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 xxxxxxxxxxxxx

xx dne 22. xxxx 2015

x xxxxxxxxxx xxxxxxx očkovacích xxxxx xxx pravidelná, xxxxxxxx a xxxxxxxxx xxxxxxxx xxx xxx 2016

 

Xxxxxxxxxxxx zdravotnictví podle §80 xxxx. 1 xxxx. e) xxxxxx x. 258/2000 Sb., x xxxxxxx xxxxxxxxx xxxxxx x x xxxxx xxxxxxxxx xxxxxxxxxxxxx xxxxxx, ve znění xxxxxxxxxx xxxxxxxx, stanoví xx xxxxxxx doporučení Xxxxxxx xxxxxxxxxx komise xxxxxxxxx xxxxxxx xxxxxxxxxx xxxxx xxx xxxxxxxxxx, xxxxxxxx a xxxxxxxxx xxxxxxxx xxx xxx 2016:

1. Xxxxxxxxx složení xxxxxxxxxx xxxxx pro xxxxxxxxxx očkování

1a) kombinovaná xxxxxxxx látka xxxxx xxxxxxx, xxxxxxxx xxxxx (xxxxxxxxxx xxxxx), xxxxxx, xxxxxx přenosné xxxxx (xxxxxxxxxxxx xxxxx), xxxxxx xxxxxxxxxx B, xxxxxxx xxxxxxxxx Xxxxxxxxxxx xxxxxxxxxx xxx x (XXxXXxxXXXXXX):

Xxxxxxxxxxx xxxxxxxxxx1 xx méně xxx 30 mezinárodních xxxxxxxx (XX)

Xxxxxx anatoxinum1 xx méně než 40 mezinárodních 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 (xxxx Mahoney)4 40 D xxxxxxxx xxxxxxxx

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

xxxxx 3 (xxxx Xxxxxxx)4 32 X xxxxxxxx xxxxxxxx

Xxxxxxxxxxx xxxxxxxxxx xxxxx x xxxxxxxxxxxxxxx 10 xxxxxxxxxx

(xxxxxxxxxxxxxxxxxxx xxxxxxxx)3

xxxxxxxxx xxx xxxxxx xxxxxxxxxx xxxx xxxxxx xxxxxxxxx xxxxxxxxx 25 xxxxxxxxxx

XXXX

1xx) kombinovaná očkovací xxxxx proti záškrtu, xxxxxxxx xxxxx (xxxxxxxxxx xxxxx), tetanu, dětské xxxxxxxx xxxxx (inaktivovaná xxxxx), xxxxxx xxxxxxxxxx X, nákazám xxxxxxxxx Xxxxxxxxxxx xxxxxxxxxx typ x (DTaPHibVHBIPV)

Diphtheriae xxxxxxxxxx xx méně xxx 20 xxxxxxxxxxxxx xxxxxxxx (XX)2

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

Xxxxxxxx Xxxxxxxxxx pertussis

Pertussis xxxxxxxxxx 25 mikrogramů

Haemagglutinum xxxxxxxxxxxx 25 xxxxxxxxxx

Xxxxx Xxxxxxxxxxxxxxx (xxxxxxxxxxxx)3

xxxxx 1 (Mahoney) 40 D xxxxxxxx xxxxxxxx4

xxxxx 2 (XXX-1) 8 X xxxxxxxx xxxxxxxx4

xxxxx 3 (Xxxxxxx) 32 D xxxxxxxx xxxxxxxx4

Xxxxxxxxx xxxxxxxxx xxxxxxxxxx X5 10 xxxxxxxxxx

Xxxxxxxxxxx xxxxxxxxxx typu x xxxxxxxxxxxxxxx 12 xxxxxxxxxx

(Xxxxxxxxxxxxxxxxxxx xxxxxxxx)

xxxxxxxxx xxx tetani 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 jednotek

Pertussis xxxxxxxxxx (XX) 25 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxxxxx (XXX) 25 mikrogramů

Pertactinum (69xX) 8 mikrogramů

NEBO

1ba) Xxxxxxxx xxxxx xxxxx xxxxxxx, xxxxxx x xxxxxxxx xxxxx (xxxxxxxxxx)

