Plné znění - 261/2015 Sb.

Sdělení o antigenním složení očkovacích látek pro pravidelná, zvláštní a mimořádná očkování pro rok 2016

261/2015 Sb.

Sdělení Ministerstva zdravotnictví

INFORMACE

261

XXXXXXX

Xxxxxxxxxxxx zdravotnictví

ze xxx 22. xxxx 2015

o xxxxxxxxxx složení xxxxxxxxxx xxxxx xxx xxxxxxxxxx, xxxxxxxx x xxxxxxxxx xxxxxxxx xxx xxx 2016

 

Xxxxxxxxxxxx xxxxxxxxxxxxx xxxxx §80 xxxx. 1 xxxx. x) zákona x. 258/2000 Xx., x xxxxxxx xxxxxxxxx xxxxxx a x xxxxx xxxxxxxxx xxxxxxxxxxxxx xxxxxx, ve xxxxx xxxxxxxxxx xxxxxxxx, xxxxxxx xx základě doporučení Xxxxxxx xxxxxxxxxx komise xxxxxxxxx složení xxxxxxxxxx xxxxx xxx xxxxxxxxxx, xxxxxxxx x mimořádná xxxxxxxx xxx xxx 2016:

1. Xxxxxxxxx složení xxxxxxxxxx látek xxx xxxxxxxxxx xxxxxxxx

1x) kombinovaná xxxxxxxx xxxxx xxxxx xxxxxxx, dávivému xxxxx (xxxxxxxxxx xxxxx), xxxxxx, xxxxxx xxxxxxxx xxxxx (xxxxxxxxxxxx forma), xxxxxx xxxxxxxxxx X, nákazám xxxxxxxxx Xxxxxxxxxxx xxxxxxxxxx xxx x (XXxXXxxXXXXXX):

Xxxxxxxxxxx xxxxxxxxxx1 xx xxxx xxx 30 xxxxxxxxxxxxx xxxxxxxx (XX)

Xxxxxx xxxxxxxxxx1 xx méně než 40 xxxxxxxxxxxxx xxxxxxxx (XX)

Xxxxxxxx Bordetelly xxxxxxxxx:

Xxxxxxxxx xxxxxxxxxx1 25 xxxxxxxxxx

Xxxxxxxxxxxxxxxx xxxxxxxxxxxx1 25 xxxxxxxxxx

Xxxxxxxxxxx1 8 mikrogramů

Antigenum xxxxxxxxx xxxxxxxxxxx X2,3 10 xxxxxxxxxx

Xxxxx xxxxxxxxxxxxx (xxxxxxxxxxxx)

xxxxx 1 (kmen Xxxxxxx)4 40 D xxxxxxxx xxxxxxxx

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

xxxxx 3 (xxxx Saukett)4 32 X xxxxxxxx xxxxxxxx

Xxxxxxxxxxx xxxxxxxxxx typus x xxxxxxxxxxxxxxx 10 xxxxxxxxxx

(xxxxxxxxxxxxxxxxxxx xxxxxxxx)3

xxxxxxxxx xxx tetani xxxxxxxxxx xxxx xxxxxx xxxxxxxxx xxxxxxxxx 25 xxxxxxxxxx

XXXX

1xx) xxxxxxxxxxx očkovací xxxxx proti záškrtu, xxxxxxxx xxxxx (xxxxxxxxxx xxxxx), xxxxxx, xxxxxx xxxxxxxx xxxxx (xxxxxxxxxxxx xxxxx), xxxxxx xxxxxxxxxx X, xxxxxxx xxxxxxxxx Xxxxxxxxxxx influenzae typ x (DTaPHibVHBIPV)

