Plné znění - 390/2016 Sb.

Sdělení o antigenním složení očkovacích látek pro pravidelná, zvláštní a mimořádná očkování pro rok 2017

390/2016 Sb.

Sdělení Ministerstva zdravotnictví

INFORMACE

390

XXXXXXX

Xxxxxxxxxxxx xxxxxxxxxxxxx

xx xxx 28. xxxxxxxxx 2016

x xxxxxxxxxx xxxxxxx xxxxxxxxxx xxxxx xxx xxxxxxxxxx, xxxxxxxx x xxxxxxxxx xxxxxxxx pro xxx 2017

 

Xxxxxxxxxxxx xxxxxxxxxxxxx podle §80 odst. 1 xxxx. e) xxxxxx x. 258/2000 Xx., x xxxxxxx veřejného xxxxxx a x xxxxx některých xxxxxxxxxxxxx xxxxxx, xx znění xxxxxxxxxx xxxxxxxx, xxxxxxx xx xxxxxxx xxxxxxxxxx Xxxxxxx xxxxxxxxxx komise xxxxxxxxx xxxxxxx xxxxxxxxxx xxxxx xxx xxxxxxxxxx, xxxxxxxx x xxxxxxxxx xxxxxxxx xxx xxx 2017:

1. Antiqenní xxxxxxx xxxxxxxxxx látek pro xxxxxxxxxx očkování

1a) xxxxxxxxxxx xxxxxxxx xxxxx xxxxx xxxxxxx, xxxxxxxx xxxxx (xxxxxxxxxx xxxxx), tetanu, xxxxxx xxxxxxxx obrně (xxxxxxxxxxxx xxxxx), xxxxxx xxxxxxxxxx X, xxxxxxx xxxxxxxxx Xxxxxxxxxxx influenzae xxx x (DTaPHibVHBIPV):

Diphtheriae xxxxxxxxxx1 ne xxxx xxx 30 xxxxxxxxxxxxx xxxxxxxx (XX)

Xxxxxx anatoxinum1 xx xxxx než 40 xxxxxxxxxxxxx xxxxxxxx (XX)

Xxxxxxxx Xxxxxxxxxx pertussis:

Pertussis xxxxxxxxxx1 25 mikrogramů

Haemagglutininum xxxxxxxxxxxx1 25 xxxxxxxxxx

Xxxxxxxxxxx1 8 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx X2,3 10 xxxxxxxxxx

Xxxxx xxxxxxxxxxxxx (xxxxxxxxxxxx)

xxxxx 1 (kmen Xxxxxxx)4 40 X jednotek xxxxxxxx

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

xxxxx 3 (xxxx Xxxxxxx)4 32 X xxxxxxxx xxxxxxxx

Xxxxxxxxxxx xxxxxxxxxx xxxxx x xxxxxxxxxxxxxxx 10 xxxxxxxxxx

(xxxxxxxxxxxxxxxxxxx xxxxxxxx)3

xxxxxxxxx xxx tetani xxxxxxxxxx xxxx nosným xxxxxxxxx přibližně 25 xxxxxxxxxx

XXXX

1xx) kombinovaná xxxxxxxx xxxxx proti xxxxxxx, xxxxxxxx kašli (xxxxxxxxxx xxxxx), tetanu, xxxxxx xxxxxxxx xxxxx (xxxxxxxxxxxx xxxxx), virové xxxxxxxxxx X, xxxxxxx xxxxxxxxx Xxxxxxxxxxx xxxxxxxxxx xxx x (XXxXXxxXXXXXX)

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

Xxxxxx anatoxinum xx xxxx xxx 40 xxxxxxxxxxxxx jednotek (IU)2

Antigeny Xxxxxxxxxx xxxxxxxxx

Xxxxxxxxx xxxxxxxxxx 25 xxxxxxxxxx

Xxxxxxxxxxxxxx xxxxxxxxxxxx 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 D jednotek xxxxxxxx4

Xxxxxxxxx xxxxxxxxx hepatitidy X5 10 xxxxxxxxxx

Xxxxxxxxxxx xxxxxxxxxx xxxx x xxxxxxxxxxxxxxx 12 xxxxxxxxxx

(Xxxxxxxxxxxxxxxxxxx xxxxxxxx)

xxxxxxxxx xxx xxxxxx xxxxxxxxxx 22-36 mikrogramů

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

Xxxxxxxxxxx anatoxinum ³ 30 xxxxxxxxxxxxx xxxxxxxx

Xxxxxx xxxxxxxxxx ³ 40 xxxxxxxxxxxxx jednotek

Pertussis xxxxxxxxxx (XX) 25 mikrogramů

Pertussis xxxxxxxxxxxxxxx xxxxxxxxxxxx (XXX) 25 xxxxxxxxxx

Xxxxxxxxxxx (69xX) 8 mikrogramů

NEBO

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

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

XXXX

1xx) Očkovací xxxxx xxxxx xxxxxxx, xxxxxx a xxxxxxxx xxxxx (xxxxxxxxxx xxxxxxxxxx) xx xxxxxxxx xxxxxxx xxxxxxxx

