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

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Xxxxxxxxxxxx xxxxxxxxxxxxx

xx dne 18. xxxxxxxxx 2020

o xxxxxxxxxx xxxxxxx xxxxxxxxxx xxxxx xxx xxxxxxxxxx, xxxxxxxx a xxxxxxxxx xxxxxxxx pro rok 2021

 

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

1. Xxxxxxxxx složení xxxxxxxxxx xxxxx xxx xxxxxxxxxx xxxxxxxx

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

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

Xxxxxxxxxxx xxxxxxxxxx¹ xx xxxx xxx 30 xxxxxxxxxxxxx xxxxxxxx (XX)

Xxxxxx xxxxxxxxxx¹ xx xxxx než 40 mezinárodních jednotek (XX)

Xxxxxxxx Xxxxxxxxxx xxxxxxxxx:

Xxxxxxxxx xxxxxxxxxx (XX)¹ 25 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxxxx xxxxxxxxxxxx (XXX)¹ 25 xxxxxxxxxx

Xxxxxxxxxxx (XXX)¹ 8 mikrogramů

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

Virus xxxxxxxxxxxxxxx xxxxxxxxxxx (XXX)

xxxxx 1 (xxxx Mahoney)⁴ 40 X xxxxxxxx xxxxxxxx

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

xxxxx 3 (xxxx Saukett)⁴ 32 X xxxxxxxx xxxxxxxx

Xxxxxxxxxxx xxxxxxxxxx xxxxx b xxxxxxxxxxxxxxx

(Xxxxxxxxxxxxxxxxxxx phosphas) 10 xxxxxxxxxx

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

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

² xxxxxxxx xxxxxxxxxxxxx XXX technologií xx xxxxxxx xxxxxxxxxxxx buněk (Xxxxxxxxxxxxx cerevisiae)

³ xxxxxxxxxxx xx fosforečnan hlinitý (XxXX₄) 0,32 miligramů Xx³⁺

⁴ pomnoženo xx XXXX xxxxxxx

XXXX

1xx) xxxxxxxxxxx xxxxxxxx xxxxx proti xxxxxxx, dávivému kašli (xxxxxxxxxx xxxxx), xxxxxx, xxxxxx xxxxxxxx xxxxx (xxxxxxxxxxxx xxxxx), virové xxxxxxxxxx X, xxxxxxx xxxxxxxxx Xxxxxxxxxxx xxxxxxxxxx xxx b (XXxXXxxXXXXXX)

Xxxxx xxxxx¹ (0,5 ml) xxxxxxxx:

Xxxxxxxxxxx anatoxinum xx xxxx xxx 20 xxxxxxxxxxxxx xxxxxxxx (XX)²

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

Xxxxxxxx Xxxxxxxxxx xxxxxxxxx

Xxxxxxxxx xxxxxxxxxx 25 xxxxxxxxxx

Xxxxxxxxxxxxxx xxxxxxxxxxxx 25 xxxxxxxxxx

Xxxxx Xxxxxxxxxxxxxxx (xxxxxxxxxxxx)³

xxxxx 1 (Xxxxxxx) 40 X xxxxxxxx xxxxxxxx⁴

xxxxx 2 (MEF-1) 8 X jednotek xxxxxxxx⁴

xxxxx 3 (Xxxxxxx) 32 X xxxxxxxx xxxxxxxx⁴

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx X⁵ 10 xxxxxxxxxx

Xxxxxxxxxxxxxxxxxxx phosphas xxxxxxxxxx xxxxxxxxxx X 12 xxxxxxxxxx

(Xxxxxxxxxxxxxxxxxxx xxxxxxxx)

xxxxxxxxx xxx xxxxxx xxxxxxxxxx 22-36 xxxxxxxxxx

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

² xxxx spodní xxx spolehlivosti (x = 0,95)

³ xxxxxxxxx xx XXXX buňkách

⁴ xxxx ekvivalentní xxxxxxxx xxxxxxxx stanovené xxxxxxx xxxxxxxxxxxxxx xxxxxxx

⁵ vyrobeno xxxxxxxxxxxxx XXX technologií x xxxxxxxxxxxx xxxxxxx Xxxxxxxxx xxxxxxxxxx

XXXX

1xx) Xxxxxxx xxxxx xxxxxxxx, xxxxxx, xxxxxxx (xxxxxxxxx komponenta), xxxxxxxxxx B (xXXX), xxxxxxxxxxxxxx (xxxxxxxxxxxx) x xxxxxxxxxxx xxxxxxx xxxxx Xxxxxxxxxxx typu x (xxxxxxxxxxx)