Diphtheriae anatoxinum xx xxxx než 20 mezinárodních jednotek (XX)2

Xxxxxx xxxxxxxxxx ne xxxx než 40 xxxxxxxxxxxxx jednotek (XX)2

Xxxxxxxx Xxxxxxxxxx xxxxxxxxx

Xxxxxxxxx xxxxxxxxxx 25 mikrogramů

Haemagglutinum xxxxxxxxxxxx 25 xxxxxxxxxx

Xxxxx Poliomyelitidis (xxxxxxxxxxxx)3

xxxxx 1 (Xxxxxxx) 40 X xxxxxxxx xxxxxxxx4

xxxxx 2 (XXX-1) 8 X xxxxxxxx xxxxxxxx4

xxxxx 3 (Xxxxxxx) 32 X jednotek xxxxxxxx4

Xxxxxxxxx xxxxxxxxx hepatitidy X5 10 xxxxxxxxxx

Xxxxxxxxxxx xxxxxxxxxx xxxx b xxxxxxxxxxxxxxx 12 xxxxxxxxxx

(Xxxxxxxxxxxxxxxxxxx xxxxxxxx)

xxxxxxxxx xxx xxxxxx xxxxxxxxxx 22-36 mikrogramů

1b) xxxxxxxx xxxxx xxxxx xxxxxxx, xxxxxxxx kašli (xxxxxxxxxx xxxxx), xxxxxx (XXxX):

Xxxxxxxxxxx xxxxxxxxxx&xxxx;≥ 30 xxxxxxxxxxxxx xxxxxxxx

Xxxxxx xxxxxxxxxx&xxxx;≥ 40 xxxxxxxxxxxxx xxxxxxxx

Xxxxxxxxx xxxxxxxxxx (XX) 25 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxxxxx (XXX) 25 mikrogramů

Pertactinum (69xX) 8 xxxxxxxxxx

XXXX

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

1 xxxxx (0,5 ml) xxxxxxxx:	Xxxxxxxxx 2 IU* (2 Xx)
Xxxxxxxxxxx xxxxxxxxxx
Xxxxxx xxxxxxxxxx	Xxxxxxxxx 20 XX* (5 Xx)
Xxxxxxxxx xxxxxxxx
Xxxxxxxxx xxxxxxxxxx	2,5 xxxxxxxxxx
Xxxxxxxxxxxxxx filamentosum	5 xxxxxxxxxx
Xxxxxxxxxxx	3 xxxxxxxxxx
Xxxxxxxx, xxxx 2 xx 3	5 xxxxxxxxxx
Xxxxxxxxxxx xx xxxxxxxxxxx xxxxxxx	1,5 mg (0,33 xx hliníku)

NEBO

1bb) Očkovací xxxxx xxxxx xxxxxxx, xxxxxx x dávivému xxxxx (xxxxxxxxxx komponenta) xx xxxxxxxx obsahem xxxxxxxx

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

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

Xxxxxxxxxxx xxxxxxxxx xxxxxxxx:

Xxxxxxxxx anatoxinum1 8 mikrogramů

Pertussis xxxxxxxxxxxxxx xxxxxxxxxxxx1

8 mikrogramů

Pertussis 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 AI3+

1c) xxxxxxxx xxxxx proti xxxxxxx, xxxxxxxx kašli (xxxxxxxxxx xxxxx), xxxxxx, nákazám xxxxxxxxx Xxxxxxxxx xxxxxxxxxx x (XXxXXxx):

Xxxxxxxxxxx xxxxxxxxxx	xxx. 30 mezinárodních xxxxxxxx
Xxxxxx xxxxxxxxxx	xxx. 40 mezinárodních xxxxxxxx
Xxxxxxxxx xxxxxxxxxx (XX)	25 xxxxxxxxxx
Xxxxxxxxx haemaglutininum xxxxxxxxxxxx (XXX)	25 mikrogramů
Pertactinum (69xX)	8 xxxxxxxxxx
Xxxxxxxxxxx xxxxxxxxxx X	10 xxxxxxxxxx
xxx anatoxino xxxxxxxx	20-40 xxxxxxxxxx

1x) xxxxxxxx látka xxxxx nákazám vyvolaným Xxxxxxxxxxx xxxxxxxxxx xxx x:

1 dávka xxxxxxxxxxxxx xxxxxxx xxxxxxxx: Polysaccharidum Xxx purificatum (10 xxxxxxxxxx) xxx Xxxxxxxxx xxxxxxxx (25 xxxxxxxxxx).

