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 složení xxxxxxxxxx xxxxx xxx xxxxxxxxxx, xxxxxxxx x mimořádná xxxxxxxx xxx xxx 2019

 

Xxxxxxxxxxxx zdravotnictví xxxxx §80 xxxx. 1 xxxx. x) xxxxxx x. 258/2000 Xx., x ochraně veřejného xxxxxx a o xxxxx xxxxxxxxx souvisejících xxxxxx, xx xxxxx xxxxxxxxxx předpisů, xxxxxxx xx xxxxxxx xxxxxxxxxx Xxxxxxx xxxxxxxxxx xxxxxx xxxxxxxxx xxxxxxx očkovacích xxxxx xxx xxxxxxxxxx, xxxxxxxx x xxxxxxxxx xxxxxxxx pro xxx 2019:

1. Antigenní složení xxxxxxxxxx látek xxx xxxxxxxxxx očkování

1a) kombinovaná xxxxxxxx xxxxx xxxxx xxxxxxx, xxxxxxxx kašli (xxxxxxxxxx forma), xxxxxx, xxxxxx přenosné xxxxx (xxxxxxxxxxxx xxxxx), virové xxxxxxxxxx B, xxxxxxx xxxxxxxxx Haemophilus xxxxxxxxxx xxx b (DTaPHibVHBIPV):

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

Xxxxxxxxxxx xxxxxxxxxx¹ xx xxxx xxx 30 xxxxxxxxxxxxx xxxxxxxx (XX)

Xxxxxx xxxxxxxxxx¹ xx xxxx než 40 xxxxxxxxxxxxx xxxxxxxx (XX)

Xxxxxxxx Bordetelly pertussis:

Pertussis xxxxxxxxxx (XX)¹ 25 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxxxx filamentosum (XXX)¹ 25 xxxxxxxxxx

Xxxxxxxxxxx (XXX)¹ 8 xxxxxxxxxx

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

Xxxxx xxxxxxxxxxxxxxx xxxxxxxxxxx (XXX)

xxxxx 1 (xxxx Mahoney)⁴ 40 X xxxxxxxx xxxxxxxx

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

xxxxx 3 (xxxx Xxxxxxx)⁴ 32 X xxxxxxxx xxxxxxxx

Xxxxxxxxxxx xxxxxxxxxx typus x xxxxxxxxxxxxxxx

(Xxxxxxxxxxxxxxxxxxx phosphas) 10 xxxxxxxxxx

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

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

² xxxxxxxx rekombinantní XXX xxxxxxxxxxx xx xxxxxxx xxxxxxxxxxxx buněk (Xxxxxxxxxxxxx xxxxxxxxxx)

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

⁴ xxxxxxxxx na XXXX xxxxxxx

XXXX

1xx) xxxxxxxxxxx xxxxxxxx xxxxx proti xxxxxxx, xxxxxxxx xxxxx (xxxxxxxxxx xxxxx), tetanu, xxxxxx přenosné xxxxx (xxxxxxxxxxxx xxxxx), virové xxxxxxxxxx X, xxxxxxx xxxxxxxxx Haemophilus xxxxxxxxxx xxx x (XXxXXxxXXXXXX)

Xxxxx xxxxx¹ (0,5 ml) xxxxxxxx:

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

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

Xxxxxxxx Bordetelly xxxxxxxxx

Xxxxxxxxx xxxxxxxxxx 25 xxxxxxxxxx

Xxxxxxxxxxxxxx xxxxxxxxxxxx 25 xxxxxxxxxx

Xxxxx Poliomyelitidis (xxxxxxxxxxxx)³

xxxxx 1 (Mahoney) 40 X xxxxxxxx antigenu⁴

typus 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 phosphas)

conjugata xxx tetani xxxxxxxxxx 22-36 mikrogramů

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

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

³ xxxxxxxxx xx XXXX xxxxxxx

⁴ xxxx xxxxxxxxxxxx xxxxxxxx antigenu xxxxxxxxx vhodnou imunochemickou xxxxxxx

⁵ xxxxxxxx rekombinantní XXX technologií v xxxxxxxxxxxx xxxxxxx Xxxxxxxxx xxxxxxxxxx

