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 zdravotnictví

ze xxx 12. xxxxxxxx 2017

x xxxxxxxxxx xxxxxxx xxxxxxxxxx xxxxx xxx xxxxxxxxxx, xxxxxxxx x mimořádná xxxxxxxx xxx rok 2018

 

Xxxxxxxxxxxx xxxxxxxxxxxxx podle §80 xxxx. 1 xxxx. x) xxxxxx x. 258/2000 Xx., x xxxxxxx xxxxxxxxx xxxxxx x x xxxxx xxxxxxxxx souvisejících xxxxxx, xx xxxxx xxxxxxxxxx xxxxxxxx, stanoví xx xxxxxxx doporučení Xxxxxxx xxxxxxxxxx komise xxxxxxxxx xxxxxxx xxxxxxxxxx xxxxx xxx xxxxxxxxxx, xxxxxxxx x xxxxxxxxx xxxxxxxx xxx xxx 2018:

1. Xxxxxxxxx xxxxxxx xxxxxxxxxx xxxxx xxx xxxxxxxxxx xxxxxxxx

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

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

Xxxxxxxxxxx xxxxxxxxxx¹ xx xxxx xxx 30 mezinárodních xxxxxxxx (XX)

Xxxxxx xxxxxxxxxx¹ xx xxxx xxx 40 mezinárodních xxxxxxxx (XX)

Xxxxxxxx Xxxxxxxxxx pertussis:

Pertussis xxxxxxxxxx (PT)¹ 25 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxxxx xxxxxxxxxxxx (XXX)¹ 25 xxxxxxxxxx

Xxxxxxxxxxx (XXX)¹ 8 xxxxxxxxxx

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

Xxxxx xxxxxxxxxxxxxxx xxxxxxxxxxx (IPV)

typus 1 (xxxx Xxxxxxx)⁴ 40 D jednotek 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 phosphas) 10 xxxxxxxxxx

xxxx. cum xxxxxx. xxxxxxxx jako nosný xxxxxxx xxxxxxxxx 25 xxxxxxxxxx

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

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

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

⁴ xxxxxxxxx na XXXX buňkách

NEBO

1aa) kombinovaná xxxxxxxx xxxxx xxxxx xxxxxxx, xxxxxxxx xxxxx (xxxxxxxxxx xxxxx), xxxxxx, xxxxxx xxxxxxxx xxxxx (xxxxxxxxxxxx forma), xxxxxx xxxxxxxxxx X, xxxxxxx xxxxxxxxx Haemophilus influenzae xxx b (XXxXXxxXXXXXX)

Xxxxx xxxxx¹ (0,5 xx) xxxxxxxx:

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

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

Antigeny Xxxxxxxxxx xxxxxxxxx

Xxxxxxxxx xxxxxxxxxx 25 xxxxxxxxxx

Xxxxxxxxxxxxxx filamentosum 25 xxxxxxxxxx

Xxxxx Xxxxxxxxxxxxxxx (xxxxxxxxxxxx)³

xxxxx 1 (Xxxxxxx) 40 X xxxxxxxx xxxxxxxx⁴

xxxxx 2 (MEF-1) 8 X jednotek xxxxxxxx⁴

xxxxx 3 (Saukett) 32 X jednotek antigenu⁴

Antigenum xxxxxxxxx xxxxxxxxxxx B⁵ 10 mikrogramů

Polyribosylribitoli phosphas xxxxxxxxxx xxxxxxxxxx X 12 xxxxxxxxxx

(Xxxxxxxxxxxxxxxxxxx xxxxxxxx)

xxxxxxxxx xxx tetani xxxxxxxxxx 22-36 xxxxxxxxxx

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

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

³ pomnoženo xx XXXX xxxxxxx

⁴ xxxx xxxxxxxxxxxx množství xxxxxxxx stanovené xxxxxxx xxxxxxxxxxxxxx metodou

⁵ xxxxxxxx xxxxxxxxxxxxx DNA technologií x kvasinkových buňkách Xxxxxxxxx polymorpha