1x) xxxxxxxx xxxxx proti xxxxxx:

Xxxxxx xxxxxxxxxx ... xxx. 40 mezinárodních xxxxxxxx

1x) očkovací látka xxxxx virové xxxxxxxxxx X xx 16 xxx x xxxx:

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx B ... 20 xxxxxxxxxx

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

Xxxxxxxxxxx xxxxx xxxxxxxxxx (Xxxxxxx) xxx. 103,0 xxxxxxxx dávka xxx xxxxxxxx kulturu₅₀

Parotitidis virus xxxxxxxxxx (XXX 4385) xxx. 103,7 xxxxxxxx xxxxx pro xxxxxxxx xxxxxxx₅₀

Xxxxxxxx virus xxxxxxxxxx (Xxxxxx XX 27/3) xxx. 103,0 xxxxxxxx xxxxx xxx buněčnou xxxxxxx₅₀

1x) xxxxxxxx látka xxxxx xxxxxx xxxxxxxx xxxxx x xxxxxxxxxxxx xxxxx:

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

Xxxxx poliomyelitis xxxxxxxxxxx xxxxx 2 (XXX-1) ......... 8 xxxxxxxxxxx D jednotek*

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

* nebo xxxxxxxx xxxxxxxxxxxxxx xxxxxxxx xxxxxxxxx xxxxxx xxxxxx xxxxxxxxxxxxx xxxxxx.

1xx) xxxxxxxx xxxxx xxxxx xxxxxxx vyvolaným Xxxxxxxxxxxxx xxxxxxxxxx x xxxxxxxxxxxxxxx formuli:

Polysaccharidum Streptococci xxxxxxxxxx xxxxx:

1, 2, 3, 4, 5, 6X, 7X, 8, 9X, 9X, 10X, 11X, 12F, 14, 15X, 17F, 18C, 19X, 19X, 20, 22X, 23X, 33X ... 25 mikrogramů x každého sérotypu

1i) xxxxxxxx látka xxxxxxxxxxx xxxxx xxxxxxxxxxxxx xxxxxxxx:

Xxxxxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 1

Xxxxxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 3

Xxxxxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 4

Xxxxxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 5

Xxxxxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 6X

Xxxxxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 6X

Xxxxxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 7X

Xxxxxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 9V

Pneumococcale xxxxxxxxxxxxxxx xxxxxxxxx 14

Xxxxxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 18C

Pneumococcale xxxxxxxxxxxxxxx xxxxxxxxx 19A

Pneumococcale xxxxxxxxxxxxxxx xxxxxxxxx 19F

Pneumococcale xxxxxxxxxxxxxxx sérotypus 23X

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

Xxxxxxxxxxx anatoxinum	ne xxxx než 2 xxxxxxxxxxx jednotky
Tetani xxxxxxxxxx	xx xxxx xxx 20 xxxxxxxxxxxxx jednotek

Pertusové xxxxxxxx:

Xxxxxxxxx xxxxxxxxxx	8 xxxxxxxxxx
Xxxxxxxxx haemagglutinum xxxxxxxxxxxx	8 mikrogramů
Pertaktin	2,5 mikrogramů

Virus xxxxxxxxxxxxxxx xxxxxxxxxxx:

xxxxx 1 (xxxx Mahoney)	40 X xxxxxxxx xxxxxxxx
xxxxx 2 (xxxx XXX-1)	8 X xxxxxxxx xxxxxxxx
xxxxx 3 (xxxx Xxxxxxx)	32 X xxxxxxxx antigenu

NEBO

1ja) xxxxxxxx xxxxx xxxxx xxxxxxx, xxxxxxxx kašli (xxxxxxxxxx xxxxx), xxxxxx, xxxxxx xxxxxxxx obrně (xxxxxxxxxxxx xxxxx):

Xxxxxxxxxx xxxxxx	xxxx xxxx xxxxx 2 mezinárodní xxxxxxxx (2 Xx)
Xxxxxxxxx xxxxxx	xxxx nebo xxxxx 20 xxxxxxxxxxxxx xxxxxxxx (5 Xx)

Xxxxxxxxx xxxxxxxx:

Xxxxxxxxx xxxxxx	2,5 mikrogramu
Filamentózní xxxxxxxxxxxx	5 xxxxxxxxxx
Xxxxxxx xxxx 2+3	5 xxxxxxxxxx
Xxxxxxxxx	3 xxxxxxxxxx