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

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

Diphtheriae xxxxxxxxxx* ≥ 30 XX

Xxxxxx xxxxxxxxxx* ≥ 40 XX

Xxxxxxxxx xxxxxxxxxx* (XX) 25 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxxx filamentosum* (FHA) 25 xxxxxxxxxx

Xxxxxxxxxxx* (69xX) 8 xxxxxxxxxx

* adsorbováno xx xxxxxxxx xxxxxxx xxxxxx: 0,5 xxxxxxxxx

XXXX

1xx) Xxxxxxxx xxxxx xxxxx xxxxxxx, tetanu a xxxxxxxx xxxxx (xxxxxxxxxx) xx xxxxxxxx xxxxxxx xxxxxxxx

Xxxxx xxxxx (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx anatoxinum - Xxxxxxxxx 2 XX* (2 Xx)

Xxxxxx xxxxxxxxxx - Minimálně 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 mg (0,33 xx xxxxxxx)

* Xxxx xxxxxx hranice intervalu xxxxxxxxxxxxx (p = 0,95) xxxxxxxx xxxxxx xxxxx xxxxx popsaného x Xxxxxxxxx lékopisu.

NEBO

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

Xxxxx dávka (0,5 xx) xxxxxxxx:

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

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

Xxxxxxxxxxx xxxxxxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxxx¹ 8 xxxxxxxxxx

Xxxxxxxxx haemagglutinum xxxxxxxxxxxx¹ 8 xxxxxxxxxx

Xxxxxxxxx membranae xxxxxxxx xxxxxxxxx¹ 2,5 xxxxxxxxxx

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

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

Xxxxx xxxxx xxxxxxxxxxxxx xxxxxxx obsahuje:

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

1x) xxxxxxxx xxxxx xxxxx xxxxxx:

Xxxxx dávka xxxxxxxx:

Xxxxxx anatoxinum - xxx. 40 xxxxxxxxxxxxx xxxxxxxx

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

Xxxxx xxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx B - 10 xxxxxxxxxx

1x) xxxxxxxx xxxxx xxxxx xxxxxx hepatitidě B x dospělé formuli

Jedna xxxxx xxxxxxxx:

Xxxxxxxxx tegiminis xxxxxxxxxxx B - 20 mikrogramů

1g) očkovací xxxxx xxxxx xxxxxxxxxx, xxxxxxxxxx a xxxxxxxxx:

Xxxxx xxxxx xxxxxxxx:

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

Xxxxxxxxxxx xxxxx attenuatum¹ (RIT 4385, xxxxxxxx xx xxxxx Xxxxx Xxxx)) xxx. 10^3,7 xxxxxxxx xxxxx pro buněčnou xxxxxxx³₅₀

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

¹ pomnoženo xx xxxxxxx kuřecích xxxxxx

² xxxxxxxxx xx lidských xxxxxxxxxxx xxxxxxx (XXX-5)

³ 50% xxxxxxxx xxxxx xxxxxxx xxxxxxx

XXXX

1x) xxxxxxxx xxxxx proti xxxxxxxxxx, xxxxxxxxxx a zarděnkám

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

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

Xxxxx xxxxxxxxxxx¹ xxxxx xxxxxxxxxx (kmen Xxxxx Xxxx^XX, xxxxxxx X) ne xxxx xxx 12,5x103 CCID₅₀*

Virus xxxxxxxx² xxxxx xxxxxxxxxx (xxxx Wistar RA 27/3) ne xxxx xxx 1x103 XXXX₅₀*

* 50 % xxxxxxxx xxxxx xxxxxxx xxxxxxx

¹ xxxxxxxx xx xxxxxxx xxxxxxxx xxxxxx,

² xxxxxxxx xx xxxxxxxx xxxxxxxxxxx xxxxxxxx WI-38 xxxxxxxxxxxxx.

1xx) xxxxxxxx xxxxx xxxxx xxxxxx xxxxxxxx xxxxx x inaktivované xxxxx:

Xxxxx xxxxx xxxxxxxx:

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

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

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

* xxxx xxxxxxxx xxxxxxxxxxxxxx xxxxxxxx stanovené pomocí xxxxxx xxxxxxxxxxxxx metody.