Xxxxxxxxxxx xxxxxxxxxx1 xx xxxx než 2 xxxxxxxxxxx xxxxxxxx (XX) (2,5 Xx)

Xxxxxx anatoxinum1 xx méně xxx 20 mezinárodních xxxxxxxx (XX) (5 Xx)

Xxxxxxxxxxx xxxxxxxxx antigena:

Pertussis xxxxxxxxxx1 8 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxx xxxxxxxxxxxx1 8 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxx xxxxxxxx proteinum1 2,5 xxxxxxxxxx

1 xxxxxxxxxxx xx xxxxxxxxxxx xxxxxxxx xxxxxxx (AI(OH)3) 0,3 xxxxxxxxx XX3+

x xxxxxxxxxxx xxxxxxx (XXX04) 0,2 xxxxxxxxx XX3+

1x) xxxxxxxx xxxxx proti xxxxxxx, xxxxxxxx xxxxx (acelulární xxxxx), xxxxxx, xxxxxxx xxxxxxxxx Xxxxxxxxx xxxxxxxxxx x (XXxXXxx):

Xxxxxxxxxxx xxxxxxxxxx	xxx. 30 xxxxxxxxxxxxx xxxxxxxx
Xxxxxx xxxxxxxxxx	xxx. 40 xxxxxxxxxxxxx xxxxxxxx
Xxxxxxxxx anatoxinum (XX)	25 xxxxxxxxxx
Xxxxxxxxx haemaglutininum xxxxxxxxxxxx	(XXX) 25 mikrogramů
Pertactinum (69xX)	8 xxxxxxxxxx
Xxxxxxxxxxx xxxxxxxxxx B	10 xxxxxxxxxx
xxx xxxxxxxxx xxxxxxxx	20-40 xxxxxxxxxx

1x) xxxxxxxx xxxxx xxxxx nákazám vyvolaným Xxxxxxxxxxx influenzae typ x:

1 dávka xxxxxxxxxxxxx xxxxxxx obsahuje: Xxxxxxxxxxxxxxx Xxx xxxxxxxxxxx (10 xxxxxxxxxx) cum Anatoxino xxxxxxxx (přibližně 25 xxxxxxxxxx).

1x) xxxxxxxx látka xxxxx xxxxxx:

Xxxxxx xxxxxxxxxx … min. 40 xxxxxxxxxxxxx jednotek

1f) xxxxxxxx xxxxx xxxxx xxxxxx xxxxxxxxxx B xx 16 let x xxxx:

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx X

20 mikrogramů

1g) xxxxxxxx xxxxx proti virové xxxxxxxxxx X x xxxxxx xxxxxxx:

Xxxxxxxxx tegiminis xxxxxxxxxxx B

10 xxxxxxxxxx

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

Xxxxxxxxxxx xxxxx xxxxxxxxxx (Xxxxxxx) min. 10^3,0 xxxxxxxx dávka xxx xxxxxxxx kulturu₅₀ Xxxxxxxxxxx xxxxx xxxxxxxxxx (XXX 4385) xxx. 10^3,7 xxxxxxxx xxxxx xxx xxxxxxxx xxxxxxx₅₀ Xxxxxxxx xxxxx xxxxxxxxxx (Xxxxxx XX 27/3) xxx. 10^3,0 xxxxxxxx xxxxx xxx xxxxxxxx xxxxxxx₅₀

1xx) xxxxxxxx xxxxx xxxxx xxxxxx xxxxxxxx obrně x inaktivované xxxxx:

Xxxxx xxxxxxxxxxxxx xxxxxxxxxxx xxxxx 1 (Mahoney) … 40 xxxxxxxxxxx D xxxxxxxx*

Xxxxx xxxxxxxxxxxxx xxxxxxxxxxx xxxxx 2 (MEF-1) … 8 xxxxxxxxxxx X xxxxxxxx*

Xxxxx xxxxxxxxxxxxx xxxxxxxxxxx xxxxx 3 (Xxxxxxx) … 32 xxxxxxxxxxx D jednotek*

* xxxx xxxxxxxx ekvivalentních xxxxxxxx stanovené pomocí xxxxxx imunochemické xxxxxx.

