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 zdravotnictví

ze xxx 25. xxxxx 2018

x xxxxxxxxxx xxxxxxx xxxxxxxxxx xxxxx xxx pravidelná, xxxxxxxx x xxxxxxxxx xxxxxxxx xxx xxx 2019

 

Xxxxxxxxxxxx xxxxxxxxxxxxx podle §80 xxxx. 1 xxxx. x) zákona x. 258/2000 Xx., x xxxxxxx xxxxxxxxx xxxxxx x x xxxxx některých xxxxxxxxxxxxx xxxxxx, ve xxxxx xxxxxxxxxx předpisů, stanoví xx základě xxxxxxxxxx Xxxxxxx xxxxxxxxxx xxxxxx xxxxxxxxx složení očkovacích xxxxx xxx xxxxxxxxxx, xxxxxxxx x xxxxxxxxx xxxxxxxx xxx xxx 2019:

1. Xxxxxxxxx xxxxxxx xxxxxxxxxx xxxxx xxx xxxxxxxxxx xxxxxxxx

1x) kombinovaná xxxxxxxx látka proti xxxxxxx, xxxxxxxx kašli (xxxxxxxxxx xxxxx), tetanu, xxxxxx xxxxxxxx xxxxx (xxxxxxxxxxxx xxxxx), xxxxxx xxxxxxxxxx X, xxxxxxx xxxxxxxxx Haemophilus xxxxxxxxxx xxx b (DTaPHibVHBIPV):

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

Diphtheriae xxxxxxxxxx¹ xx méně xxx 30 mezinárodních xxxxxxxx (XX)

Xxxxxx xxxxxxxxxx¹ xx xxxx než 40 xxxxxxxxxxxxx xxxxxxxx (XX)

Xxxxxxxx Bordetelly xxxxxxxxx:

Xxxxxxxxx xxxxxxxxxx (XX)¹ 25 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxxxx xxxxxxxxxxxx (XXX)¹ 25 mikrogramů

Pertactinum (XXX)¹ 8 mikrogramů

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

Xxxxx xxxxxxxxxxxxxxx xxxxxxxxxxx (IPV)

typus 1 (xxxx Xxxxxxx)⁴ 40 D xxxxxxxx xxxxxxxx

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

xxxxx 3 (xxxx Xxxxxxx)⁴ 32 X xxxxxxxx xxxxxxxx

Xxxxxxxxxxx xxxxxxxxxx typus b xxxxxxxxxxxxxxx

(Xxxxxxxxxxxxxxxxxxx xxxxxxxx) 10 xxxxxxxxxx

xxxx. cum xxxxxx. xxxxxxxx xxxx xxxxx xxxxxxx přibližně 25 xxxxxxxxxx

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

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

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

⁴ pomnoženo na XXXX buňkách

NEBO

1aa) xxxxxxxxxxx xxxxxxxx xxxxx xxxxx xxxxxxx, xxxxxxxx xxxxx (xxxxxxxxxx xxxxx), xxxxxx, xxxxxx přenosné obrně (xxxxxxxxxxxx xxxxx), xxxxxx xxxxxxxxxx B, nákazám xxxxxxxxx Xxxxxxxxxxx influenzae xxx b (DTaPHibVHBIPV)

Jedna xxxxx¹ (0,5 ml) xxxxxxxx:

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

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

Xxxxxxxx Xxxxxxxxxx xxxxxxxxx

Xxxxxxxxx anatoxinum 25 xxxxxxxxxx

Xxxxxxxxxxxxxx xxxxxxxxxxxx 25 xxxxxxxxxx

Xxxxx Poliomyelitidis (xxxxxxxxxxxx)³

xxxxx 1 (Mahoney) 40 X jednotek xxxxxxxx⁴

xxxxx 2 (MEF-1) 8 X xxxxxxxx xxxxxxxx⁴

xxxxx 3 (Xxxxxxx) 32 X jednotek antigenu⁴

Antigenum xxxxxxxxx xxxxxxxxxxx X⁵ 10 xxxxxxxxxx

Xxxxxxxxxxxxxxxxxxx xxxxxxxx xxxxxxxxxx xxxxxxxxxx B 12 xxxxxxxxxx

(Xxxxxxxxxxxxxxxxxxx phosphas)

conjugata xxx xxxxxx xxxxxxxxxx 22-36 mikrogramů

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

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

³ xxxxxxxxx xx XXXX buňkách

⁴ nebo xxxxxxxxxxxx množství xxxxxxxx xxxxxxxxx xxxxxxx xxxxxxxxxxxxxx xxxxxxx

⁵ vyrobeno rekombinantní XXX technologií x xxxxxxxxxxxx xxxxxxx Xxxxxxxxx xxxxxxxxxx

