx 20 XX

Xxxxxx xxxxxxxxxx¹ ne xxxx xxx 40 XX

Xxxxxxxx Xxxxxxxxxxx xxxxxxxx¹

Xxxxxxxxx xxxxxxxxxx (XX) 20 xxxxxxxxxx

Xxxxxxxxxxxxxxx xxxxxxxxxxxx (FHA) 20 xxxxxxxxxx

Xxxxxxxxxxx (XXX) 3 xxxxxxxxxx

Xxxxxxxx xxxx 2 xx 3 (XXX) 5 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx B^2,3 10 xxxxxxxxxx

Xxxxx poliomyelitidis (xxxxxxxxxxx)⁴

Xxxxx 1 (Xxxxxxx) 40 X xxxxxxxx xxxxxxxx⁵

Xxxxx 2 (MEF-1) 8 X xxxxxxxx antigenu⁵

Typus 3 (Xxxxxxx) 32 X xxxxxxxx xxxxxxxx⁵

Xxxxxxxxxxxxxx Xxxxxxxxxx xxxxxxxxxx typus x

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

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

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

³ xxxxxxxx xxxxxxxxxxxxx XXX xxxxxxxxxxx v xxxxxxxxxxxx xxxxxxx Saccharomyces xxxxxxxxxx

⁴ pomnoženo na Xxxx xxxxxxx

⁵ xxxx xxxxxxxxxxxx xxxxxxxx antigenu xxxxxxxxx xxxxxxx imunochemickou xxxxxxx.

1x) očkovací xxxxx xxxxx xxxxxxx, dávivému xxxxx (xxxxxxxxxx forma), xxxxxx (XXxX)

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

Diphtheriae xxxxxxxxxx* ≥ 30 XX

Xxxxxx xxxxxxxxxx* ≥ 40 IU

Pertussis xxxxxxxxxx* (XX) 25 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxxx filamentosum* (XXX) 25 xxxxxxxxxx

Xxxxxxxxxxx* (69 xX) 8 mikrogramů

* xxxxxxxxxxx na xxxxxxxx xxxxxxx celkem: 0,5 xxxxxxxxx

XXXX

1xx) Očkovací xxxxx xxxxx záškrtu, xxxxxx x xxxxxxxx kašli (xxxxxxxxxx) xx sníženým xxxxxxx xxxxxxxx (Xxxx)

Xxxxx xxxxx (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx xxxxxxxxxx - Xxxxxxxxx 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, xxxx 2 xx 3 - 5 xxxxxxxxxx

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

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

XXXX

1xx) Xxxxxxxx xxxxx proti xxxxxxx, xxxxxx a xxxxxxxx xxxxx (acelulární xxxxxxxxxx) xx sníženým obsahem xxxxxxxx (Xxxx)

Xxxxx xxxxx (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx xxxxxxxxxx¹ ne méně xxx 2 mezinárodní xxxxxxxx (XX) (2,5 Xx)

Xxxxxx xxxxxxxxxx¹ ne xxxx xxx 20 xxxxxxxxxxxxx xxxxxxxx (XX) (5 Xx)

Xxxxxxxxxxx xxxxxxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxxx¹ 8 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxx xxxxxxxxxxxx¹ 8 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxx xxxxxxxx xxxxxxxxx¹ 2,5 xxxxxxxxxx

¹ adsorbováno na xxxxxxxxxxx xxxxxxxx xxxxxxx (Xx(XX)₃) 0,3 xxxxxxxxx Xx³⁺ a xxxxxxxxxxx xxxxxxx (XxXX₄) 0,2 xxxxxxxxx Xx³⁺

1x) xxxxxxxx xxxxx xxxxx nákazám xxxxxxxxx Haemophilus xxxxxxxxxx xxx x:

Xxxxx xxxxx xxxxxxxxxxxxx vakcíny xxxxxxxx:

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

1x) xxxxxxxx látka xxxxx xxxxxx:

Xxxxx xxxxx xxxxxxxx:

Xxxxxx xxxxxxxxxx - xxx. 40 mezinárodních xxxxxxxx

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

Xxxxx dávka xxxxxxxx:

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx X - 10 xxxxxxxxxx

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

Xxxxx xxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx B - 20 xxxxxxxxxx

1x) xxxxxxxx xxxxx proti spalničkám, xxxxxxxxxx x zarděnkám:

Jedna xxxxx xxxxxxxx:

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

Parotitidis xxxxx xxxxxxxxxx¹ (XXX 4385) xxx. 10^3,0 xxxxxxxx xxxxx xxx xxxxxxxx xxxxxxx₅₀³

Xxxxxxxx virus xxxxxxxxxx² (Wistar XX 27/3) min. 10^3,0 xxxxxxxx dávka xxx xxxxxxxx xxxxxxx₅₀³

¹ xxxxxxxxx xx buňkách kuřecích xxxxxx

² xxxxxxxxx xx xxxxxxxx diploidních xxxxxxx (XXX-5)

³ 50% xxxxxxxx xxxxx tkáňové xxxxxxx

XXXX

1xx) xxxxxxxx xxxxx xxxxx xxxxxxxxxx, xxxxxxxxxx x xxxxxxxxx

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

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

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

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

* 50 % xxxxxxxx xxxxx buněčné xxxxxxx

¹ xxxxxxxx xx xxxxxxx xxxxxxxx xxxxxx.

² xxxxxxxx na xxxxxxxx xxxxxxxxxxx xxxxxxxx XX-38 xxxxxxxxxxxxx.

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

Xxxxx dávka obsahuje:

Virus xxxxxxxxxxxxx xxxxxxxxxxx typus 1 (Mahoney).....40 xxxxxxxxxxx X xxxxxxxx*

Xxxxx poliomyelitis xxxxxxxxxxx xxxxx 2 (XXX-1) ..........8 xxxxxxxxxxx X xxxxxxxx*

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

* xxxx xxxxxxxx xxxxxxxxxxxxxx antigenů xxxxxxxxx xxxxxx xxxxxx imunochemické xxxxxx.

1xx) xxxxxxxx xxxxx xxxxx pneumokokovým xxxxxxxx xxxxxxxxx x sekvenčním xxxxxxxx:

1xxx) xxxxxxxxxxx xxxxxxxx xxxxx obsahuje:

Streptococci pneumoniae xxxxxxxxxxxxxxx sérotypus 1¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 3¹ 2,2 µg

Streptococci 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 µx

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx sérotypus 7X¹ 2,2 µg

Streptococci xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 9X¹ 2,2 µg

Streptococci xxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 14¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 18X¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 19X¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 19X¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 23F¹ 2,2 µx

¹ Xxxxxxxxxx x nosným xxxxxxxxx XXX197 x adsorbován xx fosforečnan xxxxxxx (0,125 mg xxxxxxx).

1xxx) xxxxxxxxxxxxxxx xxxxxxxx látka xxxxxxxx:

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

1x) xxxxxxxx látka xxxxx xxxxxxx, xxxxxxxx xxxxx (acelulární xxxxx), xxxxxx, xxxxxx přenosné xxxxx (xxxxxxxxxxxx xxxxx):

Xxxxx xxxxx (0,5 ml) xxxxxxxx:

Xxxxxxxxxxx anatoxinum¹ - xx xxxx než 2 mezinárodní xxxxxxxx (XX) (2,5 Lf)

Tetani xxxxxxxxxx¹ - xx xxxx xxx 20 xxxxxxxxxxxxx jednotek (IU) (5 Xx)

Xxxxxxxxxxx xxxxxxxxx xxxxxxxx:

Xxxxxxxxx anatoxinum¹ - 8 xxxxxxxxxx

Xxxxxxxxx haemagglutinum xxxxxxxxxxxx¹ - 8 xxxxxxxxxx

Xxxxxxxxx1 2,5 xxxxxxxxxx

Xxxxx xxxxxxxxxxxxxxx inactivatum:

typus 1 (xxxx Xxxxxxx)² - 40 D xxxxxxxx xxxxxxxx

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

xxxxx 3 (kmen Saukett)² - 32 X xxxxxxxx antigenu

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

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 xx) xxxxxxxx:

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

Xxxxxx anatoxinum xxxxxxxxx 20 XX* (5 Xx)

Xxxxxxxxx antigeny:

Pertussis anatoxinum 2,5 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxxxx xxxxxxxxxxxx 5 xxxxxxxxxx

Xxxxxxxxxxx 3 xxxxxxxxxx

Xxxxxxxx, xxxx 2 xx 3 5 mikrogramů

Virus poliomyelitidis (xxxxxxxxxxx)**

xxxxx 1 40 X jednotek xxxxxxxx

xxxxx 2 8 D xxxxxxxx xxxxxxxx

xxxxx 3 32 X xxxxxxxx xxxxxxxx

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

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

** Xxxxxxxxxxx na Xxxx xxxxxxx.

1x) očkovací xxxxx proti xxxxxxxxxxx (XXX vakcína)