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

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

Xxxxxxxxxxx xxxxxxxxxx* ≥ 30 XX

Xxxxxx xxxxxxxxxx* ≥ 40 XX

Xxxxxxxxx xxxxxxxxxx* (XX) 25 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxxx filamentosum* (XXX) 25 mikrogramů

Pertactinum* (69xX) 8 mikrogramů

* xxxxxxxxxxx xx xxxxxxxx xxxxxxx xxxxxx: 0,5 xxxxxxxxx

XXXX

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

Xxxxx dávka (0,5 ml) xxxxxxxx:

Xxxxxxxxxxx xxxxxxxxxx - Xxxxxxxxx 2 IU* (2 Xx)

Xxxxxx xxxxxxxxxx - Xxxxxxxxx 20 IU* (5 Xx)

Xxxxxxxxx xxxxxxxx

Xxxxxxxxx xxxxxxxxxx - 2,5 xxxxxxxxxx

Xxxxxxxxxxxxxx filamentosum - 5 xxxxxxxxxx

Xxxxxxxxxxx - 3 xxxxxxxxxx

Xxxxxxxx, typi 2 et 3 - 5 xxxxxxxxxx

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

* Xxxx xxxxxx xxxxxxx xxxxxxxxx xxxxxxxxxxxxx (x = 0,95) xxxxxxxx xxxxxx xxxxx xxxxx xxxxxxxxx x Evropském xxxxxxxx.

XXXX

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

Xxxxx xxxxx (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx anatoxinum¹ xx xxxx než 2 xxxxxxxxxxx jednotky (XX) (2,5 Lf)

Tetani xxxxxxxxxx¹ xx xxxx než 20 mezinárodních xxxxxxxx (XX) (5 Xx)

Xxxxxxxxxxx xxxxxxxxx antigena:

Pertussis xxxxxxxxxx¹ 8 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxx xxxxxxxxxxxx¹ 8 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxx externae xxxxxxxxx¹ 2,5 mikrogramů

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

1x) xxxxxxxx látka xxxxx xxxxxxx xxxxxxxxx Xxxxxxxxxxx xxxxxxxxxx typ b:

Jedna xxxxx lyofilizované xxxxxxx xxxxxxxx:

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

1x) xxxxxxxx xxxxx proti xxxxxx:

Xxxxx xxxxx xxxxxxxx:

Xxxxxx xxxxxxxxxx - xxx. 40 xxxxxxxxxxxxx jednotek

1e) xxxxxxxx xxxxx proti xxxxxx xxxxxxxxxx X x xxxxxx xxxxxxx:

Xxxxx dávka xxxxxxxx:

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx X - 10 xxxxxxxxxx

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

Xxxxx dávka xxxxxxxx:

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

¹ pomnoženo na xxxxxxx xxxxxxxx xxxxxx

² xxxxxxxxx na lidských xxxxxxxxxxx buňkách (XXX-5)

³ 50% xxxxxxxx xxxxx xxxxxxx xxxxxxx

1x) xxxxxxxx xxxxx proti dětské xxxxxxxx obrně x xxxxxxxxxxxx formě:

Jedna xxxxx xxxxxxxx:

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

Virus xxxxxxxxxxxxx xxxxxxxxxxx xxxxx 2 (MEF-1).....8 xxxxxxxxxxx X xxxxxxxx*

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

* xxxx množství xxxxxxxxxxxxxx xxxxxxxx xxxxxxxxx xxxxxx xxxxxx xxxxxxxxxxxxx xxxxxx.

1x) xxxxxxxx látka xxxxxxxxxxx proti xxxxxxxxxxxxx xxxxxxxx:

Xxxxx xxxxx xxxxxxxx:

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 1¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum sérotypus 3¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 4¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 5¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 6X¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 6X¹ 4,4 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 7X¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum xxxxxxxxx 9X¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 14¹ 2,2 µg

Streptococci xxxxxxxxxx polysaccharidum xxxxxxxxx 18X¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 19X¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 19X¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 23X¹ 2,2 µg

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

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

Jedna xxxxx (0,5 ml) xxxxxxxx:

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

Xxxxxx xxxxxxxxxx¹ - ne xxxx než 20 xxxxxxxxxxxxx xxxxxxxx (XX) (5 Lf)

Bordetellae xxxxxxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxxx¹ - 8 xxxxxxxxxx

Xxxxxxxxx haemagglutinum xxxxxxxxxxxx¹ - 8 xxxxxxxxxx

Xxxxxxxxx¹ 2,5 xxxxxxxxxx

Xxxxx xxxxxxxxxxxxxxx xxxxxxxxxxx:

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

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

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

¹ xxxxxxxxxxx xx xxxxxxxxxxx xxxxxxxx xxxxxxx (Xx(XX)3) 0,3 xxxxxxxxx Al³⁺ x xxxxxxxxxxx xxxxxxx (XxXX4) 0,2 xxxxxxxxx Xx³⁺

² xxxxxxxxx xx XXXX xxxxxxx

1x) očkovací xxxxx xxxxx tuberkulóze (XXX xxxxxxx)

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

Xxxxx xxxxx (0,5 xx) xxxxxxx xxxxxxxx:

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

¹ xxxxxxxxxx xx AS04C xxxxxxxxxx: - 3-O-deacyl-4'-monofosforyl-lipid X (XXX)2 50 xxxxxxxxxx

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

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

2. Xxxxxxxxx xxxxxxx xxxxxxxxxx xxxxx pro xxxxxxxx xxxxxxxx

2x) očkovací xxxxx xxxxx virové xxxxxxxxxx X xx xxxxxxx pro xxxxxxx:

Xxxxx xxxxx obsahuje:

Antigenum xxxxxxxxx xxxxxxxxxxx B - 20 xxxxxxxxxx

2x) xxxxxxxx xxxxx xxxxx xxxxxx xxxxxxxxxx X v xxxxxx xxxxxxx:

Xxxxx dávka xxxxxxxx:

Xxxxxxxxx tegiminis xxxxxxxxxxx X - 10 xxxxxxxxxx

2x) xxxxxxxx xxxxx xxxxx xxxxxxxxx

2x) xxxxxxxx xxxxx xxxxx virové xxxxxxxxxx X ve xxxxxxx pro xxxxxxx:

Xxxxx xxxxx xxxxxxxx:

Xxxxxxxxx X xxxxx xxxxxxxxxxx

2x) očkovací xxxxx xxxxx xxxxxxxxxx, xxxxxxxxxx x xxxxxxxxx

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

Xxxxxxxxxxx xxxxx xxxxxxxxxx¹ (XXX 4385) xxx. 10^3,7 xxxxxxxx xxxxx xxx xxxxxxxx kulturu³₅₀

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

¹ xxxxxxxxx na xxxxxxx xxxxxxxx xxxxxx

² xxxxxxxxx xx lidských xxxxxxxxxxx xxxxxxx (XXX-5)

³ 50% xxxxxxxx dávka xxxxxxx xxxxxxx

3. Xxxxxxxxx složení xxxxxxxxxx xxxxx xxx xxxxxxxxx xxxxxxxx

3x) xxxxxxxx xxxxx xxxxx xxxxxx xxxxxxxxxx X xx xxxxxxx pro dospělé:

Hepatitis X virus inactivatum

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

Xxxxx hepatitis X xxxxxxxxxxx

 

Xxxxxxx:

XXXx. Ing. Xxxxxx, XXX, x. x.

Informace

Právní xxxxxxx x. 455/2017 Xx. nabyl xxxxxxxxx xxxx 4.1.2018.

Ve xxxxx xxxxxx xxxxxxxx xxxxxxxx xxxx xxxxxxxxxx xxxxx a xxxxxxxx xxxxxxxxxxx xxxxxxx xxxxxxxxx x.:

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

x účinností xx 17.8.2018

Znění xxxxxxxxxxxx xxxxxxxx xxxxx xxxxxx xxxxxxxx předpisů x xxxxxxxx není xxxxxxxxxxxxx, xxxxx xx xxxx xxxxxx xxxxxxxxx xxxxx xxxxx uvedeného xxxxxxxx xxxxxxxx.