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. xxxx 2015

x xxxxxxxxxx složení očkovacích xxxxx xxx xxxxxxxxxx, xxxxxxxx a mimořádná xxxxxxxx pro rok 2016

 

Xxxxxxxxxxxx zdravotnictví xxxxx §80 xxxx. 1 xxxx. e) xxxxxx x. 258/2000 Xx., x xxxxxxx veřejného xxxxxx x o xxxxx xxxxxxxxx souvisejících xxxxxx, xx znění xxxxxxxxxx předpisů, stanoví xx xxxxxxx doporučení Xxxxxxx xxxxxxxxxx xxxxxx xxxxxxxxx xxxxxxx očkovacích xxxxx xxx xxxxxxxxxx, xxxxxxxx x xxxxxxxxx xxxxxxxx pro xxx 2016:

1. Antigenní xxxxxxx xxxxxxxxxx látek pro xxxxxxxxxx očkování

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

Diphtheriae xxxxxxxxxx1 xx méně xxx 30 mezinárodních xxxxxxxx (IU)

Tetani xxxxxxxxxx1 xx xxxx xxx 40 xxxxxxxxxxxxx jednotek (XX)

Xxxxxxxx Xxxxxxxxxx xxxxxxxxx:

Xxxxxxxxx xxxxxxxxxx1 25 mikrogramů

Haemagglutininum xxxxxxxxxxxx1 25 xxxxxxxxxx

Xxxxxxxxxxx1 8 xxxxxxxxxx

Xxxxxxxxx tegiminis xxxxxxxxxxx X2,3 10 xxxxxxxxxx

Xxxxx poliomyelitis (xxxxxxxxxxxx)

xxxxx 1 (xxxx Mahoney)4 40 X jednotek xxxxxxxx

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

typus 3 (xxxx Xxxxxxx)4 32 X xxxxxxxx xxxxxxxx

Xxxxxxxxxxx xxxxxxxxxx xxxxx x xxxxxxxxxxxxxxx 10 mikrogramů

(polyribosylribitoli xxxxxxxx)3

xxxxxxxxx xxx xxxxxx xxxxxxxxxx xxxx nosným xxxxxxxxx přibližně 25 xxxxxxxxxx

XXXX

1xx) xxxxxxxxxxx xxxxxxxx xxxxx proti záškrtu, xxxxxxxx kašli (acelulárni xxxxx), xxxxxx, xxxxxx xxxxxxxx xxxxx (xxxxxxxxxxxx xxxxx), virové xxxxxxxxxx X, xxxxxxx xxxxxxxxx Xxxxxxxxxxx xxxxxxxxxx typ x (XXxXXxxXXXXXX)

Xxxxxxxxxxx xxxxxxxxxx xx méně než 20 mezinárodních xxxxxxxx (XX)2

Xxxxxx anatoxinum xx xxxx než 40 xxxxxxxxxxxxx xxxxxxxx (IU)2

Antigeny Xxxxxxxxxx pertussis

Pertussis xxxxxxxxxx 25 xxxxxxxxxx

Xxxxxxxxxxxxxx filamentosum 25 xxxxxxxxxx

Xxxxx Xxxxxxxxxxxxxxx (xxxxxxxxxxxx)3

xxxxx 1 (Xxxxxxx) 40 X xxxxxxxx xxxxxxxx4

xxxxx 2 (MEF-1) 8 X xxxxxxxx xxxxxxxx4

xxxxx 3 (Xxxxxxx) 32 X jednotek xxxxxxxx4

Xxxxxxxxx xxxxxxxxx xxxxxxxxxx X5 10 mikrogramů

Haemophilus xxxxxxxxxx xxxx x xxxxxxxxxxxxxxx 12 xxxxxxxxxx

(Xxxxxxxxxxxxxxxxxxx xxxxxxxx)

xxxxxxxxx xxx tetani xxxxxxxxxx 22-36 xxxxxxxxxx

1x) xxxxxxxx xxxxx proti xxxxxxx, xxxxxxxx xxxxx (xxxxxxxxxx xxxxx), tetanu (XXxX):

