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 xxxxxxxxxx, xxxxxxxx a xxxxxxxxx xxxxxxxx xxx xxx 2019

 

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

1. Xxxxxxxxx xxxxxxx xxxxxxxxxx xxxxx pro xxxxxxxxxx xxxxxxxx

1x) xxxxxxxxxxx xxxxxxxx xxxxx xxxxx xxxxxxx, xxxxxxxx xxxxx (xxxxxxxxxx forma), tetanu, xxxxxx přenosné xxxxx (xxxxxxxxxxxx xxxxx), xxxxxx xxxxxxxxxx B, nákazám xxxxxxxxx Xxxxxxxxxxx influenzae xxx x (DTaPHibVHBIPV):

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

Xxxxxxxxxxx xxxxxxxxxx¹ xx méně xxx 30 xxxxxxxxxxxxx xxxxxxxx (IU)

Tetani xxxxxxxxxx¹ xx méně xxx 40 xxxxxxxxxxxxx jednotek (XX)

Xxxxxxxx Xxxxxxxxxx xxxxxxxxx:

Xxxxxxxxx xxxxxxxxxx (XX)¹ 25 xxxxxxxxxx

Xxxxxxxxx haemagglutininum xxxxxxxxxxxx (XXX)¹ 25 mikrogramů

Pertactinum (XXX)¹ 8 mikrogramů

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

Xxxxx xxxxxxxxxxxxxxx xxxxxxxxxxx (IPV)

typus 1 (xxxx Mahoney)⁴ 40 X xxxxxxxx xxxxxxxx

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

typus 3 (xxxx Saukett)⁴ 32 X jednotek antigenu

Haemophilus xxxxxxxxxx xxxxx b xxxxxxxxxxxxxxx

(Xxxxxxxxxxxxxxxxxxx phosphas) 10 xxxxxxxxxx

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

¹ adsorbováno na xxxxxxxx hlinitý, xxxxxxxxxxx (Xx(XX)₃) 0,5 miligramů Xx³⁺

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

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

⁴ xxxxxxxxx xx XXXX buňkách

NEBO

1aa) xxxxxxxxxxx xxxxxxxx látka proti xxxxxxx, dávivému xxxxx (xxxxxxxxxx xxxxx), tetanu, xxxxxx xxxxxxxx xxxxx (xxxxxxxxxxxx xxxxx), xxxxxx xxxxxxxxxx B, nákazám xxxxxxxxx Xxxxxxxxxxx xxxxxxxxxx xxx x (XXxXXxxXXXXXX)

Xxxxx xxxxx¹ (0,5 xx) xxxxxxxx:

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

Tetani xxxxxxxxxx xx xxxx xxx 40 mezinárodních xxxxxxxx (XX)²

Xxxxxxxx Bordetelly xxxxxxxxx

Xxxxxxxxx xxxxxxxxxx 25 xxxxxxxxxx

Xxxxxxxxxxxxxx xxxxxxxxxxxx 25 xxxxxxxxxx

Xxxxx Xxxxxxxxxxxxxxx (xxxxxxxxxxxx)³

xxxxx 1 (Xxxxxxx) 40 X xxxxxxxx xxxxxxxx⁴

xxxxx 2 (XXX-1) 8 X xxxxxxxx antigenu⁴

typus 3 (Saukett) 32 X xxxxxxxx xxxxxxxx⁴

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx B⁵ 10 xxxxxxxxxx

Xxxxxxxxxxxxxxxxxxx xxxxxxxx xxxxxxxxxx xxxxxxxxxx X 12 xxxxxxxxxx

(Xxxxxxxxxxxxxxxxxxx phosphas)

conjugata xxx tetani xxxxxxxxxx 22-36 mikrogramů

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

² xxxx spodní xxx xxxxxxxxxxxxx (p= 0,95)

³ xxxxxxxxx xx XXXX xxxxxxx

⁴ nebo xxxxxxxxxxxx množství xxxxxxxx xxxxxxxxx xxxxxxx xxxxxxxxxxxxxx xxxxxxx

⁵ xxxxxxxx xxxxxxxxxxxxx XXX xxxxxxxxxxx x xxxxxxxxxxxx xxxxxxx Hansenula xxxxxxxxxx

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

Jedna xxxxx (0,5 ml) obsahuje xxxx léčivé látky:

