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 xxxxxxxxxx, xxxxxxxx x xxxxxxxxx xxxxxxxx pro xxx 2019

 

Xxxxxxxxxxxx xxxxxxxxxxxxx podle §80 xxxx. 1 xxxx. x) xxxxxx x. 258/2000 Xx., x xxxxxxx xxxxxxxxx xxxxxx x x xxxxx některých xxxxxxxxxxxxx xxxxxx, ve xxxxx xxxxxxxxxx xxxxxxxx, xxxxxxx xx xxxxxxx xxxxxxxxxx Xxxxxxx xxxxxxxxxx komise xxxxxxxxx xxxxxxx xxxxxxxxxx xxxxx xxx xxxxxxxxxx, xxxxxxxx x mimořádná xxxxxxxx xxx xxx 2019:

1. Xxxxxxxxx složení xxxxxxxxxx látek xxx xxxxxxxxxx xxxxxxxx

1x) xxxxxxxxxxx xxxxxxxx xxxxx proti xxxxxxx, xxxxxxxx kašli (xxxxxxxxxx xxxxx), xxxxxx, xxxxxx přenosné xxxxx (xxxxxxxxxxxx forma), xxxxxx xxxxxxxxxx X, xxxxxxx xxxxxxxxx Xxxxxxxxxxx xxxxxxxxxx xxx x (DTaPHibVHBIPV):

Po xxxxxxxxxxxx 1 dávka (0,5 xx) obsahuje:

Diphtheriae xxxxxxxxxx¹ xx xxxx xxx 30 xxxxxxxxxxxxx xxxxxxxx (XX)

Xxxxxx xxxxxxxxxx¹ xx xxxx xxx 40 xxxxxxxxxxxxx jednotek (XX)

Xxxxxxxx Xxxxxxxxxx xxxxxxxxx:

Xxxxxxxxx xxxxxxxxxx (PT)¹ 25 xxxxxxxxxx

Xxxxxxxxx haemagglutininum xxxxxxxxxxxx (XXX)¹ 25 xxxxxxxxxx

Xxxxxxxxxxx (XXX)¹ 8 xxxxxxxxxx

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

Xxxxx xxxxxxxxxxxxxxx inactivatum (IPV)

typus 1 (kmen Xxxxxxx)⁴ 40 X xxxxxxxx xxxxxxxx

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

xxxxx 3 (xxxx Xxxxxxx)⁴ 32 X xxxxxxxx xxxxxxxx

Xxxxxxxxxxx xxxxxxxxxx typus x xxxxxxxxxxxxxxx

(Xxxxxxxxxxxxxxxxxxx xxxxxxxx) 10 xxxxxxxxxx

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

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

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

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

⁴ xxxxxxxxx xx XXXX xxxxxxx

XXXX

1xx) xxxxxxxxxxx xxxxxxxx xxxxx proti xxxxxxx, xxxxxxxx xxxxx (xxxxxxxxxx forma), tetanu, xxxxxx xxxxxxxx obrně (xxxxxxxxxxxx xxxxx), xxxxxx xxxxxxxxxx B, xxxxxxx xxxxxxxxx Haemophilus influenzae xxx x (XXxXXxxXXXXXX)

Xxxxx xxxxx¹ (0,5 xx) xxxxxxxx:

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

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

Xxxxxxxx Xxxxxxxxxx xxxxxxxxx

Xxxxxxxxx xxxxxxxxxx 25 xxxxxxxxxx

Xxxxxxxxxxxxxx filamentosum 25 xxxxxxxxxx

Xxxxx Xxxxxxxxxxxxxxx (inaktivovaný)³

typus 1 (Xxxxxxx) 40 X jednotek xxxxxxxx⁴

xxxxx 2 (XXX-1) 8 X xxxxxxxx xxxxxxxx⁴

xxxxx 3 (Xxxxxxx) 32 X xxxxxxxx antigenu⁴

Antigenum xxxxxxxxx xxxxxxxxxxx X⁵ 10 xxxxxxxxxx

Xxxxxxxxxxxxxxxxxxx phosphas xxxxxxxxxx xxxxxxxxxx X 12 xxxxxxxxxx

(Xxxxxxxxxxxxxxxxxxx xxxxxxxx)

xxxxxxxxx xxx xxxxxx xxxxxxxxxx 22-36 xxxxxxxxxx

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

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

³ xxxxxxxxx xx XXXX xxxxxxx

⁴ nebo xxxxxxxxxxxx množství xxxxxxxx xxxxxxxxx vhodnou imunochemickou xxxxxxx

⁵ vyrobeno xxxxxxxxxxxxx XXX xxxxxxxxxxx x xxxxxxxxxxxx xxxxxxx Xxxxxxxxx xxxxxxxxxx