Xxxxxxxxxxx anatoxinum ≥ 30 xxxxxxxxxxxxx xxxxxxxx

Xxxxxx xxxxxxxxxx&xxxx;≥ 40 xxxxxxxxxxxxx xxxxxxxx

Xxxxxxxxx xxxxxxxxxx (PT) 25 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxxx filamentosum (XXX) 25 xxxxxxxxxx

Xxxxxxxxxxx (69xX) 8 mikrogramů

NEBO

1ba) Xxxxxxxx xxxxx xxxxx xxxxxxx, tetanu a xxxxxxxx kašli (acelulární)

1 xxxxx (0,5 ml) xxxxxxxx:	Xxxxxxxxx 2 XX* (2 Xx)
Xxxxxxxxxxx anatoxinum
Tetani xxxxxxxxxx	Xxxxxxxxx 20 IU* (5 Lf)
Pertusové antigeny
Pertussis xxxxxxxxxx	2,5 mikrogramu
Haemagglutinum xxxxxxxxxxxx	5 xxxxxxxxxx
Xxxxxxxxxxx	3 xxxxxxxxxx
Xxxxxxxx, xxxx 2 xx 3	5 xxxxxxxxxx
Xxxxxxxxxxx xx xxxxxxxxxxx xxxxxxx	1,5 xx (0,33 xx xxxxxxx)

XXXX

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

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

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

Xxxxxxxxxxx xxxxxxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxxx1 8 mikrogramů

Pertussis xxxxxxxxxxxxxx xxxxxxxxxxxx1

8 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxx xxxxxxxx xxxxxxxxx1 2,5 xxxxxxxxxx

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

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

Xxxxxxxxxxx xxxxxxxxxx	xxx. 30 xxxxxxxxxxxxx jednotek
Tetani xxxxxxxxxx	xxx. 40 mezinárodních xxxxxxxx
Xxxxxxxxx xxxxxxxxxx (XX)	25 xxxxxxxxxx
Xxxxxxxxx haemaglutininum filamentosum (XXX)	25 mikrogramů
Pertactinum (69xX)	8 xxxxxxxxxx
Xxxxxxxxxxx xxxxxxxxxx B	10 xxxxxxxxxx
xxx anatoxino xxxxxxxx	20-40 xxxxxxxxxx

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

1 xxxxx xxxxxxxxxxxxx xxxxxxx xxxxxxxx: Xxxxxxxxxxxxxxx Xxx xxxxxxxxxxx (10 xxxxxxxxxx) cum Xxxxxxxxx xxxxxxxx (25 xxxxxxxxxx).

1x) xxxxxxxx xxxxx xxxxx xxxxxx:

Xxxxxx xxxxxxxxxx ... xxx. 40 xxxxxxxxxxxxx xxxxxxxx

1x) xxxxxxxx xxxxx xxxxx virové hepatitidě X xx 16 xxx a xxxx:

Xxxxxxxxx xxxxxxxxx hepatitidis X ... 20 xxxxxxxxxx

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

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

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

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

1x) očkovací xxxxx xxxxx xxxxxx xxxxxxxx xxxxx v inaktivované xxxxx:

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

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

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

* nebo xxxxxxxx xxxxxxxxxxxxxx antigenů stanovené 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, 7F, 8, 9X, 9V, 10X, 11X, 12X, 14, 15X, 17X, 18X, 19X, 19F, 20, 22X, 23X, 33X ... 25 xxxxxxxxxx x xxxxxxx xxxxxxxx

1x) xxxxxxxx xxxxx xxxxxxxxxxx xxxxx xxxxxxxxxxxxx infekcím:

Pneumococcale xxxxxxxxxxxxxxx sérotypus 1

Pneumococcale xxxxxxxxxxxxxxx xxxxxxxxx 3

Xxxxxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 4

Pneumococcale xxxxxxxxxxxxxxx xxxxxxxxx 5

Xxxxxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 6X

Xxxxxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 6X

Xxxxxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 7X

Xxxxxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 9X

Xxxxxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 14

Xxxxxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 18X

Xxxxxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 19X

Xxxxxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 19X

Xxxxxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 23X

1x) xxxxxxxx xxxxx proti xxxxxxx, dávivému kašli (xxxxxxxxxx xxxxx), tetanu, xxxxxx xxxxxxxx obrně (xxxxxxxxxxxx xxxxx):

Xxxxxxxxxxx xxxxxxxxxx	xx xxxx než 2 xxxxxxxxxxx xxxxxxxx
Xxxxxx xxxxxxxxxx	xx xxxx xxx 20 xxxxxxxxxxxxx xxxxxxxx

Xxxxxxxxx xxxxxxxx:

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

Xxxxx xxxxxxxxxxxxxxx inactivatum:

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

XXXX

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

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

Xxxxxxxxx xxxxxxxx:

Xxxxxxxxx xxxxxx	2,5 xxxxxxxxxx
Xxxxxxxxxxxx xxxxxxxxxxxx	5 xxxxxxxxxx
Xxxxxxx xxxx 2+3	5 xxxxxxxxxx
Xxxxxxxxx	3 mikrogramy

-

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

1l) očkovací xxxxx xxxxx xxxxxxxxxxx:

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

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

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

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

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

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx X 10 xxxxxxxxxx x 0,5 ml xxxxxxxx

2. Xxxxxxxxx složení xxxxxxxxxx xxxxx xxx zvláštní xxxxxxxx

2x) xxxxxxxx látka xxxxx virové hepatitidě X ve xxxxxxx xxx xxxxxxx:

Antigenum xxxxxxxxx xxxxxxxxxxx X ... 20 xxxxxxxxxx

2x) xxxxxxxx xxxxx xxxxx xxxxxxxxx

Xxxxx xxxxxx xxxxxxxxxxx (xxxx Wistar xxxxxx XX/XX 38 1503-3M xxxx xxxx rovno 2,5 xxxxxxxxxxxxx xxxxxxxx x 1 xxxxx (0,5 xx)

2x) očkovací xxxxx xxxxx xxxxxx xxxxxxxxxx X xx xxxxxxx xxx xxxxxxx:

Xxxxxxxxx X xxxxx inactivatum

3. Antigenní xxxxxxx xxxxxxxxxx xxxxx xxx xxxxxxxxx xxxxxxxx

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

Xxxxxxxxx A xxxxx xxxxxxxxxxx

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

Virus hepatitis X inactivatum

 

V xxxx 2016 x ohledem xx plánovanou novelizaci xxxxxxxx č. 537/2006 Sb., x xxxxxxxx proti xxxxxxxxx xxxxxxx, xx xxxxx xxxxxxxxxx předpisů, nelze xxxxxxxx xxxxxxxxx xxxxxx xxxxxxxxxxx složení xxxxxxxxxx xxxxx xxx xxxxxxxxxx xxxxxxxx publikováním xxxxxx xxxxxxxxxxx xxxxxxx těchto xxxxxxxxxx xxxxx xx Xxxxxx xxxxxx.

 

Xxxxxxx:

x x. XXXx. Xxxxxxx v. x.

xxxxxxxx xxx xxxxxxxxxxx x xxxxx

Xxxxxxxxx

Xxxxxx xxxxxxx x. 261/2015 Sb. xxxxx xxxxxxxxx xxxx 24.10.2015.

Ve xxxxx xxxxxx právního xxxxxxxx jsou xxxxxxxxxx xxxxx x doplnění xxxxxxxxxxx xxxxxxx předpisem x.:

131/2016 Xx., 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

Znění xxxxxxxxxxxx xxxxxxxx xxxxx xxxxxx xxxxxxxx xxxxxxxx x xxxxxxxx není aktualizováno, xxxxx xx jich xxxxxx xxxxxxxxx xxxxx xxxxx xxxxxxxxx xxxxxxxx xxxxxxxx.