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

Xxxxx xxxxx (0,5 xx) obsahuje xxxx xxxxxx látky:

Diphtheriae xxxxxxxxxx* ≥ 30 XX

Xxxxxx xxxxxxxxxx* ≥ 40 IU

Pertussis xxxxxxxxxx* (XX) 25 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxxxxx* (XXX) 25 mikrogramů

Pertactinum* (69kD) 8 xxxxxxxxxx

* xxxxxxxxxxx xx xxxxxxxx xxxxxxx xxxxxx: 0,5 xxxxxxxxx

XXXX

1xx) Xxxxxxxx xxxxx proti xxxxxxx, xxxxxx x xxxxxxxx kašli (acelulární) xx xxxxxxxx obsahem xxxxxxxx

Xxxxx dávka (0,5 xx) obsahuje:

Diphtheriae xxxxxxxxxx - Minimálně 2 XX* (2 Xx)

Xxxxxx xxxxxxxxxx - Minimálně 20 IU* (5 Xx)

Xxxxxxxxx antigeny

Pertussis anatoxinum - 2,5 xxxxxxxxxx

Xxxxxxxxxxxxxx xxxxxxxxxxxx - 5 xxxxxxxxxx

Xxxxxxxxxxx - 3 xxxxxxxxxx

Xxxxxxxx, typi 2 xx 3 - 5 xxxxxxxxxx

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

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

NEBO

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

Xxxxx xxxxx (0,5 xx) obsahuje:

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

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

Bordetellae xxxxxxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxxx¹ 8 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxx xxxxxxxxxxxx¹ 8 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxx xxxxxxxx xxxxxxxxx¹ 2,5 xxxxxxxxxx

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

1x) xxxxxxxx xxxxx xxxxx xxxxxxx xxxxxxxxx Xxxxxxxxxxx influenzae xxx x:

Xxxxx xxxxx xxxxxxxxxxxxx vakcíny obsahuje:

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

1x) očkovací xxxxx xxxxx xxxxxx:

Xxxxx dávka xxxxxxxx:

Xxxxxx xxxxxxxxxx - xxx. 40 mezinárodních xxxxxxxx

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

Xxxxx xxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxx hepatitidis X - 10 xxxxxxxxxx

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

Jedna xxxxx obsahuje:

Antigenum xxxxxxxxx xxxxxxxxxxx X - 20 xxxxxxxxxx

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

Xxxxx xxxxx obsahuje:

Morbillorum xxxxx xxxxxxxxxx¹ (Xxxxxxx) xxx. 10^3,0 xxxxxxxx xxxxx xxx buněčnou xxxxxxx³₅₀

Xxxxxxxxxxx xxxxx xxxxxxxxxx¹ (RIT 4385, odvozený xx xxxxx Xxxxx Lynn)) xxx. 10^3,7 xxxxxxxx xxxxx xxx buněčnou xxxxxxx³₅₀

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

¹ pomnoženo na xxxxxxx xxxxxxxx xxxxxx

² xxxxxxxxx na xxxxxxxx xxxxxxxxxxx buňkách (XXX-5)

³ 50% xxxxxxxx xxxxx xxxxxxx xxxxxxx

XXXX

1x) xxxxxxxx xxxxx xxxxx xxxxxxxxxx, xxxxxxxxxx a zarděnkám

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

Virus xxxxxxxxxxx¹ vivum xxxxxxxxxx (xxxx Xxxxxx’ Xxxxxxxxx) xx méně xxx 1x103 XXXX₅₀*

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

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

* 50 % xxxxxxxx xxxxx xxxxxxx xxxxxxx

¹ xxxxxxxx na xxxxxxx xxxxxxxx xxxxxx,

² vyrobeno xx xxxxxxxx xxxxxxxxxxx xxxxxxxx XX-38 fibroblastech.

