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 zdravotnictví

ze xxx 18. xxxxxxxxx 2020

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

 

Xxxxxxxxxxxx xxxxxxxxxxxxx podle §80 xxxx. 1 xxxx. x) xxxxxx x. 258/2000 Sb., x xxxxxxx xxxxxxxxx xxxxxx a o xxxxx xxxxxxxxx souvisejících xxxxxx, xx xxxxx xxxxxxxxxx xxxxxxxx, xxxxxxx xx xxxxxxx doporučení Xxxxxxx xxxxxxxxxx xxxxxx xxxxxxxxx xxxxxxx xxxxxxxxxx xxxxx xxx pravidelná, xxxxxxxx a mimořádná xxxxxxxx pro xxx 2021:

1. Antigenní xxxxxxx xxxxxxxxxx xxxxx xxx xxxxxxxxxx xxxxxxxx

1x) xxxxxxxxxxx xxxxxxxx xxxxx xxxxx xxxxxxx, xxxxxxxx kašli (xxxxxxxxxx forma), xxxxxx, xxxxxx xxxxxxxx xxxxx (xxxxxxxxxxxx xxxxx), virové xxxxxxxxxx B, xxxxxxx xxxxxxxxx Xxxxxxxxxxx xxxxxxxxxx xxx b (XXxXXxxXXXXXX):

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

Diphtheriae xxxxxxxxxx¹ xx méně xxx 30 xxxxxxxxxxxxx xxxxxxxx (XX)

Xxxxxx xxxxxxxxxx¹ xx xxxx xxx 40 xxxxxxxxxxxxx xxxxxxxx (XX)

Xxxxxxxx Xxxxxxxxxx pertussis:

Pertussis xxxxxxxxxx (XX)¹ 25 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxxxx filamentosum (XXX)¹ 25 xxxxxxxxxx

Xxxxxxxxxxx (XXX)¹ 8 mikrogramů

Antigenum xxxxxxxxx xxxxxxxxxxx X (XXx)^2,3 10 mikrogramů

Virus xxxxxxxxxxxxxxx inactivatum (XXX)

xxxxx 1 (xxxx Xxxxxxx)⁴ 40 X xxxxxxxx xxxxxxxx

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

xxxxx 3 (xxxx Saukett)⁴ 32 X xxxxxxxx xxxxxxxx

Xxxxxxxxxxx xxxxxxxxxx xxxxx x xxxxxxxxxxxxxxx

(Xxxxxxxxxxxxxxxxxxx phosphas) 10 xxxxxxxxxx

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

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

² xxxxxxxx rekombinantní XXX xxxxxxxxxxx xx xxxxxxx xxxxxxxxxxxx xxxxx (Xxxxxxxxxxxxx cerevisiae)

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

⁴ xxxxxxxxx na XXXX xxxxxxx

XXXX

1xx) xxxxxxxxxxx xxxxxxxx látka proti xxxxxxx, xxxxxxxx kašli (xxxxxxxxxx xxxxx), xxxxxx, xxxxxx přenosné obrně (xxxxxxxxxxxx xxxxx), xxxxxx xxxxxxxxxx B, xxxxxxx xxxxxxxxx Xxxxxxxxxxx xxxxxxxxxx xxx x (XXxXXxxXXXXXX)

Xxxxx xxxxx¹ (0,5 xx) xxxxxxxx:

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

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

Xxxxxxxx Xxxxxxxxxx xxxxxxxxx

Xxxxxxxxx xxxxxxxxxx 25 xxxxxxxxxx

Xxxxxxxxxxxxxx xxxxxxxxxxxx 25 xxxxxxxxxx

Xxxxx Xxxxxxxxxxxxxxx (inaktivovaný)³

typus 1 (Xxxxxxx) 40 X jednotek xxxxxxxx⁴

xxxxx 2 (MEF-1) 8 X jednotek antigenu⁴

typus 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 mg Xx³⁺)

² xxxx spodní xxx xxxxxxxxxxxxx (p = 0,95)

³ xxxxxxxxx xx VERO xxxxxxx

⁴ xxxx ekvivalentní xxxxxxxx xxxxxxxx xxxxxxxxx xxxxxxx xxxxxxxxxxxxxx xxxxxxx

⁵ vyrobeno xxxxxxxxxxxxx DNA xxxxxxxxxxx x kvasinkových xxxxxxx Xxxxxxxxx xxxxxxxxxx

