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 xxx 22. září 2015

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

 

Xxxxxxxxxxxx xxxxxxxxxxxxx xxxxx §80 xxxx. 1 xxxx. x) zákona x. 258/2000 Xx., x xxxxxxx xxxxxxxxx xxxxxx x x xxxxx některých souvisejících xxxxxx, xx xxxxx xxxxxxxxxx xxxxxxxx, xxxxxxx xx základě doporučení Xxxxxxx imunizační xxxxxx xxxxxxxxx xxxxxxx xxxxxxxxxx xxxxx xxx pravidelná, xxxxxxxx x mimořádná xxxxxxxx xxx xxx 2016:

1. Xxxxxxxxx xxxxxxx xxxxxxxxxx látek xxx xxxxxxxxxx xxxxxxxx

1x) xxxxxxxxxxx xxxxxxxx látka xxxxx xxxxxxx, xxxxxxxx kašli (xxxxxxxxxx xxxxx), tetanu, xxxxxx xxxxxxxx xxxxx (xxxxxxxxxxxx forma), virové xxxxxxxxxx X, xxxxxxx xxxxxxxxx Xxxxxxxxxxx xxxxxxxxxx xxx x (XXxXXxxXXXXXX):

Xxxxxxxxxxx xxxxxxxxxx1 xx méně xxx 30 xxxxxxxxxxxxx xxxxxxxx (IU)

Tetani xxxxxxxxxx1 xx xxxx xxx 40 xxxxxxxxxxxxx xxxxxxxx (XX)

Xxxxxxxx Xxxxxxxxxx pertussis:

Pertussis xxxxxxxxxx1 25 xxxxxxxxxx

Xxxxxxxxxxxxxxxx xxxxxxxxxxxx1 25 xxxxxxxxxx

Xxxxxxxxxxx1 8 xxxxxxxxxx

Xxxxxxxxx tegiminis xxxxxxxxxxx B2,3 10 xxxxxxxxxx

Xxxxx xxxxxxxxxxxxx (xxxxxxxxxxxx)

xxxxx 1 (xxxx Xxxxxxx)4 40 X jednotek xxxxxxxx

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

typus 3 (xxxx Xxxxxxx)4 32 X jednotek xxxxxxxx

Xxxxxxxxxxx xxxxxxxxxx xxxxx x xxxxxxxxxxxxxxx 10 xxxxxxxxxx

(xxxxxxxxxxxxxxxxxxx xxxxxxxx)3

xxxxxxxxx cum xxxxxx xxxxxxxxxx xxxx nosným xxxxxxxxx xxxxxxxxx 25 xxxxxxxxxx

XXXX

1xx) kombinovaná xxxxxxxx xxxxx proti xxxxxxx, xxxxxxxx xxxxx (acelulárni xxxxx), xxxxxx, xxxxxx xxxxxxxx xxxxx (inaktivovaná xxxxx), xxxxxx xxxxxxxxxx X, nákazám xxxxxxxxx Xxxxxxxxxxx xxxxxxxxxx typ x (XXxXXxxXXXXXX)

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

Xxxxxx xxxxxxxxxx ne xxxx xxx 40 xxxxxxxxxxxxx xxxxxxxx (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 jednotek xxxxxxxx4

xxxxx 3 (Xxxxxxx) 32 D jednotek xxxxxxxx4

Xxxxxxxxx tegiminis hepatitidy X5 10 xxxxxxxxxx

Xxxxxxxxxxx xxxxxxxxxx typu x 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 jednotek

Tetani xxxxxxxxxx&xxxx;≥ 40 xxxxxxxxxxxxx jednotek

Pertussis xxxxxxxxxx (PT) 25 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxxxxx (XXX) 25 mikrogramů

Pertactinum (69xX) 8 mikrogramů

NEBO

1ba) Xxxxxxxx xxxxx xxxxx xxxxxxx, tetanu x xxxxxxxx xxxxx (acelulární)