1ch) xxxxxxxx xxxxx xxxxx xxxxxx xxxxxxxx obrně x inaktivované formě:

Jedna xxxxx xxxxxxxx:

Xxxxx poliomyelitis xxxxxxxxxxx typus 1 (Xxxxxxx)...40 xxxxxxxxxxx X xxxxxxxx*

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

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

* xxxx xxxxxxxx ekvivalentních xxxxxxxx stanovené xxxxxx xxxxxx xxxxxxxxxxxxx metody.

1i) xxxxxxxx látka xxxxxxxxxxx xxxxx xxxxxxxxxxxxx xxxxxxxx:

Xxxxx xxxxx obsahuje:

Streptococci pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 1¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 3¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 4¹ 2,2 µg

Streptococci xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 5¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 6A¹ 2,2 µg

Streptococci xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 6B¹ 4,4 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 7X¹ 2,2 µg

Streptococci xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 9V¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 14¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 18X¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 19X¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 19X¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 23X¹ 2,2 µx

¹ Xxxxxxxxxx x xxxxxx xxxxxxxxx XXX197 a xxxxxxxxxx xx xxxxxxxxxxx hlinitý (0,125 xx xxxxxxx).

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

Xxxxx dávka (0,5 xx) xxxxxxxx:

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

Xxxxxx xxxxxxxxxx¹ xx méně xxx 20 mezinárodních xxxxxxxx (XX) (5 Xx)

Xxxxxxxxxxx xxxxxxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxxx¹- 8 mikrogramů

Pertussis haemagglutinum xxxxxxxxxxxx¹ - 8 xxxxxxxxxx

Xxxxxxxxx¹ 2,5 mikrogramů

Virus xxxxxxxxxxxxxxx xxxxxxxxxxx:

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

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

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

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

² xxxxxxxxx xx XXXX xxxxxxx

1x) xxxxxxxx xxxxx xxxxx xxxxxxxxxxx (XXX xxxxxxx)

1x) xxxxxxxx xxxxx xxxxx virové xxxxxxxxxx X pro xxxxx xxxxxxxx xx dialyzačního xxxxxxxx:

Xxxxx xxxxx (0,5 xx) vakcíny xxxxxxxx:

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

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

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

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

2. Xxxxxxxxx xxxxxxx xxxxxxxxxx látek xxx xxxxxxxx očkování

2a) xxxxxxxx xxxxx proti virové xxxxxxxxxx X xx xxxxxxx xxx xxxxxxx:

Xxxxx xxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx B - 20 mikrogramů

2b) xxxxxxxx xxxxx xxxxx xxxxxxxxx

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

Xxxxx xxxxx xxxxxxxx:

Xxxxxxxxx X virus xxxxxxxxxxx

2x) xxxxxxxx xxxxx xxxxx xxxxxxxxxx, xxxxxxxxxx a xxxxxxxxx

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

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

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

¹ pomnoženo na xxxxxxx xxxxxxxx embryí

² xxxxxxxxx xx lidských xxxxxxxxxxx buňkách (XXX-5)

³ 50% infekční xxxxx xxxxxxx xxxxxx

XXXX

1x) očkovací xxxxx xxxxx spalničkám, xxxxxxxxxx x zarděnkám

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

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

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

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

* 50 % xxxxxxxx xxxxx xxxxxxx xxxxxxx

¹ xxxxxxxx na xxxxxxx xxxxxxxx xxxxxx.

² xxxxxxxx xx xxxxxxxx xxxxxxxxxxx xxxxxxxx WI-38 fibroblastech.

3. Xxxxxxxxx xxxxxxx xxxxxxxxxx xxxxx xxx xxxxxxxxx xxxxxxxx

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

Xxxxxxxxx X xxxxx xxxxxxxxxxx

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

Xxxxx xxxxxxxxx X inactivatum

 

Ministr:

Mgr. xx Xxx. Vojtěch, XXX, x. x.

Xxxxxxxxx

Xxxxxx xxxxxxx x. 249/2018 Sb. xxxxx xxxxxxxxx xxxx 15.11.2018.

Ke xxx uzávěrky xxxxxx xxxxxxx xxxxx měněn xx xxxxxxxxx.

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