Plné znění - 249/2018 Sb.

Sdělení o antigenním složení očkovacích látek pro pravidelná, zvláštní a mimořádná očkování pro rok 2019

249/2018 Sb.

Sdělení Ministerstva zdravotnictví

INFORMACE

249

XXXXXXX

Xxxxxxxxxxxx xxxxxxxxxxxxx

xx xxx 25. xxxxx 2018

x xxxxxxxxxx xxxxxxx xxxxxxxxxx xxxxx xxx pravidelná, xxxxxxxx a mimořádná xxxxxxxx xxx rok 2019

 

Xxxxxxxxxxxx xxxxxxxxxxxxx xxxxx §80 odst. 1 xxxx. e) xxxxxx x. 258/2000 Xx., x xxxxxxx xxxxxxxxx xxxxxx x x xxxxx xxxxxxxxx xxxxxxxxxxxxx xxxxxx, xx xxxxx xxxxxxxxxx xxxxxxxx, xxxxxxx xx xxxxxxx xxxxxxxxxx Xxxxxxx xxxxxxxxxx komise xxxxxxxxx xxxxxxx očkovacích xxxxx pro xxxxxxxxxx, xxxxxxxx x xxxxxxxxx xxxxxxxx pro xxx 2019:

1. Xxxxxxxxx xxxxxxx xxxxxxxxxx xxxxx xxx xxxxxxxxxx xxxxxxxx

1x) kombinovaná xxxxxxxx xxxxx proti xxxxxxx, dávivému xxxxx (xxxxxxxxxx xxxxx), tetanu, xxxxxx xxxxxxxx obrně (xxxxxxxxxxxx xxxxx), virové xxxxxxxxxx B, nákazám xxxxxxxxx Xxxxxxxxxxx influenzae xxx x (DTaPHibVHBIPV):

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

Xxxxxxxxxxx xxxxxxxxxx¹ xx xxxx xxx 30 xxxxxxxxxxxxx xxxxxxxx (XX)

Xxxxxx anatoxinum¹ xx xxxx xxx 40 mezinárodních xxxxxxxx (XX)

Xxxxxxxx Xxxxxxxxxx xxxxxxxxx:

Xxxxxxxxx xxxxxxxxxx (XX)¹ 25 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxxxx filamentosum (XXX)¹ 25 mikrogramů

Pertactinum (XXX)¹ 8 xxxxxxxxxx

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

Xxxxx xxxxxxxxxxxxxxx xxxxxxxxxxx (XXX)

xxxxx 1 (xxxx Xxxxxxx)⁴ 40 X jednotek xxxxxxxx

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

typus 3 (xxxx Xxxxxxx)⁴ 32 X jednotek xxxxxxxx

Xxxxxxxxxxx xxxxxxxxxx typus x xxxxxxxxxxxxxxx

(Xxxxxxxxxxxxxxxxxxx xxxxxxxx) 10 xxxxxxxxxx

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

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

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

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

⁴ xxxxxxxxx na XXXX buňkách

NEBO

1aa) xxxxxxxxxxx xxxxxxxx xxxxx xxxxx xxxxxxx, xxxxxxxx kašli (xxxxxxxxxx xxxxx), xxxxxx, xxxxxx xxxxxxxx xxxxx (xxxxxxxxxxxx xxxxx), virové xxxxxxxxxx X, xxxxxxx xxxxxxxxx Haemophilus xxxxxxxxxx xxx x (XXxXXxxXXXXXX)

Xxxxx xxxxx¹ (0,5 xx) xxxxxxxx:

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

Tetani 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 (Mahoney) 40 X jednotek xxxxxxxx⁴

xxxxx 2 (XXX-1) 8 X xxxxxxxx xxxxxxxx⁴

xxxxx 3 (Xxxxxxx) 32 X jednotek xxxxxxxx⁴

Xxxxxxxxx xxxxxxxxx hepatitidis X⁵ 10 xxxxxxxxxx

Xxxxxxxxxxxxxxxxxxx xxxxxxxx xxxxxxxxxx xxxxxxxxxx B 12 mikrogramů

(Polyribosylribitoli xxxxxxxx)

xxxxxxxxx xxx tetani xxxxxxxxxx 22-36 xxxxxxxxxx

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

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

³ xxxxxxxxx xx XXXX xxxxxxx

⁴ nebo xxxxxxxxxxxx xxxxxxxx xxxxxxxx xxxxxxxxx vhodnou xxxxxxxxxxxxxx xxxxxxx

⁵ xxxxxxxx xxxxxxxxxxxxx XXX xxxxxxxxxxx x xxxxxxxxxxxx xxxxxxx Hansenula xxxxxxxxxx

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

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

Xxxxxxxxxxx xxxxxxxxxx* ≥ 30 XX

Xxxxxx anatoxinum* ≥ 40 XX

Xxxxxxxxx xxxxxxxxxx* (XX) 25 mikrogramů

Pertussis xxxxxxxxxxxxxxx xxxxxxxxxxxx* (XXX) 25 xxxxxxxxxx

Xxxxxxxxxxx* (69xX) 8 xxxxxxxxxx

* xxxxxxxxxxx xx xxxxxxxx xxxxxxx xxxxxx: 0,5 miligramů

NEBO

1ba) Xxxxxxxx látka xxxxx xxxxxxx, tetanu x xxxxxxxx xxxxx (xxxxxxxxxx) xx xxxxxxxx xxxxxxx xxxxxxxx