1 xxxxx (0,5 ml) xxxxxxxx:	Xxxxxxxxx 2 XX* (2 Xx)
Xxxxxxxxxxx xxxxxxxxxx
Xxxxxx xxxxxxxxxx	Xxxxxxxxx 20 XX* (5 Xx)
Xxxxxxxxx xxxxxxxx
Xxxxxxxxx xxxxxxxxxx	2,5 xxxxxxxxxx
Xxxxxxxxxxxxxx xxxxxxxxxxxx	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) Xxxxxxxx xxxxx xxxxx záškrtu, xxxxxx x xxxxxxxx xxxxx (acelulární xxxxxxxxxx) xx sníženým obsahem xxxxxxxx

Xxxxxxxxxxx anatoxinum1 ne xxxx než 2 xxxxxxxxxxx xxxxxxxx (IU) (2,5 Lf)

Tetani xxxxxxxxxx1 xx xxxx než 20 mezinárodních jednotek (XX) (5 Lf)

Bordetellae xxxxxxxxx antigena:

Pertussis xxxxxxxxxx1 8 mikrogramů

Pertussis xxxxxxxxxxxxxx xxxxxxxxxxxx1

8 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxx xxxxxxxx xxxxxxxxx1 2,5 xxxxxxxxxx

1 xxxxxxxxxxx na xxxxxxxxxxx hydroxid xxxxxxx (XX(XX)3) 0,3 miligramů XX3+ x fosforečnan xxxxxxx (AIPO4) 0,2 xxxxxxxxx AI3+

1c) xxxxxxxx xxxxx xxxxx xxxxxxx, xxxxxxxx xxxxx (acelulární xxxxx), xxxxxx, nákazám xxxxxxxxx Hemofilem xxxxxxxxxx x (DTaPHib):

Diphtheriae anatoxinum	min. 30 mezinárodních jednotek
Tetani xxxxxxxxxx	xxx. 40 mezinárodních xxxxxxxx
Xxxxxxxxx xxxxxxxxxx (XX)	25 xxxxxxxxxx
Xxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxxxxx (XXX)	25 xxxxxxxxxx
Xxxxxxxxxxx (69xX)	8 xxxxxxxxxx
Xxxxxxxxxxx xxxxxxxxxx X	10 xxxxxxxxxx
xxx anatoxino xxxxxxxx	20-40 xxxxxxxxxx

1x) xxxxxxxx xxxxx xxxxx xxxxxxx vyvolaným Xxxxxxxxxxx xxxxxxxxxx xxx x:

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

1x) xxxxxxxx látka xxxxx xxxxxx:

Xxxxxx anatoxinum ... xxx. 40 mezinárodních xxxxxxxx

1x) xxxxxxxx látka xxxxx xxxxxx hepatitidě X od 16 xxx x xxxx:

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx B ... 20 xxxxxxxxxx

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

Xxxxxxxxxxx virus xxxxxxxxxx (Xxxxxxx) xxx. 103,0 xxxxxxxx dávka xxx xxxxxxxx xxxxxxx₅₀

Xxxxxxxxxxx xxxxx xxxxxxxxxx (XXX 4385) xxx. 103,7 xxxxxxxx xxxxx xxx xxxxxxxx xxxxxxx₅₀

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

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

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

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

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

* nebo xxxxxxxx xxxxxxxxxxxxxx xxxxxxxx xxxxxxxxx xxxxxx xxxxxx xxxxxxxxxxxxx xxxxxx.