1k) xxxxxxxx xxxxx xxxxx virové xxxxxxxxxx X pro xxxxx zařazené xx xxxxxxxxxxxx xxxxxxxx:

Xxxxx dávka (0,5 ml) xxxxxxx xxxxxxxx:

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

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

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

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

2. Antigenní xxxxxxx xxxxxxxxxx látek xxx xxxxxxxx xxxxxxxx

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

Xxxxx xxxxx obsahuje:

Antigenum xxxxxxxxx xxxxxxxxxxx X - 20 mikrogramů

2b) xxxxxxxx látka proti xxxxxxxxx

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

Xxxxx dávka xxxxxxxx:

Xxxxxxxxx X xxxxx xxxxxxxxxxx

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

Xxxxx dávka xxxxxxxx:

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

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

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

¹ xxxxxxxxx xx xxxxxxx kuřecích xxxxxx

² xxxxxxxxx xx xxxxxxxx xxxxxxxxxxx xxxxxxx (MRC-5)

³ 50% xxxxxxxx xxxxx xxxxxxx kultury

NEBO

2da) xxxxxxxx xxxxx xxxxx spalničkám, xxxxxxxxxx x zarděnkám

Po xxxxxxxxxx obsahuje jedna xxxxx (0,5 ml):

Virus xxxxxxxxxxx¹ vivum xxxxxxxxxx (xxxx Xxxxxx’ Xxxxxxxxx) xx xxxx xxx 1x10³ CCID₅₀*

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

Xxxxx xxxxxxxx² vivum attenuatum (xxxx Wistar XX 27/3) xx méně xxx 1x10³ XXXX₅₀*

* 50 % xxxxxxxx xxxxx buněčné xxxxxxx

¹ xxxxxxxx xx xxxxxxx xxxxxxxx xxxxxx.

² xxxxxxxx xx lidských xxxxxxxxxxx xxxxxxxx WI-38 xxxxxxxxxxxxx.

3. Xxxxxxxxx složení xxxxxxxxxx xxxxx xxx mimořádná xxxxxxxx

3x) očkovací xxxxx xxxxx xxxxxx hepatitidě X xx formuli xxx xxxxxxx:

Xxxxx xxxxxxxxx X inactivatum

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

Xxxxx xxxxxxxxx X xxxxxxxxxxx

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

Xxxxx xxxxx xxxxxxxx:

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

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

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

¹ xxxxxxxxx xx xxxxxxx xxxxxxxx embryí

² xxxxxxxxx xx lidských diploidních xxxxxxx (XXX-5)

³ 50% xxxxxxxx xxxxx tkáňové xxxxxxx

XXXX

3xx) xxxxxxxx xxxxx xxxxx xxxxxxxxxx, příušnicím x xxxxxxxxx

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

Virus morbillorum¹ xxxxx attenuatum (xxxx Xxxxxx’ Edmonston) ne xxxx xxx 1x10³ XXXX₅₀*

Xxxxx xxxxxxxxxxx¹ vivum xxxxxxxxxx (xxxx Xxxxx Xxxx™, xxxxxxx X) xx xxxx než 12,5x10³ CCID₅₀³

Virus rubeolae² xxxxx xxxxxxxxxx (xxxx Xxxxxx XX 27/3) xx xxxx než 1x110³ XXXX₅₀³

* 50% xxxxxxxx xxxxx tkáňové xxxxxxx

¹ xxxxxxxx xx xxxxxxx xxxxxxxx xxxxxx.

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

Xxxxxxx:

xxxx. XXXx. Válek, XXx., XXX, XXXX, x. x.

Xxxxxxxxx

Xxxxxx xxxxxxx č. 41/2023 Sb. xxxxx xxxxxxxxx xxxx 22.2.2023.

Xx xxx xxxxxxxx xxxxxx xxxxxxx xxxxx xxxxx xx xxxxxxxxx.

Xxxxx jednotlivých xxxxxxxx xxxxx xxxxxx xxxxxxxx xxxxxxxx x xxxxxxxx xxxx xxxxxxxxxxxxx, xxxxx xx jich xxxxxx xxxxxxxxx změna xxxxx xxxxxxxxx právního xxxxxxxx.