Plné znění - 455/2017 Sb.

Sdělení o antigenním složení očkovacích látek pro pravidelná, zvláštní a mimořádná očkování pro rok 2018

455/2017 Sb.

Sdělení Ministerstva zdravotnictví

INFORMACE

455

SDĚLENÍ

Ministerstva xxxxxxxxxxxxx

xx xxx 12. xxxxxxxx 2017

x xxxxxxxxxx složení xxxxxxxxxx xxxxx pro xxxxxxxxxx, xxxxxxxx x xxxxxxxxx xxxxxxxx xxx xxx 2018

 

Xxxxxxxxxxxx zdravotnictví podle §80 xxxx. 1 xxxx. x) xxxxxx x. 258/2000 Xx., x xxxxxxx xxxxxxxxx xxxxxx x o xxxxx xxxxxxxxx souvisejících xxxxxx, xx xxxxx xxxxxxxxxx xxxxxxxx, stanoví xx základě xxxxxxxxxx Xxxxxxx imunizační komise xxxxxxxxx složení očkovacích xxxxx xxx pravidelná, xxxxxxxx x xxxxxxxxx xxxxxxxx xxx xxx 2018:

1. Antigenní xxxxxxx xxxxxxxxxx látek pro xxxxxxxxxx xxxxxxxx

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

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

Xxxxxxxxxxx xxxxxxxxxx¹ xx xxxx xxx 30 mezinárodních xxxxxxxx (XX)

Xxxxxx xxxxxxxxxx¹ xx xxxx xxx 40 xxxxxxxxxxxxx xxxxxxxx (XX)

Xxxxxxxx Xxxxxxxxxx pertussis:

Pertussis xxxxxxxxxx (XX)¹ 25 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxxxx xxxxxxxxxxxx (XXX)¹ 25 mikrogramů

Pertactinum (XXX)¹ 8 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx X (XXx)^2,3 10 mikrogramů

Virus xxxxxxxxxxxxxxx xxxxxxxxxxx (XXX)

xxxxx 1 (xxxx Xxxxxxx)⁴ 40 X xxxxxxxx xxxxxxxx

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

typus 3 (xxxx Xxxxxxx)⁴ 32 X xxxxxxxx xxxxxxxx

Xxxxxxxxxxx xxxxxxxxxx xxxxx b xxxxxxxxxxxxxxx

(Xxxxxxxxxxxxxxxxxxx xxxxxxxx) 10 xxxxxxxxxx

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

¹ xxxxxxxxxxx xx xxxxxxxx hlinitý, hydratovaný (Xx(XX)3) 0,5 xxxxxxxxx Xx³⁺

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

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

⁴ xxxxxxxxx na XXXX xxxxxxx

XXXX

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

Xxxxx xxxxx¹ (0,5 ml) xxxxxxxx:

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

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

Xxxxxxxx Xxxxxxxxxx xxxxxxxxx

Xxxxxxxxx xxxxxxxxxx 25 xxxxxxxxxx

Xxxxxxxxxxxxxx filamentosum 25 xxxxxxxxxx

Xxxxx Poliomyelitidis (inaktivovaný)³

typus 1 (Xxxxxxx) 40 X jednotek xxxxxxxx⁴

xxxxx 2 (XXX-1) 8 X xxxxxxxx xxxxxxxx⁴

xxxxx 3 (Xxxxxxx) 32 X xxxxxxxx xxxxxxxx⁴

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx X⁵ 10 xxxxxxxxxx

Xxxxxxxxxxxxxxxxxxx xxxxxxxx xxxxxxxxxx xxxxxxxxxx X 12 xxxxxxxxxx

(Xxxxxxxxxxxxxxxxxxx phosphas)

conjugata xxx xxxxxx xxxxxxxxxx 22-36 xxxxxxxxxx

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

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

³ xxxxxxxxx xx VERO xxxxxxx

⁴ xxxx ekvivalentní množství xxxxxxxx stanovené xxxxxxx xxxxxxxxxxxxxx xxxxxxx

⁵ xxxxxxxx xxxxxxxxxxxxx XXX technologií x kvasinkových xxxxxxx Xxxxxxxxx polymorpha

1b) očkovací xxxxx xxxxx záškrtu, xxxxxxxx xxxxx (xxxxxxxxxx xxxxx), xxxxxx (XXxX):

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

Xxxxxxxxxxx anatoxinum* ≥ 30 XX

Xxxxxx xxxxxxxxxx* ≥ 40 IU

Pertussis xxxxxxxxxx* (XX) 25 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxxxxx* (XXX) 25 mikrogramů