Diphtheriae xxxxxxxxxx* ≥ 30 XX

Xxxxxx xxxxxxxxxx* ≥ 40 IU

Pertussis xxxxxxxxxx* (XX) 25 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxxxxx* (XXX) 25 mikrogramů

Pertactinum* (69xX) 8 mikrogramů

* adsorbováno xx hydroxid hlinitý xxxxxx: 0,5 xxxxxxxxx

XXXX

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

Xxxxx dávka (0,5 xx) obsahuje:

Diphtheriae xxxxxxxxxx - Xxxxxxxxx 2 XX* (2 Xx)

Xxxxxx xxxxxxxxxx - Xxxxxxxxx 20 IU* (5 Xx)

Xxxxxxxxx antigeny

Pertussis xxxxxxxxxx - 2,5 xxxxxxxxxx

Xxxxxxxxxxxxxx xxxxxxxxxxxx - 5 xxxxxxxxxx

Xxxxxxxxxxx - 3 xxxxxxxxxx

Xxxxxxxx, typi 2 xx 3 - 5 mikrogramů

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

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

XXXX

1xx) Xxxxxxxx látka proti xxxxxxx, xxxxxx x xxxxxxxx kašli (xxxxxxxxxx xxxxxxxxxx) xx xxxxxxxx xxxxxxx xxxxxxxx

Xxxxx dávka (0,5 xx) xxxxxxxx:

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

Xxxxxx xxxxxxxxxx¹ ne xxxx xxx 20 xxxxxxxxxxxxx jednotek (XX) (5 Xx)

Xxxxxxxxxxx xxxxxxxxx xxxxxxxx:

Xxxxxxxxx anatoxinum¹ 8 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxx xxxxxxxxxxxx¹ 8 mikrogramů

Pertussis xxxxxxxxx xxxxxxxx xxxxxxxxx¹ 2,5 xxxxxxxxxx

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

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

Jedna xxxxx xxxxxxxxxxxxx xxxxxxx obsahuje:

Polysaccharidum Xxx xxxxxxxxxxx (10 xxxxxxxxxx) xxx Anatoxino 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 dávka obsahuje:

Antigenum xxxxxxxxx hepatitidis X - 10 mikrogramů

1f) xxxxxxxx xxxxx xxxxx xxxxxx xxxxxxxxxx B x xxxxxxx formuli

Jedna xxxxx obsahuje:

Antigenum xxxxxxxxx xxxxxxxxxxx B - 20 xxxxxxxxxx

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

Xxxxx xxxxx xxxxxxxx:

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

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

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

¹ pomnoženo xx xxxxxxx kuřecích xxxxxx

² xxxxxxxxx xx xxxxxxxx xxxxxxxxxxx xxxxxxx (MRC-5)

³ 50% xxxxxxxx xxxxx xxxxxxx kultury

NEBO

1h) xxxxxxxx xxxxx xxxxx xxxxxxxxxx, xxxxxxxxxx a xxxxxxxxx

Xx xxxxxxxxxx xxxxxxxx jedna xxxxx (0,5 ml):

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

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

Xxxxx xxxxxxxx² xxxxx attenuatum (xxxx Wistar RA 27/3) ne méně xxx 1x103 XXXX₅₀*

* 50 % xxxxxxxx xxxxx xxxxxxx xxxxxxx

¹ xxxxxxxx na buňkách xxxxxxxx embryí,

² xxxxxxxx xx xxxxxxxx xxxxxxxxxxx xxxxxxxx WI-38 fibroblastech.

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

Xxxxx xxxxx xxxxxxxx:

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

Xxxxx poliomyelitis xxxxxxxxxxx xxxxx 2 (MEF-1) .......8 antigenních X xxxxxxxx*

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

* xxxx xxxxxxxx xxxxxxxxxxxxxx xxxxxxxx stanovené pomocí xxxxxx xxxxxxxxxxxxx xxxxxx.

1x) xxxxxxxx xxxxx xxxxxxxxxxx xxxxx xxxxxxxxxxxxx xxxxxxxx:

Xxxxx xxxxx xxxxxxxx:

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 1¹ 2,2 µx

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 3¹ 2,2 µx

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx sérotypus 4¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 5¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 6A¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 6B¹ 4,4 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 7F¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 9X¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 14¹ 2,2 µx

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 18X¹ 2,2 µg

Streptococci pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 19X¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 19F¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 23X¹ 2,2 µx

¹ Konjugován x xxxxxx proteinem XXX197 x adsorbován xx fosforečnan xxxxxxx (0,125 mg xxxxxxx).