XXXX

1xx) Vakcína xxxxx xxxxxxxx, tetanu, xxxxxxx (acelulámí komponenta), xxxxxxxxxx X (rDNA), xxxxxxxxxxxxxx (inaktivovaná) x xxxxxxxxxxx xxxxxxx xxxxx Xxxxxxxxxxx typu x (xxxxxxxxxxx)

Xxxxx xxxxx (0,5 xx) obsahuje:

Diphtheriae xxxxxxxxxx¹ xx xxxx xxx 20 IU

Tetani anatoxinum¹ xx xxxx než 40 XX

Xxxxxxxx Xxxxxxxxxxx xxxxxxxx¹

Xxxxxxxxx anatoxinum (PT) 20 mikrogramů

Haemagglutinium filamentosum (XXX) 20 mikrogramů

Pertactinum (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 D xxxxxxxx antigenu⁵

Typus 2 (XXX-1) 8 X xxxxxxxx xxxxxxxx⁵

Xxxxx 3 (Xxxxxxx) 32 X xxxxxxxx antigenu⁵

Polysaccharidi Xxxxxxxxxx xxxxxxxxxx xxxxx x

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

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

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

³ xxxxxxxx xxxxxxxxxxxxx XXX xxxxxxxxxxx x xxxxxxxxxxxx xxxxxxx Xxxxxxxxxxxxx cerevisiae

⁴ xxxxxxxxx na Xxxx xxxxxxx

⁵ nebo ekvivalentní xxxxxxxx antigenu xxxxxxxxx xxxxxxx xxxxxxxxxxxxxx xxxxxxx.

1x) xxxxxxxx látka xxxxx xxxxxxx, xxxxxxxx kašli (xxxxxxxxxx xxxxx), tetanu (XXxX):

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

Xxxxxxxxxxx anatoxinum* ≥ 30 XX

Xxxxxx xxxxxxxxxx* ≥ 40 XX

Xxxxxxxxx xxxxxxxxxx* (XX) 25 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxxxxx* (XXX) 25 xxxxxxxxxx

Xxxxxxxxxxx* (69kD) 8 xxxxxxxxxx

* xxxxxxxxxxx xx xxxxxxxx xxxxxxx xxxxxx: 0,5 miligramů

NEBO

1ba) Očkovací xxxxx xxxxx záškrtu, xxxxxx a xxxxxxxx xxxxx (xxxxxxxxxx) xx xxxxxxxx xxxxxxx antigenů (Xxxx)

Xxxxx dávka (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx xxxxxxxxxx - Xxxxxxxxx 2 XX* (2 Lf)

Tetani 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 xx xxxxxxxxxxx hlinitý - 1,5 xx (0,33 xx xxxxxxx)

* Xxxx xxxxxx xxxxxxx intervalu xxxxxxxxxxxxx (x = 0,95) aktivity měřené xxxxx testu xxxxxxxxx x Evropském lékopisu.

NEBO

1bb) Xxxxxxxx látka xxxxx xxxxxxx, xxxxxx a xxxxxxxx xxxxx (xxxxxxxxxx xxxxxxxxxx) xx xxxxxxxx xxxxxxx xxxxxxxx (Tdap)

Jedna xxxxx (0,5 xx) xxxxxxxx:

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

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

Xxxxxxxxxxx xxxxxxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxxx¹ 8 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxx xxxxxxxxxxxx¹ 8 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxx extemae proteinům¹ 2,5 xxxxxxxxxx

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

1c) xxxxxxxx xxxxx xxxxx xxxxxxx vyvolaným Xxxxxxxxxxx xxxxxxxxxx typ b:

Jedna xxxxx xxxxxxxxxxxxx xxxxxxx xxxxxxxx:

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

1x) očkovací xxxxx proti xxxxxx:

Xxxxx xxxxx xxxxxxxx:

Xxxxxx xxxxxxxxxx - min. 40 xxxxxxxxxxxxx xxxxxxxx

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

Jedna xxxxx xxxxxxxx:

Xxxxxxxxx tegiminis xxxxxxxxxxx X - 10 xxxxxxxxxx

1x) xxxxxxxx látka xxxxx xxxxxx hepatitidě X x dospělé xxxxxxx

Xxxxx xxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx B - 20 xxxxxxxxxx

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

Xxxxx dávka xxxxxxxx:

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

Xxxxxxxxxxx virus xxxxxxxxxx¹ (XXX 4385) min. 10^3,7 xxxxxxxx xxxxx xxx xxxxxxxx kulturu₅₀³

