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 rok 2021

 

Xxxxxxxxxxxx xxxxxxxxxxxxx xxxxx §80 odst. 1 xxxx. x) xxxxxx x. 258/2000 Sb., x xxxxxxx xxxxxxxxx xxxxxx x x xxxxx xxxxxxxxx xxxxxxxxxxxxx xxxxxx, ve xxxxx xxxxxxxxxx xxxxxxxx, xxxxxxx xx xxxxxxx xxxxxxxxxx Xxxxxxx xxxxxxxxxx xxxxxx xxxxxxxxx složení xxxxxxxxxx xxxxx pro xxxxxxxxxx, xxxxxxxx a xxxxxxxxx xxxxxxxx xxx xxx 2021:

1. Antigenní složení xxxxxxxxxx látek xxx xxxxxxxxxx xxxxxxxx

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

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

Xxxxxxxxxxx xxxxxxxxxx¹ xx méně xxx 30 xxxxxxxxxxxxx xxxxxxxx (XX)

Xxxxxx anatoxinum¹ xx méně xxx 40 mezinárodních xxxxxxxx (XX)

Xxxxxxxx Xxxxxxxxxx pertussis:

Pertussis xxxxxxxxxx (PT)¹ 25 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxxxx filamentosum (XXX)¹ 25 mikrogramů

Pertactinum (XXX)¹ 8 xxxxxxxxxx

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

Xxxxx xxxxxxxxxxxxxxx xxxxxxxxxxx (IPV)

typus 1 (xxxx Xxxxxxx)⁴ 40 X xxxxxxxx xxxxxxxx

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

xxxxx 3 (xxxx Xxxxxxx)⁴ 32 X xxxxxxxx antigenu

Haemophilus xxxxxxxxxx xxxxx x xxxxxxxxxxxxxxx

(Xxxxxxxxxxxxxxxxxxx phosphas) 10 xxxxxxxxxx

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

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

² xxxxxxxx xxxxxxxxxxxxx XXX xxxxxxxxxxx na xxxxxxx xxxxxxxxxxxx xxxxx (Xxxxxxxxxxxxx cerevisiae)

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

⁴ pomnoženo xx XXXX xxxxxxx

XXXX

1xx) kombinovaná xxxxxxxx látka proti xxxxxxx, xxxxxxxx xxxxx (xxxxxxxxxx forma), xxxxxx, xxxxxx xxxxxxxx obrně (xxxxxxxxxxxx xxxxx), virové xxxxxxxxxx B, xxxxxxx xxxxxxxxx Haemophilus xxxxxxxxxx xxx x (DTaPHibVHBIPV)

Jedna xxxxx¹ (0,5 ml) xxxxxxxx:

Xxxxxxxxxxx xxxxxxxxxx ne xxxx než 20 xxxxxxxxxxxxx xxxxxxxx (IU)²

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

Antigeny Xxxxxxxxxx xxxxxxxxx

Xxxxxxxxx xxxxxxxxxx 25 xxxxxxxxxx

Xxxxxxxxxxxxxx xxxxxxxxxxxx 25 xxxxxxxxxx

Xxxxx Xxxxxxxxxxxxxxx (inaktivovaný)³

typus 1 (Mahoney) 40 X jednotek xxxxxxxx⁴

xxxxx 2 (MEF-1) 8 X xxxxxxxx antigenu⁴

typus 3 (Xxxxxxx) 32 X xxxxxxxx xxxxxxxx⁴

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx X⁵ 10 xxxxxxxxxx

Xxxxxxxxxxxxxxxxxxx xxxxxxxx xxxxxxxxxx influenzae B 12 mikrogramů

(Polyribosylribitoli phosphas)

conjugata xxx xxxxxx xxxxxxxxxx 22-36 mikrogramů

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

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

³ pomnoženo xx XXXX xxxxxxx

⁴ xxxx ekvivalentní xxxxxxxx xxxxxxxx xxxxxxxxx vhodnou xxxxxxxxxxxxxx xxxxxxx

⁵ xxxxxxxx xxxxxxxxxxxxx XXX xxxxxxxxxxx x xxxxxxxxxxxx xxxxxxx Xxxxxxxxx polymorpha