1 xxxxx (0,5 xx) xxxxxxxx:	Xxxxxxxxx 2 XX* (2 Xx)
Xxxxxxxxxxx xxxxxxxxxx
Xxxxxx xxxxxxxxxx	Xxxxxxxxx 20 XX* (5 Xx)
Xxxxxxxxx antigeny
Pertussis xxxxxxxxxx	2,5 mikrogramu
Haemagglutinum filamentosum	5 xxxxxxxxxx
Xxxxxxxxxxx	3 mikrogramy
Fimbriae, xxxx 2 et 3	5 xxxxxxxxxx
Xxxxxxxxxxx xx xxxxxxxxxxx xxxxxxx	1,5 xx (0,33 xx hliníku)

NEBO

1bb) Xxxxxxxx xxxxx xxxxx záškrtu, xxxxxx a dávivému xxxxx (xxxxxxxxxx xxxxxxxxxx) xx sníženým obsahem xxxxxxxx

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

Tetani anatoxinum1 xx xxxx xxx 20 xxxxxxxxxxxxx xxxxxxxx (XX) (5 Xx)

Xxxxxxxxxxx xxxxxxxxx antigena:

Pertussis xxxxxxxxxx1 8 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxx xxxxxxxxxxxx1

8 xxxxxxxxxx

Xxxxxxxxx membranae xxxxxxxx proteinum1 2,5 xxxxxxxxxx

1 xxxxxxxxxxx xx xxxxxxxxxxx hydroxid xxxxxxx (XX(XX)3) 0,3 xxxxxxxxx XX3+ x fosforečnan xxxxxxx (AIPO4) 0,2 xxxxxxxxx XX3+

1x) xxxxxxxx xxxxx xxxxx xxxxxxx, xxxxxxxx xxxxx (xxxxxxxxxx xxxxx), xxxxxx, xxxxxxx xxxxxxxxx Xxxxxxxxx xxxxxxxxxx x (DTaPHib):

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

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

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

1e) xxxxxxxx xxxxx xxxxx xxxxxx:

Xxxxxx anatoxinum ... xxx. 40 xxxxxxxxxxxxx xxxxxxxx

1x) očkovací xxxxx xxxxx xxxxxx xxxxxxxxxx X xx 16 xxx a xxxx:

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx X ... 20 mikrogramů

1g) xxxxxxxx látka proti xxxxxxxxxx, xxxxxxxxxx a xxxxxxxxx:

Xxxxxxxxxxx xxxxx attenuatum (Xxxxxxx) xxx. 103,0 xxxxxxxx xxxxx pro xxxxxxxx kulturu₅₀

Parotitidis xxxxx xxxxxxxxxx (RIT 4385) xxx. 103,7 xxxxxxxx xxxxx pro buněčnou xxxxxxx₅₀

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

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

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

Xxxxx xxxxxxxxxxxxx xxxxxxxxxxx typus 2 (XXX-1) ......... 8 xxxxxxxxxxx X jednotek*

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

* xxxx xxxxxxxx xxxxxxxxxxxxxx xxxxxxxx stanovené xxxxxx vhodné imunochemické xxxxxx.

1xx) xxxxxxxx xxxxx xxxxx xxxxxxx xxxxxxxxx Xxxxxxxxxxxxx xxxxxxxxxx x xxxxxxxxxxxxxxx xxxxxxx:

Xxxxxxxxxxxxxxx Xxxxxxxxxxxx xxxxxxxxxx typus:

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

1x) xxxxxxxx xxxxx xxxxxxxxxxx xxxxx pneumokokovým xxxxxxxx:

Xxxxxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 1

Pneumococcale xxxxxxxxxxxxxxx sérotypus 3

Xxxxxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 4

Xxxxxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 5

Xxxxxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 6A

Pneumococcale xxxxxxxxxxxxxxx xxxxxxxxx 6B

Pneumococcale xxxxxxxxxxxxxxx sérotypus 7X

Xxxxxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 9V

Pneumococcale xxxxxxxxxxxxxxx xxxxxxxxx 14

Pneumococcale xxxxxxxxxxxxxxx xxxxxxxxx 18C

Pneumococcale xxxxxxxxxxxxxxx xxxxxxxxx 19X

Xxxxxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 19X

Xxxxxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 23F

1j) xxxxxxxx xxxxx proti xxxxxxx, xxxxxxxx xxxxx (xxxxxxxxxx xxxxx), tetanu, xxxxxx přenosné xxxxx (xxxxxxxxxxxx forma):

Diphtheriae xxxxxxxxxx	xx xxxx xxx 2 xxxxxxxxxxx jednotky
Tetani xxxxxxxxxx	xx xxxx xxx 20 xxxxxxxxxxxxx xxxxxxxx

Xxxxxxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxxx	8 xxxxxxxxxx
Xxxxxxxxx xxxxxxxxxxxxxx xxxxxxxxxxxx	8 xxxxxxxxxx
Xxxxxxxxx	2,5 mikrogramů

Virus xxxxxxxxxxxxxxx inactivatum:

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

NEBO

1ja) očkovací xxxxx xxxxx xxxxxxx, xxxxxxxx kašli (xxxxxxxxxx xxxxx), xxxxxx, dětské xxxxxxxx obrně (inaktivovaná xxxxx):

Xxxxxxxxxx xxxxxx	xxxx xxxx xxxxx 2 xxxxxxxxxxx xxxxxxxx (2 Xx)
Xxxxxxxxx xxxxxx	xxxx xxxx rovno 20 xxxxxxxxxxxxx jednotek (5 Lf)

Pertusové xxxxxxxx:

Xxxxxxxxx xxxxxx	2,5 xxxxxxxxxx
Xxxxxxxxxxxx hemaglutinin	5 xxxxxxxxxx
Xxxxxxx typu 2+3	5 xxxxxxxxxx
Xxxxxxxxx	3 mikrogramy

-

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

1x) očkovací xxxxx xxxxx xxxxxxxxxxx:

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

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

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

Xxxxxxxxx tegiminis hepatitidis X xxxxxxxxxxxxxx 20 xxxxxxxxxx; xxxxxxxx AS04C xxxxxxxxxx 3-O-deacyl-4-monofosforyl-lipid X (XXX) 50 xxxxxxxxxx x 1 xxxxx

1x) Xxxxxxxx xxxxx proti xxxxxx xxxxxxxxxx X x xxxxxx xxxxxxx:

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

2. Xxxxxxxxx složení xxxxxxxxxx xxxxx xxx xxxxxxxx xxxxxxxx

2x) očkovací látka xxxxx xxxxxx hepatitidě X ve xxxxxxx xxx dospělé:

Xxxxxxxxx xxxxxxxxx hepatitidis B ... 20 xxxxxxxxxx

2x) xxxxxxxx xxxxx xxxxx xxxxxxxxx

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

2x) xxxxxxxx látka xxxxx xxxxxx xxxxxxxxxx X xx xxxxxxx xxx xxxxxxx:

Xxxxxxxxx X xxxxx xxxxxxxxxxx

3. Xxxxxxxxx xxxxxxx xxxxxxxxxx látek xxx xxxxxxxxx xxxxxxxx

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

Xxxxxxxxx X xxxxx xxxxxxxxxxx

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

Xxxxx xxxxxxxxx X xxxxxxxxxxx

 

X xxxx 2016 x xxxxxxx xx xxxxxxxxxx xxxxxxxxxx xxxxxxxx č. 537/2006 Sb., x xxxxxxxx xxxxx xxxxxxxxx xxxxxxx, ve xxxxx xxxxxxxxxx xxxxxxxx, nelze xxxxxxxx případnou xxxxxx xxxxxxxxxxx xxxxxxx očkovacích xxxxx pro pravidelná xxxxxxxx publikováním xxxxxx xxxxxxxxxxx xxxxxxx těchto xxxxxxxxxx xxxxx xx Xxxxxx zákonů.

 

Ministr:

v z. XXXx. Xxxxxxx x. x.

xxxxxxxx xxx xxxxxxxxxxx x xxxxx

Xxxxxxxxx

Xxxxxx předpis x. 261/2015 Xx. nabyl xxxxxxxxx xxxx 24.10.2015.

Ve xxxxx xxxxxx právního xxxxxxxx xxxx xxxxxxxxxx xxxxx x doplnění xxxxxxxxxxx právním předpisem x.:

131/2016 Sb., xxxxxx xx xxxx sdělení x. 261/2015 Xx., x xxxxxxxxxx xxxxxxx xxxxxxxxxx xxxxx xxx xxxxxxxxxx, xxxxxxxx x xxxxxxxxx xxxxxxxx xxx xxx 2016

x účinností xx 10.5.2016

Xxxxx xxxxxxxxxxxx xxxxxxxx xxxxx xxxxxx xxxxxxxx xxxxxxxx x xxxxxxxx xxxx xxxxxxxxxxxxx, xxxxx xx xxxx xxxxxx derogační xxxxx xxxxx xxxxxxxxx právního xxxxxxxx.