Xxxxx xxxxx (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx xxxxxxxxxx¹ xx xxxx než 20 XX

Xxxxxx xxxxxxxxxx¹ xx méně xxx 40 IU

Antigena Bordetellae xxxxxxxx¹

Xxxxxxxxx xxxxxxxxxx (XX) 20 mikrogramů

Haemagglutinium filamentosum (XXX) 20 xxxxxxxxxx

Xxxxxxxxxxx (XXX) 3 xxxxxxxxxx

Xxxxxxxx xxxx 2 xx 3 (FIM) 5 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx X^2,3 10 xxxxxxxxxx

Xxxxx xxxxxxxxxxxxxxx (inactivatum)⁴

Typus 1 (Xxxxxxx) 40 D xxxxxxxx antigenu⁵

Typus 2 (XXX-1) 8 X xxxxxxxx antigenu⁵

Typus 3 (Xxxxxxx) 32 X xxxxxxxx xxxxxxxx⁵

Xxxxxxxxxxxxxx Haemophili xxxxxxxxxx xxxxx b

(Polyribosylribitoli xxxxxxxx) 3 xxxxxxxxxx xxxxxxxxxx cum proteinům xxxxxxxxxxxx typus b² 50 xxxxxxxxxx

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

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

³ xxxxxxxx xxxxxxxxxxxxx XXX xxxxxxxxxxx x xxxxxxxxxxxx xxxxxxx Xxxxxxxxxxxxx xxxxxxxxxx

⁴ xxxxxxxxx xx Xxxx xxxxxxx

⁵ xxxx xxxxxxxxxxxx xxxxxxxx xxxxxxxx stanovené xxxxxxx imunochemickou xxxxxxx.

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

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

Xxxxxxxxxxx xxxxxxxxxx* ≥ 30 XX

Xxxxxx xxxxxxxxxx* ≥ 40 XX

Xxxxxxxxx xxxxxxxxxx* (XX) 25 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxxxxx* (XXX) 25 xxxxxxxxxx

Xxxxxxxxxxx* (69kD) 8 xxxxxxxxxx

* xxxxxxxxxxx na xxxxxxxx xxxxxxx xxxxxx: 0,5 miligramů

NEBO

1ba) Očkovací xxxxx xxxxx xxxxxxx, xxxxxx x dávivému xxxxx (xxxxxxxxxx) xx xxxxxxxx obsahem xxxxxxxx (Xxxx)

Xxxxx xxxxx (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx anatoxinum - Xxxxxxxxx 2 XX* (2 Lf)

Tetani xxxxxxxxxx - Minimálně 20 XX* (5 Xx)

Xxxxxxxxx xxxxxxxx

Xxxxxxxxx anatoxinum - 2,5 xxxxxxxxxx

Xxxxxxxxxxxxxx xxxxxxxxxxxx - 5 xxxxxxxxxx

Xxxxxxxxxxx - 3 xxxxxxxxxx

Xxxxxxxx, xxxx 2 xx 3 - 5 mikrogramů

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

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

XXXX

1xx) Xxxxxxxx xxxxx xxxxx xxxxxxx, xxxxxx x xxxxxxxx xxxxx (acelulární xxxxxxxxxx) xx sníženým xxxxxxx antigenů (Tdap)

Jedna xxxxx (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx xxxxxxxxxx¹ ne xxxx xxx 2 xxxxxxxxxxx jednotky (IU) (2,5 Xx)

Xxxxxx xxxxxxxxxx¹ xx xxxx než 20 xxxxxxxxxxxxx xxxxxxxx (XX) (5 Xx)

Xxxxxxxxxxx xxxxxxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxxx¹ 8 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxx xxxxxxxxxxxx¹ 8 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxx xxxxxxx xxxxxxxxx¹ 2,5 xxxxxxxxxx

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

1c) xxxxxxxx látka xxxxx xxxxxxx vyvolaným Xxxxxxxxxxx xxxxxxxxxx xxx x:

Xxxxx xxxxx xxxxxxxxxxxxx vakcíny xxxxxxxx:

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

1x) očkovací xxxxx proti xxxxxx:

Xxxxx xxxxx xxxxxxxx:

Xxxxxx anatoxinum - min. 40 xxxxxxxxxxxxx jednotek

1e) xxxxxxxx xxxxx xxxxx xxxxxx xxxxxxxxxx B v xxxxxx formuli:

Jedna dávka xxxxxxxx:

Xxxxxxxxx xxxxxxxxx hepatitidis X - 10 xxxxxxxxxx

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

Xxxxx dávka xxxxxxxx:

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx X - 20 mikrogramů

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

Xxxxx xxxxx obsahuje:

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

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

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

¹ xxxxxxxxx xx xxxxxxx xxxxxxxx xxxxxx

² xxxxxxxxx xx xxxxxxxx xxxxxxxxxxx xxxxxxx (XXX-5)

³ 50 % infekční xxxxx xxxxxxx xxxxxxx

XXXX

1xx) očkovací xxxxx proti xxxxxxxxxx, xxxxxxxxxx x zarděnkám

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

Xxxxx xxxxxxxxxxx¹ vivum attenuatum (xxxx Xxxxxx’ Xxxxxxxxx) xx xxxx než 1x10³ XXXX₅₀*

Xxxxx parotitidis¹ xxxxx xxxxxxxxxx (xxxx Xxxxx Xxxx^XX, xxxxxxx X) xx xxxx xxx 12,5x10³ CCID₅₀*

Virus xxxxxxxx² vivum xxxxxxxxxx (xxxx Xxxxxx XX 27/3) ne méně xxx 1x10³ XXXX₅₀*

* 50 % xxxxxxxx xxxxx xxxxxxx xxxxxxx

¹ xxxxxxxx xx xxxxxxx xxxxxxxx xxxxxx.

² xxxxxxxx xx xxxxxxxx xxxxxxxxxxx xxxxxxxx XX-38 xxxxxxxxxxxxx.

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

Jedna xxxxx obsahuje:

Virus xxxxxxxxxxxxx xxxxxxxxxxx xxxxx 1 (Xxxxxxx) … 40 xxxxxxxxxxx D xxxxxxxx*

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

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

* xxxx xxxxxxxx xxxxxxxxxxxxxx antigenů xxxxxxxxx xxxxxx vhodné xxxxxxxxxxxxx xxxxxx.

1xx) xxxxxxxx xxxxx xxxxxxxxxxx xxxxx xxxxxxxxxxxxx infekcím:

Jedna xxxxx xxxxxxxx:

Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum xxxxxxxxx 1¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 3¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum xxxxxxxxx 4¹ 2,2 µx

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 5¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 6X¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum xxxxxxxxx 6B¹ 4,4 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 7X¹ 2,2 µx

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 9X¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 14¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 18X¹ 2,2 µx

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 19X¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 19X¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 23X¹ 2,2 µx

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

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

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

Xxxxx xxxxx (0,5 xx) obsahuje:

Diphtheriae anatoxinum¹ - xx xxxx xxx 2 mezinárodní xxxxxxxx (XX) (2,5 Xx)

Xxxxxx xxxxxxxxxx¹ - xx méně xxx 20 xxxxxxxxxxxxx xxxxxxxx (XX) (5 Lf)

Bordetellae xxxxxxxxx xxxxxxxx:

Xxxxxxxxx anatoxinum¹ - 8 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxx xxxxxxxxxxxx¹ - 8 xxxxxxxxxx

Xxxxxxxxx¹ 2,5 xxxxxxxxxx

Xxxxx xxxxxxxxxxxxxxx xxxxxxxxxxx:

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

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

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

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

² xxxxxxxxx xx XXXX buňkách

NEBO

1ia) xxxxxxxx xxxxx xxxxx xxxxxxx, xxxxxxxx kašli (acelulární xxxxx), xxxxxx, dětské xxxxxxxx xxxxx (xxxxxxxxxxxx xxxxx):

Xxxxx xxxxx (0,5 xx) xxxxxxxx:

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

Tetani anatoxinum xxxxxxxxx 20 XX* (5 Xx)

Xxxxxxxxx antigeny:

Pertussis xxxxxxxxxx 2,5 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxxxx xxxxxxxxxxxx 5 xxxxxxxxxx

Xxxxxxxxxxx 3 xxxxxxxxxx

Xxxxxxxx, xxxx 2 xx 3 5 xxxxxxxxxx

Xxxxx xxxxxxxxxxxxxxx (inactivatum)**

typus 1 40 X xxxxxxxx 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 xxxxxxxxx xxxxxxxxxxxxx (x = 0,95) xxxxxxxx měřené podle xxxxx xxxxxxxxx v Xxxxxxxxx xxxxxxxx.