1x) očkovací xxxxx xxxxx xxxxxxx, dávivému xxxxx (xxxxxxxxxx forma), xxxxxx (DTaP):

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

Xxxxxxxxxxx xxxxxxxxxx* ≥ 30 XX

Xxxxxx anatoxinum* ≥ 40 XX

Xxxxxxxxx anatoxinum* (XX) 25 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxxxxx* (XXX) 25 xxxxxxxxxx

Xxxxxxxxxxx* (69xX) 8 xxxxxxxxxx

* xxxxxxxxxxx xx hydroxid hlinitý xxxxxx: 0,5 xxxxxxxxx

XXXX

1xx) Xxxxxxxx xxxxx xxxxx xxxxxxx, xxxxxx x xxxxxxxx xxxxx (xxxxxxxxxx) xx xxxxxxxx xxxxxxx xxxxxxxx

Xxxxx xxxxx (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx anatoxinum - Xxxxxxxxx 2 XX* (2 Lf)

Tetani xxxxxxxxxx - Xxxxxxxxx 20 IU* (5 Xx)

Xxxxxxxxx xxxxxxxx

Xxxxxxxxx xxxxxxxxxx - 2,5 xxxxxxxxxx

Xxxxxxxxxxxxxx xxxxxxxxxxxx - 5 xxxxxxxxxx

Xxxxxxxxxxx - 3 xxxxxxxxxx

Xxxxxxxx, xxxx 2 xx 3 - 5 xxxxxxxxxx

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

* Jako xxxxxx xxxxxxx xxxxxxxxx xxxxxxxxxxxxx (p = 0,95) aktivity xxxxxx xxxxx testu xxxxxxxxx x Xxxxxxxxx lékopisu.

NEBO

1bb) Xxxxxxxx látka xxxxx xxxxxxx, tetanu x xxxxxxxx xxxxx (xxxxxxxxxx xxxxxxxxxx) se xxxxxxxx xxxxxxx antigenů

Jedna xxxxx (0,5 xx) obsahuje:

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

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

Xxxxxxxxxxx pertussis xxxxxxxx:

Xxxxxxxxx xxxxxxxxxx¹ 8 xxxxxxxxxx

Xxxxxxxxx haemagglutinum xxxxxxxxxxxx¹ 8 mikrogramů

Pertussis membranae xxxxxxxx xxxxxxxxx¹ 2,5 xxxxxxxxxx

¹ adsorbováno xx xxxxxxxxxxx xxxxxxxx hlinitý (Xx(XX)₃) 0,3 xxxxxxxxx Xx³⁺ x xxxxxxxxxxx xxxxxxx (AlPO₄) 0,2 xxxxxxxxx Xx³⁺

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

Xxxxx xxxxx xxxxxxxxxxxxx vakcíny xxxxxxxx:

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

1x) xxxxxxxx xxxxx xxxxx xxxxxx:

Xxxxx xxxxx xxxxxxxx:

Xxxxxx xxxxxxxxxx - xxx. 40 xxxxxxxxxxxxx xxxxxxxx

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

Xxxxx xxxxx obsahuje:

Antigenum xxxxxxxxx hepatitidis X - 10 xxxxxxxxxx

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

Xxxxx xxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx B - 20 xxxxxxxxxx

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

Xxxxx xxxxx xxxxxxxx:

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

Xxxxxxxxxxx xxxxx attenuatum¹ (XXX 4385, xxxxxxxx xx xxxxx Xxxxx Xxxx)) xxx. 10^3,7 infekční xxxxx xxx xxxxxxxx xxxxxxx³₅₀

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

¹ pomnoženo na xxxxxxx xxxxxxxx embryí

² xxxxxxxxx xx lidských xxxxxxxxxxx buňkách (XXX-5)

³ 50% xxxxxxxx xxxxx xxxxxxx xxxxxxx

XXXX

1x) xxxxxxxx xxxxx xxxxx xxxxxxxxxx, xxxxxxxxxx a xxxxxxxxx

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

Xxxxx xxxxxxxxxxx¹ xxxxx attenuatum (xxxx Xxxxxx’ Xxxxxxxxx) xx xxxx xxx 1x103 CCID₅₀*

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

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

* 50 % xxxxxxxx xxxxx xxxxxxx xxxxxxx

¹ xxxxxxxx xx xxxxxxx xxxxxxxx xxxxxx,

² xxxxxxxx xx xxxxxxxx xxxxxxxxxxx xxxxxxxx XX-38 xxxxxxxxxxxxx.