1i) xxxxxxxx látka xxxxxxxxxxx xxxxx xxxxxxxxxxxxx infekcím:

Jedna xxxxx xxxxxxxx:

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 1¹ 2,2 µx

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx sérotypus 3¹ 2,2 µg

Streptococci xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 4¹ 2,2 µx

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx sérotypus 5¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 6A¹ 2,2 µg

Streptococci xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 6B¹ 4,4 µx

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx sérotypus 7X¹ 2,2 µg

Streptococci xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 9X¹ 2,2 µg

Streptococci xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 14¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 18X¹ 2,2 µx

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 19X¹ 2,2 µx

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx sérotypus 19X¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 23F¹ 2,2 µx

¹ Xxxxxxxxxx x xxxxxx xxxxxxxxx XXX197 x adsorbován xx xxxxxxxxxxx hlinitý (0,125 mg hliníku).

1j) xxxxxxxx xxxxx proti xxxxxxx, xxxxxxxx xxxxx (xxxxxxxxxx xxxxx), tetanu, xxxxxx xxxxxxxx xxxxx (xxxxxxxxxxxx xxxxx):

Xxxxx xxxxx (0,5 xx) xxxxxxxx:

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

Xxxxxx xxxxxxxxxx¹ xx xxxx xxx 20 mezinárodních jednotek (XX) (5 Lf)

Bordetellae xxxxxxxxx antigena:

Pertussis xxxxxxxxxx¹- 8 xxxxxxxxxx

Xxxxxxxxx haemagglutinum xxxxxxxxxxxx¹ - 8 xxxxxxxxxx

Xxxxxxxxx¹ 2,5 mikrogramů

Virus xxxxxxxxxxxxxxx xxxxxxxxxxx:

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

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

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

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

² xxxxxxxxx na VERO xxxxxxx

1x) očkovací xxxxx xxxxx tuberkulóze (BCG xxxxxxx)

1x) xxxxxxxx xxxxx xxxxx xxxxxx xxxxxxxxxx X xxx xxxxx xxxxxxxx xx xxxxxxxxxxxx xxxxxxxx:

Xxxxx dávka (0,5 xx) xxxxxxx xxxxxxxx:

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

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

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

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

2. Antigenní xxxxxxx xxxxxxxxxx xxxxx xxx xxxxxxxx očkování

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

Xxxxx xxxxx obsahuje:

Antigenum xxxxxxxxx xxxxxxxxxxx B - 20 xxxxxxxxxx

2x) xxxxxxxx xxxxx xxxxx xxxxxxxxx

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

Xxxxx xxxxx xxxxxxxx:

Xxxxxxxxx X virus inactivatum

2d) xxxxxxxx látka proti xxxxxxxxxx, xxxxxxxxxx a xxxxxxxxx

Xxxxxxxxxxx virus attenuatum¹ (Xxxxxxx) xxx. 10^3,0 xxxxxxxx xxxxx pro xxxxxxxx xxxxxxx³₅₀

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

Xxxxxxxx xxxxx xxxxxxxxxx² (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 (MRC-5)

³ 50% xxxxxxxx xxxxx xxxxxxx xxxxxx

XXXX

1x) očkovací xxxxx xxxxx xxxxxxxxxx, xxxxxxxxxx a xxxxxxxxx

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

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

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

Xxxxx xxxxxxxx² xxxxx attenuatum (xxxx Wistar XX 27/3) xx xxxx xxx 1x103 CCID₅₀*

* 50 % infekční xxxxx buněčné xxxxxxx

¹ xxxxxxxx xx xxxxxxx xxxxxxxx embryí.

² vyrobeno xx xxxxxxxx xxxxxxxxxxx xxxxxxxx WI-38 xxxxxxxxxxxxx.

3. Xxxxxxxxx složení očkovacích xxxxx pro mimořádná xxxxxxxx

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

Xxxxxxxxx X xxxxx inactivatum

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

Xxxxx xxxxxxxxx A xxxxxxxxxxx

 

Xxxxxxx:

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

Xxxxxxxxx

Xxxxxx předpis x. 249/2018 Xx. xxxxx xxxxxxxxx xxxx 15.11.2018.

Xx xxx xxxxxxxx xxxxxx xxxxxxx xxxxx měněn xx xxxxxxxxx.

Xxxxx xxxxxxxxxxxx xxxxxxxx xxxxx jiných xxxxxxxx xxxxxxxx v xxxxxxxx není aktualizováno, xxxxx se xxxx xxxxxx xxxxxxxxx xxxxx xxxxx uvedeného právního xxxxxxxx.