Pertactinum* (69xX) 8 xxxxxxxxxx

* xxxxxxxxxxx xx xxxxxxxx xxxxxxx xxxxxx: 0,5 xxxxxxxxx

XXXX

1xx) Očkovací látka xxxxx xxxxxxx, xxxxxx x xxxxxxxx xxxxx (xxxxxxxxxx) xx sníženým xxxxxxx xxxxxxxx

Xxxxx xxxxx (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx xxxxxxxxxx - Minimálně 2 XX* (2 Xx)

Xxxxxx anatoxinum - Xxxxxxxxx 20 XX* (5 Xx)

Xxxxxxxxx xxxxxxxx

Xxxxxxxxx xxxxxxxxxx - 2,5 xxxxxxxxxx

Xxxxxxxxxxxxxx filamentosum - 5 xxxxxxxxxx

Xxxxxxxxxxx - 3 mikrogramy

Fimbriae, xxxx 2 xx 3 - 5 xxxxxxxxxx

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

* Xxxx xxxxxx hranice xxxxxxxxx spolehlivosti (x = 0,95) xxxxxxxx xxxxxx xxxxx xxxxx xxxxxxxxx v Xxxxxxxxx xxxxxxxx.

XXXX

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

Xxxxx xxxxx (0,5 ml) xxxxxxxx:

Xxxxxxxxxxx xxxxxxxxxx¹ xx xxxx než 2 xxxxxxxxxxx jednotky (XX) (2,5 Xx)

Xxxxxx anatoxinum¹ xx méně xxx 20 mezinárodních xxxxxxxx (XX) (5 Xx)

Xxxxxxxxxxx xxxxxxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxxx¹ 8 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxx xxxxxxxxxxxx¹ 8 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxx xxxxxxxx proteinum¹ 2,5 xxxxxxxxxx

¹ xxxxxxxxxxx xx xxxxxxxxxxx xxxxxxxx xxxxxxx (Xx(XX)3) 0,3 xxxxxxxxx Al³⁺ a xxxxxxxxxxx xxxxxxx (AlPO4) 0,2 xxxxxxxxx Al³⁺

1c) xxxxxxxx xxxxx xxxxx xxxxxxx vyvolaným Xxxxxxxxxxx xxxxxxxxxx typ x:

Xxxxx xxxxx lyofilizované xxxxxxx xxxxxxxx:

Xxxxxxxxxxxxxxx Xxx purificatum (10 xxxxxxxxxx) xxx Xxxxxxxxx xxxxxxxx (přibližně 25 xxxxxxxxxx).

1x) očkovací xxxxx xxxxx tetanu:

Jedna xxxxx xxxxxxxx:

Xxxxxx xxxxxxxxxx - min. 40 xxxxxxxxxxxxx jednotek

1e) xxxxxxxx xxxxx proti virové xxxxxxxxxx X v xxxxxx xxxxxxx:

Xxxxx dávka xxxxxxxx:

Xxxxxxxxx tegiminis xxxxxxxxxxx X - 10 xxxxxxxxxx

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

Xxxxx xxxxx xxxxxxxx:

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

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

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

¹ pomnoženo na xxxxxxx xxxxxxxx embryí

² xxxxxxxxx na xxxxxxxx xxxxxxxxxxx buňkách (MRC-5)

³ 50% xxxxxxxx xxxxx xxxxxxx xxxxxxx

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

Jedna xxxxx xxxxxxxx:

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

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

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

* xxxx xxxxxxxx xxxxxxxxxxxxxx xxxxxxxx stanovené xxxxxx vhodné imunochemické xxxxxx.

1x) očkovací xxxxx xxxxxxxxxxx proti xxxxxxxxxxxxx xxxxxxxx:

Xxxxx dávka xxxxxxxx:

Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum xxxxxxxxx 1¹ 2,2 µg

Streptococci xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 3¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum sérotypus 4¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 5¹ 2,2 µg

Streptococci xxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 6X¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 6X¹ 4,4 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 7X¹ 2,2 µg

Streptococci xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 9X¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 14¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 18X¹ 2,2 µg

Streptococci xxxxxxxxxx polysaccharidum sérotypus 19X¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum sérotypus 19X¹ 2,2 µg

Streptococci xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 23X¹ 2,2 µg

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

1xx) xxxxxxxx xxxxx xxxxx záškrtu, xxxxxxxx xxxxx (xxxxxxxxxx xxxxx), xxxxxx, dětské xxxxxxxx xxxxx (xxxxxxxxxxxx forma):

Jedna xxxxx (0,5 xx) xxxxxxxx:

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

Xxxxxx xxxxxxxxxx¹ - ne xxxx xxx 20 xxxxxxxxxxxxx jednotek (IU) (5 Lf)

Bordetellae pertussis xxxxxxxx:

Xxxxxxxxx xxxxxxxxxx¹ - 8 xxxxxxxxxx

Xxxxxxxxx haemagglutinum xxxxxxxxxxxx¹ - 8 xxxxxxxxxx

Xxxxxxxxx¹ 2,5 mikrogramů

Virus xxxxxxxxxxxxxxx xxxxxxxxxxx:

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

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

typus 3 (xxxx Xxxxxxx)² - 32 X xxxxxxxx antigenu

¹ adsorbováno xx xxxxxxxxxxx xxxxxxxx xxxxxxx (Al(OH)3) 0,3 xxxxxxxxx Xx³⁺ x xxxxxxxxxxx hlinitý (AlPO4) 0,2 xxxxxxxxx Al³⁺

² xxxxxxxxx xx VERO xxxxxxx

1x) xxxxxxxx xxxxx xxxxx xxxxxxxxxxx (XXX xxxxxxx)

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

Xxxxx xxxxx (0,5 xx) xxxxxxx xxxxxxxx:

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

¹ xxxxxxxxxx xx AS04C xxxxxxxxxx: - 3-X-xxxxxx-4'-xxxxxxxxxxxx-xxxxx X (MPL)2 50 xxxxxxxxxx

² xxxxxxxxxxx na xxxxxxxxxxx hlinitý (xxxxxx 0,5 xxxxxxxxx Xx³⁺)

³ xxxxxxxx xx kultuře xxxxxxxxxxxx buněk (Saccharomyces xxxxxxxxxx) xxxxxxxxxxxxx DNA xxxxxxxxxxx.

1x) Xxxxxxxx xxxxx xxxxx xxxxxx xxxxxxxxxx X ve formuli xxx xxxxxxx:

Xxxxx dávka xxxxxxxx:

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx X - 20 xxxxxxxxxx

2. Xxxxxxxxx xxxxxxx xxxxxxxxxx látek xxx xxxxxxxx očkování

2a) xxxxxxxx xxxxx proti xxxxxx xxxxxxxxxx B xx xxxxxxx xxx dospělé:

Jedna xxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx X - 20 mikrogramů

2b) xxxxxxxx xxxxx proti xxxxxx xxxxxxxxxx X x xxxxxx xxxxxxx:

Xxxxx xxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxx hepatitidis X - 10 xxxxxxxxxx

2x) xxxxxxxx xxxxx xxxxx xxxxxxxxx

2x) xxxxxxxx xxxxx xxxxx xxxxxx xxxxxxxxxx X ve xxxxxxx xxx xxxxxxx:

Xxxxx xxxxx xxxxxxxx:

Xxxxxxxxx X xxxxx xxxxxxxxxxx

2x) očkovací xxxxx proti xxxxxxxxxx, xxxxxxxxxx x xxxxxxxxx

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

Xxxxxxxxxxx xxxxx attenuatum¹ (XXX 4385) xxx. 10^3,7 xxxxxxxx xxxxx xxx xxxxxxxx kulturu³₅₀

Rubeolae xxxxx xxxxxxxxxx² (Xxxxxx XX 27/3) xxx. 10^3,0 xxxxxxxx xxxxx xxx buněčnou kulturu³₅₀

¹ xxxxxxxxx xx xxxxxxx xxxxxxxx xxxxxx

² pomnoženo xx xxxxxxxx xxxxxxxxxxx xxxxxxx (XXX-5)

³ 50% xxxxxxxx dávka tkáňové xxxxxxx

3. Antigenní xxxxxxx xxxxxxxxxx xxxxx xxx xxxxxxxxx xxxxxxxx

3x) xxxxxxxx xxxxx xxxxx virové xxxxxxxxxx A ve xxxxxxx xxx xxxxxxx:

Xxxxxxxxx X virus xxxxxxxxxxx

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

Xxxxx xxxxxxxxx A xxxxxxxxxxx

 

Xxxxxxx:

XXXx. Xxx. Ludvík, XXX, x. x.

Xxxxxxxxx

Xxxxxx xxxxxxx x. 455/2017 Sb. xxxxx xxxxxxxxx xxxx 4.1.2018.

Xx xxxxx tohoto xxxxxxxx xxxxxxxx xxxx xxxxxxxxxx xxxxx x xxxxxxxx xxxxxxxxxxx xxxxxxx xxxxxxxxx x.:

150/2018 Xx., xxxxxx xx xxxx sdělení x. 455/2017 Xx., x xxxxxxxxxx xxxxxxx xxxxxxxxxx xxxxx xxx xxxxxxxxxx, xxxxxxxx x xxxxxxxxx xxxxxxxx xxx xxx 2018

x xxxxxxxxx xx 17.8.2018

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