-

Xxxxx poliomyelitis xxxx 1 (xxxxxxxxxxxx)	40 xxxxxxxxxxx X xxxxxxxx
Xxxxx xxxxxxxxxxxxx xxxx 2 (xxxxxxxxxxxx)	8 antigenních X xxxxxxxx
Xxxxx poliomyelitis typu 3 (inaktivovaný)	32 xxxxxxxxxxx X jednotek

1l) xxxxxxxx xxxxx xxxxx xxxxxxxxxxx:

Xxxxxxxxxxxxx xxxxx xxxxxxxxxx (XXX) xxxxxxx Xxxxxxx 1331.....0,75 xx

&xx;2,0 x 10⁶ ≤ 8,0 x 10⁶ CFU (xxxxxx xxxxxxx)

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

Xxxxxxxxx tegiminis xxxxxxxxxxx X xxxxxxxxxxxxxx 20 xxxxxxxxxx; adjuvans XX04X xxxxxxxxxx 3-X-xxxxxx-4-xxxxxxxxxxxx-xxxxx X (XXX) 50 xxxxxxxxxx x 1 dávce

1n) Xxxxxxxx látka xxxxx xxxxxx xxxxxxxxxx B x xxxxxx xxxxxxx:

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx X 10 xxxxxxxxxx x 0,5 xx suspenze

2. Xxxxxxxxx xxxxxxx očkovacích xxxxx xxx xxxxxxxx xxxxxxxx

2x) očkovací xxxxx xxxxx xxxxxx xxxxxxxxxx X ve formuli xxx dospělé:

Xxxxxxxxx xxxxxxxxx hepatitidis B ... 20 mikrogramů

2b) xxxxxxxx xxxxx xxxxx xxxxxxxxx

Xxxxx xxxxxx xxxxxxxxxxx (xxxx Wistar xxxxxx XX/XX 38&xxxx;1503-3X více xxxx xxxxx 2,5 xxxxxxxxxxxxx xxxxxxxx v 1 xxxxx (0,5 xx)

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

Xxxxxxxxx X xxxxx inactivatum

3. Antigenní xxxxxxx xxxxxxxxxx látek xxx mimořádná xxxxxxxx

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

Xxxxxxxxx A virus xxxxxxxxxxx

3x) xxxxxxxx látka xxxxx xxxxxx hepatitidě X xx xxxxxxx xxx děti:

Virus xxxxxxxxx X xxxxxxxxxxx

 

X xxxx 2016 x xxxxxxx xx plánovanou novelizaci xxxxxxxx č. 537/2006 Sb., x xxxxxxxx proti xxxxxxxxx xxxxxxx, xx xxxxx xxxxxxxxxx předpisů, xxxxx xxxxxxxx xxxxxxxxx xxxxxx xxxxxxxxxxx xxxxxxx xxxxxxxxxx xxxxx xxx xxxxxxxxxx xxxxxxxx publikováním nového xxxxxxxxxxx xxxxxxx těchto xxxxxxxxxx látek ve Xxxxxx zákonů.

 

Ministr:

v x. XXXx. Policar x. x.

xxxxxxxx pro xxxxxxxxxxx x xxxxx

Xxxxxxxxx

Xxxxxx xxxxxxx č. 261/2015 Xx. xxxxx xxxxxxxxx xxxx 24.10.2015.

Xx xxxxx xxxxxx právního xxxxxxxx xxxx podchyceny xxxxx x xxxxxxxx xxxxxxxxxxx xxxxxxx předpisem x.:

131/2016 Xx., xxxxxx xx xxxx xxxxxxx x. 261/2015 Xx., x xxxxxxxxxx složení xxxxxxxxxx látek xxx xxxxxxxxxx, xxxxxxxx a xxxxxxxxx xxxxxxxx xxx xxx 2016

x účinností xx 10.5.2016

Xxxxx xxxxxxxxxxxx xxxxxxxx xxxxx xxxxxx xxxxxxxx předpisů x xxxxxxxx xxxx xxxxxxxxxxxxx, xxxxx xx jich xxxxxx xxxxxxxxx xxxxx xxxxx xxxxxxxxx xxxxxxxx xxxxxxxx.