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

Xxxxx xxxxx (0,5 xx) obsahuje:

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

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

Xxxxxxxxxxx xxxxxxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxxx¹- 8 xxxxxxxxxx

Xxxxxxxxx haemagglutinum xxxxxxxxxxxx¹ - 8 xxxxxxxxxx

Xxxxxxxxx¹ 2,5 xxxxxxxxxx

Xxxxx xxxxxxxxxxxxxxx inactivatum:

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

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

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

¹ adsorbováno xx xxxxxxxxxxx xxxxxxxx xxxxxxx (Al(OH)₃) 0,3 xxxxxxxxx Xx³⁺ x xxxxxxxxxxx xxxxxxx (AlPO₄) 0,2 miligramu Xx³⁺

² xxxxxxxxx na XXXX xxxxxxx

1x) xxxxxxxx látka xxxxx xxxxxxxxxxx (XXX xxxxxxx)

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

Xxxxx dávka (0,5 xx) xxxxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxx hepatitidis X^1,2,3 - 20 mikrogramů

¹ xxxxxxxxxx xx XX04X xxxxxxxxxx: - 3-O-deacyl-4'-monofosforyl-lipid X (MPL)2 50 xxxxxxxxxx

² adsorbovaný xx xxxxxxxxxxx xxxxxxx (celkem 0,5 xxxxxxxxx Al³⁺)

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

2. Xxxxxxxxx xxxxxxx xxxxxxxxxx xxxxx pro xxxxxxxx xxxxxxxx

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

Xxxxx xxxxx xxxxxxxx:

Xxxxxxxxx tegiminis xxxxxxxxxxx X - 20 mikrogramů

2b) xxxxxxxx xxxxx xxxxx xxxxxxxxx

2x) xxxxxxxx xxxxx xxxxx xxxxxx hepatitidě A xx xxxxxxx xxx xxxxxxx:

Xxxxx dávka xxxxxxxx:

Xxxxxxxxx X xxxxx inactivatum

2d) xxxxxxxx xxxxx xxxxx xxxxxxxxxx, příušnicím x 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 pro xxxxxxxx xxxxxxx³₅₀

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

¹ xxxxxxxxx na xxxxxxx kuřecích xxxxxx

² xxxxxxxxx xx xxxxxxxx xxxxxxxxxxx xxxxxxx (XXX-5)

³ 50% xxxxxxxx xxxxx xxxxxxx xxxxxx

XXXX

1x) xxxxxxxx xxxxx proti spalničkám, xxxxxxxxxx x xxxxxxxxx

Xx xxxxxxxxxx xxxxxxxx jedna xxxxx (0,5 ml):

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

Xxxxx xxxxxxxxxxx¹ xxxxx xxxxxxxxxx (xxxx Xxxxx Xxxx^XX, hladina X) xx méně xxx 12,5x103 CCID₅₀*

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

* 50 % infekční xxxxx xxxxxxx xxxxxxx

¹ xxxxxxxx xx buňkách xxxxxxxx embryí.

² xxxxxxxx xx lidských xxxxxxxxxxx xxxxxxxx XX-38 xxxxxxxxxxxxx.

3. Xxxxxxxxx xxxxxxx xxxxxxxxxx xxxxx pro xxxxxxxxx xxxxxxxx

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

Xxxxxxxxx X xxxxx xxxxxxxxxxx

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

Xxxxx xxxxxxxxx X inactivatum

 

Ministr:

Mgr. xx Mgr. Vojtěch, XXX, x. x.

Informace

Právní xxxxxxx x. 249/2018 Xx. xxxxx xxxxxxxxx xxxx 15.11.2018.

Ke xxx xxxxxxxx právní xxxxxxx xxxxx xxxxx xx doplňován.

Znění xxxxxxxxxxxx xxxxxxxx norem xxxxxx xxxxxxxx xxxxxxxx x xxxxxxxx xxxx xxxxxxxxxxxxx, xxxxx xx jich xxxxxx xxxxxxxxx xxxxx xxxxx uvedeného xxxxxxxx xxxxxxxx.