Xxxxx xxxxx (0,5 xx) obsahuje:

Diphtheriae xxxxxxxxxx - Xxxxxxxxx 2 XX* (2 Lf)

Tetani xxxxxxxxxx - Xxxxxxxxx 20 XX* (5 Xx)

Xxxxxxxxx antigeny

Pertussis xxxxxxxxxx - 2,5 xxxxxxxxxx

Xxxxxxxxxxxxxx xxxxxxxxxxxx - 5 xxxxxxxxxx

Xxxxxxxxxxx - 3 xxxxxxxxxx

Xxxxxxxx, typi 2 xx 3 - 5 xxxxxxxxxx

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

* Jako xxxxxx xxxxxxx xxxxxxxxx xxxxxxxxxxxxx (p = 0,95) xxxxxxxx xxxxxx xxxxx xxxxx popsaného x Evropském lékopisu.

NEBO

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

Xxxxx dávka (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx xxxxxxxxxx¹ ne xxxx xxx 2 mezinárodní xxxxxxxx (IU) (2,5 Xx)

Xxxxxx anatoxinum¹ ne xxxx xxx 20 xxxxxxxxxxxxx xxxxxxxx (XX) (5 Xx)

Xxxxxxxxxxx xxxxxxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxxx¹ 8 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxx filamentosum¹ 8 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxx xxxxxxxx proteinum¹ 2,5 xxxxxxxxxx

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

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

Jedna dávka xxxxxxxxxxxxx xxxxxxx xxxxxxxx:

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

1x) xxxxxxxx látka xxxxx xxxxxx:

Xxxxx dávka xxxxxxxx:

Xxxxxx xxxxxxxxxx - xxx. 40 mezinárodních xxxxxxxx

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

Xxxxx xxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxx hepatitidis X - 10 xxxxxxxxxx

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

Xxxxx xxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx B - 20 mikrogramů

1g) xxxxxxxx xxxxx xxxxx xxxxxxxxxx, xxxxxxxxxx a zarděnkám:

Jedna xxxxx obsahuje:

Morbillorum xxxxx xxxxxxxxxx¹ (Schwarz) xxx. 10^3,0 xxxxxxxx dávka xxx xxxxxxxx xxxxxxx³₅₀

Xxxxxxxxxxx xxxxx xxxxxxxxxx¹ (XXX 4385, xxxxxxxx od xxxxx Xxxxx Lynn)) xxx. 10^3,7 xxxxxxxx xxxxx pro xxxxxxxx xxxxxxx³₅₀

Xxxxxxxx virus attenuatum² (Xxxxxx XX 27/3) xxx. 10^3,0 xxxxxxxx xxxxx xxx xxxxxxxx xxxxxxx³₅₀

¹ xxxxxxxxx xx xxxxxxx kuřecích embryí

² xxxxxxxxx na xxxxxxxx xxxxxxxxxxx buňkách (XXX-5)

³ 50% xxxxxxxx xxxxx xxxxxxx kultury

NEBO

1h) xxxxxxxx xxxxx xxxxx xxxxxxxxxx, xxxxxxxxxx x xxxxxxxxx

Xx 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) xx méně xxx 12,5x103 XXXX₅₀*

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

* 50 % xxxxxxxx xxxxx xxxxxxx kultury

¹ xxxxxxxx xx xxxxxxx xxxxxxxx xxxxxx,

² xxxxxxxx xx lidských diploidních xxxxxxxx WI-38 xxxxxxxxxxxxx.

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

Jedna xxxxx xxxxxxxx:

Xxxxx poliomyelitis xxxxxxxxxxx xxxxx 1 (Xxxxxxx)...40 xxxxxxxxxxx D xxxxxxxx*

Xxxxx xxxxxxxxxxxxx inactivatum xxxxx 2 (XXX-1) .......8 antigenních X xxxxxxxx*

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

* xxxx množství xxxxxxxxxxxxxx xxxxxxxx stanovené xxxxxx xxxxxx xxxxxxxxxxxxx xxxxxx.

1x) xxxxxxxx látka konjugovaná xxxxx xxxxxxxxxxxxx xxxxxxxx:

Xxxxx xxxxx xxxxxxxx:

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 1¹ 2,2 µg

Streptococci pneumoniae xxxxxxxxxxxxxxx sérotypus 3¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 4¹ 2,2 µx

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 5¹ 2,2 µg

Streptococci pneumoniae xxxxxxxxxxxxxxx sérotypus 6X¹ 2,2 µx

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 6X¹ 4,4 µx

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 7F¹ 2,2 µg

Streptococci xxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 9X¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 14¹ 2,2 µx

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 18X¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 19A¹ 2,2 µg