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

Xxxxxxxxxxxxxxx Streptococci xxxxxxxxxx typus:

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

1x) xxxxxxxx xxxxx xxxxxxxxxxx xxxxx xxxxxxxxxxxxx xxxxxxxx:

Xxxxxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 1

Xxxxxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 3

Pneumococcale xxxxxxxxxxxxxxx sérotypus 4

Pneumococcale xxxxxxxxxxxxxxx xxxxxxxxx 5

Xxxxxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 6A

Pneumococcale xxxxxxxxxxxxxxx xxxxxxxxx 6B

Pneumococcale xxxxxxxxxxxxxxx xxxxxxxxx 7F

Pneumococcale xxxxxxxxxxxxxxx xxxxxxxxx 9X

Xxxxxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 14

Pneumococcale xxxxxxxxxxxxxxx sérotypus 18X

Xxxxxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 19X

Xxxxxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 19X

Xxxxxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 23F

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

Diphtheriae xxxxxxxxxx	xx xxxx xxx 2 xxxxxxxxxxx xxxxxxxx
Xxxxxx anatoxinum	ne xxxx než 20 xxxxxxxxxxxxx xxxxxxxx

Xxxxxxxxx antigeny:

Pertussis xxxxxxxxxx	8 mikrogramů
Pertussis xxxxxxxxxxxxxx xxxxxxxxxxxx	8 mikrogramů
Pertaktin	2,5 mikrogramů

Virus xxxxxxxxxxxxxxx xxxxxxxxxxx:

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

XXXX

1xx) xxxxxxxx xxxxx proti záškrtu, xxxxxxxx kašli (xxxxxxxxxx xxxxx), xxxxxx, xxxxxx xxxxxxxx xxxxx (xxxxxxxxxxxx xxxxx):

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

Xxxxxxxxx antigeny:

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

-

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

1l) očkovací xxxxx proti tuberkulóze:

Mycobacterium xxxxx attenautum (XXX) xxxxxxx Xxxxxxx 1331.....0,75 xx

&xx;2,0 x 10⁶ ≤ 8,0 x 10⁶ XXX (živých xxxxxxx)

1x) xxxxxxxx látka xxxxx xxxxxx xxxxxxxxxx X xxx xxxxx xxxxxxxx do xxxxxxxxxxxx xxxxxxxx:

Xxxxxxxxx tegiminis xxxxxxxxxxx X biosyntheticum 20 xxxxxxxxxx; adjuvans AS04C xxxxxxxxxx 3-O-deacyl-4-monofosforyl-lipid X (XXX) 50 xxxxxxxxxx x 1 xxxxx

1x) Xxxxxxxx látka xxxxx xxxxxx xxxxxxxxxx X x dětské xxxxxxx:

Xxxxxxxxx xxxxxxxxx hepatitidis B 10 xxxxxxxxxx v 0,5 xx xxxxxxxx

2. Xxxxxxxxx složení xxxxxxxxxx xxxxx pro xxxxxxxx xxxxxxxx

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

Antigenum xxxxxxxxx xxxxxxxxxxx B ... 20 mikrogramů

2b) xxxxxxxx xxxxx xxxxx xxxxxxxxx

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

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

Hepatitis X xxxxx xxxxxxxxxxx

3. Xxxxxxxxx xxxxxxx očkovacích xxxxx xxx xxxxxxxxx xxxxxxxx

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

Xxxxxxxxx A xxxxx xxxxxxxxxxx

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

Xxxxx hepatitis X xxxxxxxxxxx

 

X xxxx 2016 s xxxxxxx xx xxxxxxxxxx xxxxxxxxxx xxxxxxxx č. 537/2006 Sb., x xxxxxxxx xxxxx xxxxxxxxx xxxxxxx, xx xxxxx xxxxxxxxxx xxxxxxxx, nelze xxxxxxxx xxxxxxxxx xxxxxx xxxxxxxxxxx složení xxxxxxxxxx xxxxx xxx pravidelná xxxxxxxx xxxxxxxxxxxx xxxxxx xxxxxxxxxxx xxxxxxx těchto xxxxxxxxxx látek xx Xxxxxx zákonů.

 

Ministr:

v z. XXXx. Policar x. x.

xxxxxxxx pro legislativu x xxxxx

Xxxxxxxxx

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

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

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

x xxxxxxxxx xx 10.5.2016

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