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

Xxxxx xxxxx xxxxxxxx:

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

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

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

* xxxx xxxxxxxx xxxxxxxxxxxxxx xxxxxxxx stanovené xxxxxx xxxxxx xxxxxxxxxxxxx xxxxxx.

1x) xxxxxxxx látka konjugovaná xxxxx pneumokokovým xxxxxxxx:

Xxxxx xxxxx xxxxxxxx:

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 1¹ 2,2 µg

Streptococci xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 3¹ 2,2 µg

Streptococci xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 4¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 5¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 6A¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 6X¹ 4,4 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 7X¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 9X¹ 2,2 µx

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx sérotypus 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 23F¹ 2,2 µx

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

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

Xxxxx xxxxx (0,5 ml) xxxxxxxx:

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

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

Xxxxxxxxxxx xxxxxxxxx xxxxxxxx:

Xxxxxxxxx anatoxinum¹- 8 mikrogramů

Pertussis haemagglutinum xxxxxxxxxxxx¹ - 8 xxxxxxxxxx

Xxxxxxxxx¹ 2,5 xxxxxxxxxx

Xxxxx xxxxxxxxxxxxxxx inactivatum:

typus 1 (xxxx Mahoney)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 xxxxxxxxxxx xxxxxxxx xxxxxxx (Xx(XX)₃) 0,3 xxxxxxxxx Xx³⁺ x xxxxxxxxxxx xxxxxxx (XxXX₄) 0,2 xxxxxxxxx Xx³⁺

² xxxxxxxxx xx XXXX xxxxxxx

1x) očkovací látka xxxxx xxxxxxxxxxx (BCG xxxxxxx)

1x) očkovací látka xxxxx xxxxxx xxxxxxxxxx X xxx xxxxx xxxxxxxx xx dialyzačního xxxxxxxx:

Xxxxx xxxxx (0,5 xx) vakcíny xxxxxxxx:

Xxxxxxxxx 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 adsorbovaný xx xxxxxxxxxxx xxxxxxx (xxxxxx 0,5 miligramu Al³⁺)

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

2. Xxxxxxxxx složení xxxxxxxxxx látek xxx xxxxxxxx xxxxxxxx

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

Jedna xxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx X - 20 xxxxxxxxxx

2x) očkovací xxxxx proti xxxxxxxxx

2x) xxxxxxxx látka proti xxxxxx hepatitidě A xx xxxxxxx xxx xxxxxxx:

Xxxxx dávka obsahuje:

Hepatitis X xxxxx inactivatum

2d) xxxxxxxx xxxxx proti xxxxxxxxxx, xxxxxxxxxx a xxxxxxxxx

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

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

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

¹ xxxxxxxxx xx xxxxxxx xxxxxxxx xxxxxx

² xxxxxxxxx xx xxxxxxxx xxxxxxxxxxx xxxxxxx (XXX-5)

³ 50% infekční xxxxx xxxxxxx xxxxxx

XXXX

1x) xxxxxxxx xxxxx proti 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 xxxxxxxxxx (xxxx Xxxxx Xxxx^XX, hladina X) ne méně xxx 12,5x103 CCID₅₀*

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

* 50 % xxxxxxxx xxxxx xxxxxxx kultury

¹ xxxxxxxx xx buňkách xxxxxxxx xxxxxx.

² xxxxxxxx xx xxxxxxxx xxxxxxxxxxx xxxxxxxx XX-38 xxxxxxxxxxxxx.

3. Xxxxxxxxx xxxxxxx xxxxxxxxxx xxxxx pro mimořádná xxxxxxxx

3x) očkovací xxxxx xxxxx xxxxxx hepatitidě X xx xxxxxxx xxx xxxxxxx:

Xxxxxxxxx X xxxxx xxxxxxxxxxx

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

Xxxxx xxxxxxxxx X xxxxxxxxxxx

 

Xxxxxxx:

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

Xxxxxxxxx

Xxxxxx předpis č. 249/2018 Sb. xxxxx xxxxxxxxx xxxx 15.11.2018.

Xx xxx xxxxxxxx xxxxxx xxxxxxx xxxxx xxxxx xx xxxxxxxxx.

Xxxxx xxxxxxxxxxxx xxxxxxxx xxxxx jiných xxxxxxxx xxxxxxxx x xxxxxxxx xxxx aktualizováno, xxxxx se jich xxxxxx xxxxxxxxx xxxxx xxxxx uvedeného xxxxxxxx xxxxxxxx.