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

¹ xxxxxxxxx xx buňkách xxxxxxxx xxxxxx

² xxxxxxxxx xx xxxxxxxx xxxxxxxxxxx xxxxxxx (MRC-5)

³ 50 % infekční xxxxx xxxxxxx kultury

NEBO

1ga) xxxxxxxx xxxxx xxxxx xxxxxxxxxx, xxxxxxxxxx a zarděnkám

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

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

Xxxxx xxxxxxxxxxx¹ xxxxx attenuatum (xxxx Xxxxx Xxxx^XX, xxxxxxx X) ne méně xxx 12,5x10³ XXXX₅₀*

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

* 50 % xxxxxxxx xxxxx xxxxxxx kultury

¹ xxxxxxxx xx xxxxxxx xxxxxxxx embryí.

² vyrobeno xx xxxxxxxx xxxxxxxxxxx xxxxxxxx XX-38 xxxxxxxxxxxxx.

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

Xxxxx xxxxx xxxxxxxx:

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

Xxxxx xxxxxxxxxxxxx xxxxxxxxxxx xxxxx 2 (XXX-1) ......… 8 xxxxxxxxxxx D xxxxxxxx*

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

* nebo xxxxxxxx xxxxxxxxxxxxxx xxxxxxxx xxxxxxxxx xxxxxx xxxxxx xxxxxxxxxxxxx metody.

1ch) xxxxxxxx xxxxx konjugovaná xxxxx xxxxxxxxxxxxx xxxxxxxx:

Xxxxx dávka xxxxxxxx:

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 1¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum xxxxxxxxx 3¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum xxxxxxxxx 4¹ 2,2 µx

Xxxxxxxxxxxx pneumoniae polysaccharidum xxxxxxxxx 5¹ 2,2 µx

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 6X¹ 2,2 µx

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 6X¹ 4,4 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 7X¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 9V¹ 2,2 µx

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 14¹ 2,2 µx

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 18X¹ 2,2 µx

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 19A¹ 2,2 µx

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 19X¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum xxxxxxxxx 23X¹ 2,2 µx

¹ Xxxxxxxxxx x xxxxxx xxxxxxxxx CRM₁₉₇, xxxxxxxxxx xx xxxxxxxxxxx xxxxxxx.

Xxxxx xxxxx (0,5ml) xxxxxxxx přibližně 32 µx nosného xxxxxxxx XXX₁₉₇ a 0,125 xx xxxxxxx.

1x) očkovací xxxxx xxxxx záškrtu, xxxxxxxx xxxxx (xxxxxxxxxx xxxxx), tetanu, xxxxxx xxxxxxxx xxxxx (inaktivovaná xxxxx):

Xxxxx dávka (0,5 xx) xxxxxxxx:

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

Xxxxxx anatoxinum¹ - xx xxxx než 20 xxxxxxxxxxxxx xxxxxxxx (XX) (5 Xx)

Xxxxxxxxxxx xxxxxxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxxx¹ - 8 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxx filamentosum¹ - 8 xxxxxxxxxx

Xxxxxxxxx¹ 2,5 xxxxxxxxxx

Xxxxx xxxxxxxxxxxxxxx xxxxxxxxxxx:

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

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

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

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

² xxxxxxxxx xx XXXX buňkách

NEBO

1ia) xxxxxxxx xxxxx xxxxx záškrtu, xxxxxxxx xxxxx (acelulární xxxxx), xxxxxx, xxxxxx xxxxxxxx obrně (inaktivovaná xxxxx):

Xxxxx xxxxx (0,5 xx) xxxxxxxx:

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

Xxxxxx xxxxxxxxxx xxxxxxxxx 20 IU* (5 Lf)

Pertusové xxxxxxxx:

Xxxxxxxxx xxxxxxxxxx 2,5 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxxxx xxxxxxxxxxxx 5 xxxxxxxxxx

Xxxxxxxxxxx 3 mikrogramy

Fimbriae, xxxx 2 et 3 5 xxxxxxxxxx

Xxxxx xxxxxxxxxxxxxxx (xxxxxxxxxxx)**

xxxxx 1 40 X xxxxxxxx xxxxxxxx

xxxxx 2 8 X jednotek xxxxxxxx

xxxxx 3 32 X xxxxxxxx xxxxxxxx

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

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

** Kultivováno xx Vero xxxxxxx.

1x) xxxxxxxx xxxxx proti xxxxxxxxxxx (BCG xxxxxxx)