** Xxxxxxxxxxx xx Vero xxxxxxx.

1x) xxxxxxxx xxxxx xxxxx xxxxxxxxxxx (BCG xxxxxxx)

1x) xxxxxxxx xxxxx xxxxx xxxxxx hepatitidě B xxx osoby xxxxxxxx xx dialyzačního xxxxxxxx:

Xxxxx xxxxx (0,5 xx) xxxxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx B^1,2,3 - 20 xxxxxxxxxx

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

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

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

2. Xxxxxxxxx xxxxxxx xxxxxxxxxx xxxxx xxx xxxxxxxx xxxxxxxx

2x) xxxxxxxx látka xxxxx virové hepatitidě X ve xxxxxxx xxx xxxxxxx:

Xxxxx dávka xxxxxxxx:

Xxxxxxxxx tegiminis xxxxxxxxxxx X - 20 xxxxxxxxxx

2x) očkovací xxxxx xxxxx xxxxxxxxx

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

Jedna xxxxx xxxxxxxx:

Xxxxxxxxx A xxxxx inactivatum

2d) xxxxxxxx xxxxx xxxxx xxxxxxxxxx, xxxxxxxxxx x zarděnkám:

Jedna xxxxx obsahuje:

Morbillorum xxxxx xxxxxxxxxx¹ (Xxxxxxx) min. 10^3,0 infekční xxxxx xxx buněčnou xxxxxxx₅₀³

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

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

¹ pomnoženo xx buňkách kuřecích xxxxxx

² xxxxxxxxx xx xxxxxxxx diploidních xxxxxxx (XXX-5)

³ 50 % xxxxxxxx dávka tkáňové xxxxxxx

XXXX

2xx) xxxxxxxx xxxxx xxxxx xxxxxxxxxx, xxxxxxxxxx x zarděnkám

Po rozpuštění xxxxxxxx xxxxx xxxxx (0,5 ml):

Virus morbillorum¹ xxxxx xxxxxxxxxx (kmen Xxxxxx’ Xxxxxxxxx) xx xxxx xxx 1x10³ XXXX₅₀*

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

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

* 50 % xxxxxxxx xxxxx xxxxxxx kultury

¹ xxxxxxxx xx buňkách xxxxxxxx xxxxxx

² vyrobeno na xxxxxxxx xxxxxxxxxxx plicních XX-38 xxxxxxxxxxxxx

3. Xxxxxxxxx xxxxxxx očkovacích látek xxx xxxxxxxxx xxxxxxxx

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

Xxxxxxxxx X xxxxx xxxxxxxxxxx

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

Xxxxx hepatitis X xxxxxxxxxxx

3x) očkovací xxxxx xxxxx spalničkám, xxxxxxxxxx x xxxxxxxxx:

Xxxxx xxxxx obsahuje:

Morbillorum virus xxxxxxxxxx¹ (Schwarz) min. 10^3,0 infekční dávka xxx buněčnou kulturu₅₀³

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

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

¹ xxxxxxxxx xx xxxxxxx xxxxxxxx xxxxxx

² xxxxxxxxx na xxxxxxxx xxxxxxxxxxx xxxxxxx (XXX-5)

³ 50 % xxxxxxxx xxxxx xxxxxxx xxxxxxx

XXXX

3xx) xxxxxxxx látka xxxxx xxxxxxxxxx, příušnicím x xxxxxxxxx

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

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

Xxxxx parotitidis¹ xxxxx xxxxxxxxxx (xxxx Xxxxx Xxxx^XX, hladina X) xx méně xxx 12,5x10³ XXXX₅₀*

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

* 50 % infekční xxxxx xxxxxxx xxxxxxx

¹ vyrobeno xx buňkách xxxxxxxx xxxxxx

² xxxxxxxx na xxxxxxxx xxxxxxxxxxx plicních XX-38 fibroblastech. 

Ministr:

doc. MUDr. Xxxxxx, Xx.X., v. x.

Xxxxxxxxx

Xxxxxx předpis č. 509/2020 Xx. nabyl xxxxxxxxx dnem 7.12.2020.

Xx xxx xxxxxxxx xxxxxx xxxxxxx nebyl xxxxx xx xxxxxxxxx.

Xxxxx xxxxxxxxxxxx xxxxxxxx norem xxxxxx xxxxxxxx xxxxxxxx x xxxxxxxx není aktualizováno, xxxxx xx jich xxxxxx derogační xxxxx xxxxx uvedeného právního xxxxxxxx.