NEBO

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

Xxxxx xxxxx (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx xxxxxxxxxx¹ xx xxxx xxx 20 IU

Tetani xxxxxxxxxx¹ xx xxxx xxx 40 IU

Antigena Bordetellae xxxxxxxx¹

Xxxxxxxxx xxxxxxxxxx (XX) 20 xxxxxxxxxx

Xxxxxxxxxxxxxxx xxxxxxxxxxxx (XXX) 20 xxxxxxxxxx

Xxxxxxxxxxx (XXX) 3 xxxxxxxxxx

Xxxxxxxx xxxx 2 et 3 (XXX) 5 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx X^2,3 10 xxxxxxxxxx

Xxxxx xxxxxxxxxxxxxxx (xxxxxxxxxxx)⁴

Xxxxx 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 b

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

¹ adsorbováno xx fosforečnan xxxxxxx (0,17 xx Al³⁺)

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

³ xxxxxxxx xxxxxxxxxxxxx XXX xxxxxxxxxxx x xxxxxxxxxxxx xxxxxxx Saccharomyces cerevisiae

⁴ xxxxxxxxx xx Vero xxxxxxx

⁵ xxxx ekvivalentní xxxxxxxx antigenu xxxxxxxxx xxxxxxx imunochemickou xxxxxxx.

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

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

Xxxxxxxxxxx xxxxxxxxxx* ≥ 30 IU

Tetani xxxxxxxxxx* ≥ 40 XX

Xxxxxxxxx xxxxxxxxxx* (PT) 25 mikrogramů

Pertussis haemaglutininum xxxxxxxxxxxx* (XXX) 25 xxxxxxxxxx

Xxxxxxxxxxx* (69xX) 8 xxxxxxxxxx

* adsorbováno na xxxxxxxx xxxxxxx xxxxxx: 0,5 xxxxxxxxx

XXXX

1xx) Xxxxxxxx xxxxx proti xxxxxxx, xxxxxx x xxxxxxxx xxxxx (acelulární) xx xxxxxxxx xxxxxxx antigenů (Xxxx)

Xxxxx xxxxx (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx anatoxinum - Minimálně 2 XX* (2 Xx)

Xxxxxx xxxxxxxxxx - Minimálně 20 IU* (5 Xx)

Xxxxxxxxx xxxxxxxx

Xxxxxxxxx anatoxinum - 2,5 xxxxxxxxxx

Xxxxxxxxxxxxxx xxxxxxxxxxxx - 5 xxxxxxxxxx

Xxxxxxxxxxx - 3 xxxxxxxxxx

Xxxxxxxx, typi 2 xx 3 - 5 mikrogramů

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

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

XXXX

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

Jedna xxxxx (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx anatoxinum¹ xx xxxx xxx 2 xxxxxxxxxxx xxxxxxxx (XX) (2,5 Lf)

Tetani xxxxxxxxxx¹ xx xxxx xxx 20 xxxxxxxxxxxxx xxxxxxxx (XX) (5 Xx)

Xxxxxxxxxxx xxxxxxxxx xxxxxxxx:

Xxxxxxxxx anatoxinum¹ 8 xxxxxxxxxx

Xxxxxxxxx haemagglutinum xxxxxxxxxxxx¹ 8 mikrogramů

Pertussis xxxxxxxxx extemae proteinům¹ 2,5 mikrogramů

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

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

Jedna xxxxx lyofilizované xxxxxxx xxxxxxxx:

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

1x) očkovací xxxxx xxxxx tetanu:

Jedna xxxxx xxxxxxxx:

Xxxxxx anatoxinum - xxx. 40 xxxxxxxxxxxxx xxxxxxxx

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

Xxxxx dávka xxxxxxxx:

Xxxxxxxxx tegiminis xxxxxxxxxxx X - 10 xxxxxxxxxx

1x) xxxxxxxx xxxxx xxxxx virové hepatitidě X x xxxxxxx xxxxxxx

Xxxxx xxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx B - 20 xxxxxxxxxx

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

Xxxxx xxxxx xxxxxxxx:

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

Xxxxxxxxxxx xxxxx attenuatum¹ (XXX 4385) min. 10^3,7 xxxxxxxx xxxxx xxx xxxxxxxx kulturu₅₀³

Rubeolae xxxxx attenuatum² (Xxxxxx XX 27/3) xxx. 10^3,0 infekční xxxxx xxx buněčnou xxxxxxx₅₀³

¹ xxxxxxxxx xx xxxxxxx xxxxxxxx xxxxxx

² xxxxxxxxx xx xxxxxxxx diploidních xxxxxxx (XXX-5)

³ 50 % xxxxxxxx xxxxx xxxxxxx xxxxxxx

XXXX

1xx) xxxxxxxx xxxxx xxxxx xxxxxxxxxx, xxxxxxxxxx x xxxxxxxxx

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

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

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

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

* 50 % xxxxxxxx xxxxx xxxxxxx xxxxxxx

¹ xxxxxxxx na xxxxxxx xxxxxxxx xxxxxx.

² xxxxxxxx xx lidských xxxxxxxxxxx xxxxxxxx XX-38 xxxxxxxxxxxxx.

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

Xxxxx xxxxx xxxxxxxx:

Xxxxx xxxxxxxxxxxxx xxxxxxxxxxx typus 1 (Xxxxxxx) … 40 xxxxxxxxxxx X jednotek*

Virus xxxxxxxxxxxxx xxxxxxxxxxx xxxxx 2 (MEF-1) ......… 8 antigenních X xxxxxxxx*

Xxxxx xxxxxxxxxxxxx xxxxxxxxxxx xxxxx 3 (Saukett) ...… 32 xxxxxxxxxxx X xxxxxxxx*

* nebo xxxxxxxx xxxxxxxxxxxxxx xxxxxxxx xxxxxxxxx xxxxxx vhodné xxxxxxxxxxxxx xxxxxx.

1xx) xxxxxxxx xxxxx xxxxxxxxxxx xxxxx xxxxxxxxxxxxx xxxxxxxx:

Xxxxx xxxxx xxxxxxxx:

Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum xxxxxxxxx 1¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 3¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 4¹ 2,2 µx

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 5¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 6A¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 6B¹ 4,4 µx

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 7F¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum xxxxxxxxx 9X¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 14¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 18X¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 19X¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 19X¹ 2,2 µx

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 23X¹ 2,2 µx

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

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

1x) xxxxxxxx xxxxx xxxxx xxxxxxx, xxxxxxxx xxxxx (xxxxxxxxxx xxxxx), xxxxxx, dětské xxxxxxxx xxxxx (xxxxxxxxxxxx xxxxx):

Xxxxx xxxxx (0,5 xx) obsahuje:

Diphtheriae xxxxxxxxxx¹ - xx xxxx xxx 2 mezinárodní xxxxxxxx (IU) (2,5 Xx)

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

Xxxxxxxxxxx xxxxxxxxx antigena:

Pertussis xxxxxxxxxx¹ - 8 mikrogramů

Pertussis xxxxxxxxxxxxxx filamentosum¹ - 8 xxxxxxxxxx

Xxxxxxxxx¹ 2,5 xxxxxxxxxx

Xxxxx poliomyelitidis xxxxxxxxxxx:

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

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

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

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

² xxxxxxxxx xx XXXX buňkách

NEBO

1ia) xxxxxxxx xxxxx xxxxx xxxxxxx, xxxxxxxx kašli (xxxxxxxxxx xxxxx), xxxxxx, xxxxxx xxxxxxxx obrně (xxxxxxxxxxxx xxxxx):

Xxxxx dávka (0,5 xx) xxxxxxxx:

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

Xxxxxx xxxxxxxxxx xxxxxxxxx 20 XX* (5 Xx)

Xxxxxxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxxx 2,5 mikrogramů

Pertussis xxxxxxxxxxxxxxxx filamentosum 5 xxxxxxxxxx

Xxxxxxxxxxx 3 mikrogramy

Fimbriae, xxxx 2 xx 3 5 xxxxxxxxxx

Xxxxx xxxxxxxxxxxxxxx (inactivatum)**

typus 1 40 D jednotek xxxxxxxx

xxxxx 2 8 X jednotek xxxxxxxx

xxxxx 3 32 X xxxxxxxx antigenu

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

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

** Kultivováno xx Xxxx buňkách.

1j) xxxxxxxx xxxxx proti xxxxxxxxxxx (XXX vakcína)

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

Xxxxx xxxxx (0,5 ml) xxxxxxx obsahuje:

Antigenum xxxxxxxxx xxxxxxxxxxx B^1,2,3 - 20 mikrogramů

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

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

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

2. Xxxxxxxxx xxxxxxx xxxxxxxxxx xxxxx xxx xxxxxxxx xxxxxxxx

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

Xxxxx dávka xxxxxxxx:

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx X - 20 xxxxxxxxxx

2x) xxxxxxxx xxxxx xxxxx xxxxxxxxx

2x) xxxxxxxx xxxxx proti xxxxxx xxxxxxxxxx X xx xxxxxxx pro dospělé:

Jedna xxxxx xxxxxxxx:

Xxxxxxxxx X xxxxx xxxxxxxxxxx

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

Jedna xxxxx xxxxxxxx:

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

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

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

¹ pomnoženo xx buňkách xxxxxxxx xxxxxx

² pomnoženo xx xxxxxxxx xxxxxxxxxxx xxxxxxx (XXX-5)

³ 50 % xxxxxxxx dávka xxxxxxx xxxxxxx

XXXX

2xx) očkovací xxxxx xxxxx spalničkám, xxxxxxxxxx x zarděnkám

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

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

Xxxxx xxxxxxxxxxx¹ vivum xxxxxxxxxx (kmen Xxxxx Xxxx™, xxxxxxx X) xx méně xxx 12,5x10³ XXXX₅₀*

Xxxxx rubeolae² xxxxx xxxxxxxxxx (xxxx Xxxxxx XX 27/3) xx méně xxx 1x10³ CCID₅₀*

* 50 % infekční xxxxx xxxxxxx xxxxxxx

¹ vyrobeno xx xxxxxxx xxxxxxxx xxxxxx

² xxxxxxxx na xxxxxxxx xxxxxxxxxxx plicních XX-38 fibroblastech

3. Xxxxxxxxx xxxxxxx xxxxxxxxxx xxxxx xxx xxxxxxxxx xxxxxxxx

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

Xxxxxxxxx A xxxxx xxxxxxxxxxx

3x) očkovací látka xxxxx virové hepatitidě X xx xxxxxxx xxx děti:

Virus 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 xxxxx xxx xxxxxxxx xxxxxxx₅₀³

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

¹ pomnoženo xx xxxxxxx xxxxxxxx xxxxxx

² pomnoženo na xxxxxxxx diploidních xxxxxxx (XXX-5)

³ 50 % xxxxxxxx xxxxx xxxxxxx xxxxxxx

XXXX

3xx) xxxxxxxx látka xxxxx xxxxxxxxxx, příušnicím x xxxxxxxxx

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

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

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

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

* 50 % infekční dávka xxxxxxx kultury

¹ xxxxxxxx xx xxxxxxx xxxxxxxx xxxxxx

² vyrobeno na xxxxxxxx diploidních xxxxxxxx XX-38 xxxxxxxxxxxxx. 

Xxxxxxx:

xxx. XXXx. Xxxxxx, Ph.D., x. x.

Xxxxxxxxx

Xxxxxx xxxxxxx č. 509/2020 Xx. xxxxx xxxxxxxxx xxxx 7.12.2020.

Xx xxx xxxxxxxx xxxxxx xxxxxxx nebyl xxxxx xx xxxxxxxxx.

Xxxxx jednotlivých xxxxxxxx xxxxx jiných xxxxxxxx xxxxxxxx v xxxxxxxx xxxx xxxxxxxxxxxxx, xxxxx xx xxxx xxxxxx xxxxxxxxx xxxxx xxxxx uvedeného xxxxxxxx xxxxxxxx.