1x) xxxxxxxx látka xxxxx xxxxxx hepatitidě X xxx xxxxx zařazené xx xxxxxxxxxxxx xxxxxxxx:

Xxxxx xxxxx (0,5 xx) xxxxxxx obsahuje:

Antigenum xxxxxxxxx xxxxxxxxxxx X^1,2,3 - 20 xxxxxxxxxx

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

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

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

2. Xxxxxxxxx xxxxxxx xxxxxxxxxx xxxxx xxx xxxxxxxx xxxxxxxx

2x) očkovací xxxxx xxxxx xxxxxx hepatitidě X xx xxxxxxx xxx xxxxxxx:

Xxxxx xxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx X - 20 xxxxxxxxxx

2x) xxxxxxxx xxxxx xxxxx xxxxxxxxx

2x) xxxxxxxx xxxxx proti xxxxxx xxxxxxxxxx A xx xxxxxxx xxx xxxxxxx:

Xxxxx xxxxx xxxxxxxx:

Xxxxxxxxx X xxxxx inactivatum

2d) očkovací xxxxx proti 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 xxxxx xxx xxxxxxxx xxxxxxx₅₀³

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

¹ pomnoženo xx buňkách xxxxxxxx xxxxxx

² xxxxxxxxx na xxxxxxxx xxxxxxxxxxx buňkách (XXX-5)

³ 50 % xxxxxxxx xxxxx tkáňové xxxxxxx

XXXX

2xx) xxxxxxxx xxxxx xxxxx xxxxxxxxxx, xxxxxxxxxx x xxxxxxxxx

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

Xxxxx morbillorum¹ xxxxx attenuatum (xxxx Xxxxxx’ Edmonston) xx xxxx xxx 1x10³ XXXX₅₀*

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

Virus xxxxxxxx² xxxxx attenuatum (kmen Xxxxxx XX 27/3) xx xxxx xxx 1x10³ XXXX₅₀*

* 50 % infekční xxxxx xxxxxxx xxxxxxx

¹ vyrobeno xx xxxxxxx xxxxxxxx xxxxxx

² vyrobeno xx xxxxxxxx xxxxxxxxxxx plicních XX-38 xxxxxxxxxxxxx

3. Xxxxxxxxx xxxxxxx xxxxxxxxxx xxxxx xxx xxxxxxxxx xxxxxxxx

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

Xxxxxxxxx A xxxxx xxxxxxxxxxx

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

Virus xxxxxxxxx X xxxxxxxxxxx

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

Xxxxx xxxxx xxxxxxxx:

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

Xxxxxxxxxxx xxxxx xxxxxxxxxx¹ (XXX 4385) min. 10^3,7 xxxxxxxx xxxxx xxx xxxxxxxx kulturu₅₀³

Rubeolae xxxxx xxxxxxxxxx² (Xxxxxx RA 27/3) xxx. 10^3,0 xxxxxxxx xxxxx pro xxxxxxxx kulturu₅₀³

¹ xxxxxxxxx xx xxxxxxx xxxxxxxx xxxxxx

² xxxxxxxxx xx xxxxxxxx xxxxxxxxxxx xxxxxxx (XXX-5)

³ 50 % xxxxxxxx dávka xxxxxxx xxxxxxx

XXXX

3xx) xxxxxxxx xxxxx xxxxx xxxxxxxxxx, xxxxxxxxxx x xxxxxxxxx

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

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

Xxxxx parotitidis¹ xxxxx xxxxxxxxxx (xxxx Xxxxx Xxxx^XX, xxxxxxx B) xx xxxx xxx 12,5x10³ XXXX₅₀*

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

* 50 % xxxxxxxx xxxxx xxxxxxx xxxxxxx

¹ vyrobeno xx xxxxxxx xxxxxxxx xxxxxx

² vyrobeno na xxxxxxxx xxxxxxxxxxx xxxxxxxx XX-38 xxxxxxxxxxxxx. 

Xxxxxxx:

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

Xxxxxxxxx

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

Ke xxx uzávěrky právní xxxxxxx xxxxx měněn xx xxxxxxxxx.

Xxxxx xxxxxxxxxxxx xxxxxxxx xxxxx xxxxxx xxxxxxxx xxxxxxxx x xxxxxxxx není aktualizováno, xxxxx xx xxxx xxxxxx xxxxxxxxx xxxxx xxxxx uvedeného právního xxxxxxxx.