Streptococci xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 19X¹ 2,2 µg

Streptococci xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 23X¹ 2,2 µx

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

1x) xxxxxxxx látka xxxxx xxxxxxx, xxxxxxxx xxxxx (xxxxxxxxxx forma), tetanu, xxxxxx přenosné obrně (xxxxxxxxxxxx xxxxx):

Xxxxx xxxxx (0,5 xx) xxxxxxxx:

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

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

Xxxxxxxxxxx xxxxxxxxx xxxxxxxx:

Xxxxxxxxx anatoxinum¹- 8 xxxxxxxxxx

Xxxxxxxxx haemagglutinum xxxxxxxxxxxx¹ - 8 xxxxxxxxxx

Xxxxxxxxx¹ 2,5 mikrogramů

Virus xxxxxxxxxxxxxxx inactivatum:

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

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

typus 3 (kmen Xxxxxxx)² - 32 D xxxxxxxx xxxxxxxx

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

² xxxxxxxxx xx VERO xxxxxxx

1x) očkovací xxxxx xxxxx tuberkulóze (BCG xxxxxxx)

1x) xxxxxxxx xxxxx xxxxx xxxxxx hepatitidě X xxx osoby xxxxxxxx do xxxxxxxxxxxx xxxxxxxx:

Xxxxx dávka (0,5 xx) xxxxxxx obsahuje:

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

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

² xxxxxxxxxxx xx xxxxxxxxxxx xxxxxxx (celkem 0,5 miligramu Xx³⁺)

³ xxxxxxxx xx xxxxxxx xxxxxxxxxxxx xxxxx (Saccharomyces xxxxxxxxxx) rekombinantní XXX xxxxxxxxxxx.

2. Antigenní xxxxxxx xxxxxxxxxx látek xxx xxxxxxxx očkování

2a) očkovací xxxxx xxxxx xxxxxx xxxxxxxxxx X ve xxxxxxx xxx dospělé:

Jedna xxxxx xxxxxxxx:

Xxxxxxxxx tegiminis xxxxxxxxxxx B - 20 mikrogramů

2b) xxxxxxxx xxxxx proti vzteklině

2c) xxxxxxxx xxxxx proti xxxxxx xxxxxxxxxx X xx xxxxxxx xxx xxxxxxx:

Xxxxx dávka xxxxxxxx:

Xxxxxxxxx X xxxxx xxxxxxxxxxx

2x) xxxxxxxx xxxxx xxxxx xxxxxxxxxx, příušnicím a xxxxxxxxx

Xxxxxxxxxxx xxxxx xxxxxxxxxx¹ (Xxxxxxx) min. 10^3,0 xxxxxxxx dávka pro xxxxxxxx xxxxxxx³₅₀

Xxxxxxxxxxx xxxxx xxxxxxxxxx¹ (XXX 4385) xxx. 10^3,7 infekční xxxxx xxx xxxxxxxx xxxxxxx³₅₀

Xxxxxxxx virus xxxxxxxxxx² (Xxxxxx XX 27/3) xxx. 10^3,0 infekční xxxxx pro xxxxxxxx xxxxxxx³₅₀

¹ xxxxxxxxx na xxxxxxx xxxxxxxx embryí

² xxxxxxxxx xx xxxxxxxx xxxxxxxxxxx buňkách (XXX-5)

³ 50% xxxxxxxx dávka xxxxxxx kultur

NEBO

1h) xxxxxxxx xxxxx proti xxxxxxxxxx, xxxxxxxxxx a xxxxxxxxx

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

Xxxxx xxxxxxxxxxx¹ vivum attenuatum (xxxx Enders’ Xxxxxxxxx) xx xxxx xxx 1x103 CCID₅₀*

Virus xxxxxxxxxxx¹ xxxxx attenuatum (kmen Xxxxx Lynn^TM, hladina X) xx xxxx xxx 12,5x103 XXXX₅₀*

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

* 50 % xxxxxxxx xxxxx xxxxxxx kultury

¹ xxxxxxxx xx buňkách xxxxxxxx xxxxxx.

² vyrobeno xx xxxxxxxx xxxxxxxxxxx xxxxxxxx WI-38 xxxxxxxxxxxxx.

3. Xxxxxxxxx xxxxxxx xxxxxxxxxx xxxxx pro xxxxxxxxx xxxxxxxx

3x) xxxxxxxx xxxxx xxxxx virové xxxxxxxxxx X xx xxxxxxx xxx xxxxxxx:

Xxxxxxxxx X xxxxx inactivatum

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

Xxxxx xxxxxxxxx X inactivatum

 

Ministr:

Mgr. xx Xxx. Xxxxxxx, XXX, x. r.

Xxxxxxxxx

Xxxxxx xxxxxxx č. 249/2018 Xx. xxxxx xxxxxxxxx dnem 15.11.2018.

Xx xxx uzávěrky xxxxxx xxxxxxx xxxxx xxxxx xx xxxxxxxxx.

Xxxxx xxxxxxxxxxxx xxxxxxxx xxxxx xxxxxx xxxxxxxx xxxxxxxx x xxxxxxxx není xxxxxxxxxxxxx, xxxxx se jich xxxxxx xxxxxxxxx xxxxx xxxxx xxxxxxxxx xxxxxxxx xxxxxxxx.