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

Xxxxxxxxxxxxxxx Streptococci xxxxxxxxxx xxxxx:

1, 2, 3, 4, 5, 6X, 7X, 8, 9X, 9X, 10X, 11X, 12X, 14, 15X, 17X,

18X, 19X, 19F, 20, 22X, 23X, 33X … 25 xxxxxxxxxx x každého xxxxxxxx

1x) očkovací xxxxx xxxxxxxxxxx xxxxx xxxxxxxxxxxxx xxxxxxxx:

Xxxxxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 1

Xxxxxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 3

Xxxxxxxxxxxxx polysaccharidum xxxxxxxxx 4

Xxxxxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 5

Xxxxxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 6X

Xxxxxxxxxxxxx polysaccharidum sérotypus 6X

Xxxxxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 7X

Xxxxxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 9X

Xxxxxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 14

Xxxxxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 18X

Xxxxxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 19X

Xxxxxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 19X

Xxxxxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 23X

1x) očkovací xxxxx xxxxx xxxxxxx, xxxxxxxx xxxxx (xxxxxxxxxx xxxxx), xxxxxx, dětské xxxxxxxx xxxxx (inaktivovaná forma):

Xxxxxxxxxxx anatoxinum	ne méně xxx 2 mezinárodní xxxxxxxx
Xxxxxx xxxxxxxxxx	xx xxxx xxx 20 mezinárodních xxxxxxxx
Xxxxxxxxx antigeny:
Pertussis xxxxxxxxxx	8 xxxxxxxxxx
Xxxxxxxxx xxxxxxxxxxxxxx xxxxxxxxxxxx	8 xxxxxxxxxx
Xxxxxxxxx	2,5 xxxxxxxxxx
Xxxxx xxxxxxxxxxxxxxx xxxxxxxxxxx:
xxxxx 1 (kmen Xxxxxxx)	40 X jednotek xxxxxxxx
xxxxx 2 (kmen XXX-1)	8 X xxxxxxxx xxxxxxxx
xxxxx 3 (xxxx Xxxxxxx)	2 X jednotek xxxxxxxx

XXXX

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

Difterický xxxxxx	xxxx xxxx rovno 2 mezinárodní xxxxxxxx (2 Xx)
Xxxxxxxxx toxoid	více xxxx xxxxx 20 xxxxxxxxxxxxx xxxxxxxx (5 Xx)
Xxxxxxxxx antigeny:
Xxxxxxxxx xxxxxx	2,5 mikrogramu
Filamentózní xxxxxxxxxxxx	5 xxxxxxxxxx
&xxxx;&xxxx; Xxxxxxx xxxx 2+3	5 mikrogramů
Xxxxxxxxx	3 mikrogramy
Virus poliomyelitis xxxx 1 (inaktivovaný)	40 xxxxxxxxxxx X jednotek
Virus xxxxxxxxxxxxx xxxx 2 (xxxxxxxxxxxx)	8 antigenních X xxxxxxxx
Xxxxx poliomyelitis xxxx 3 (xxxxxxxxxxxx)	32 xxxxxxxxxxx X xxxxxxxx

1x) xxxxxxxx xxxxx xxxxx xxxxxxxxxxx (XXX vakcína)

1n) xxxxxxxx xxxxx xxxxx xxxxxx xxxxxxxxxx X pro xxxxx zařazené xx xxxxxxxxxxxx programu:

Antigenum xxxxxxxxx xxxxxxxxxxx X xxxxxxxxxxxxxx 20 xxxxxxxxxx; xxxxxxxx XX04X xxxxxxxxxx 3-X-xxxxxx-4-xxxxxxxxxxxx-xxxxx X (XXX) 50 xxxxxxxxxx x 1 xxxxx

2. Antigenní xxxxxxx xxxxxxxxxx xxxxx xxx xxxxxxxx xxxxxxxx

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

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx B

20 xxxxxxxxxx

2x) očkovací xxxxx xxxxx vzteklině

2c) xxxxxxxx xxxxx xxxxx xxxxxx xxxxxxxxxx A xx xxxxxxx pro xxxxxxx:

Xxxxxxxxx X xxxxx xxxxxxxxxxx

3. Xxxxxxxxx xxxxxxx xxxxxxxxxx xxxxx xxx xxxxxxxxx xxxxxxxx

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

Xxxxxxxxx A xxxxx xxxxxxxxxxx

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

Xxxxx xxxxxxxxx X xxxxxxxxxxx

X xxxx 2017 s xxxxxxx xx plánovanou xxxxxxxxxx xxxxxxxx č. 537/2006 Sb., x xxxxxxxx xxxxx xxxxxxxxx xxxxxxx, xx xxxxx xxxxxxxxxx xxxxxxxx, xxxxx xxxxxxxx xxxxxxxxx xxxxxx xxxxxxxxxxx složení xxxxxxxxxx xxxxx pro xxxxxxxxxx očkování xxxxxxxxxxxx xxxxxx xxxxxxxxxxx xxxxxxx xxxxxx očkovacích látek xx Xxxxxx xxxxxx.

 

Xxxxxxx:

XXXx. Xxxxxxx, XXX, v. x.

Xxxxxxxxx

Xxxxxx xxxxxxx č. 390/2016 Sb. xxxxx xxxxxxxxx dnem 17.12.2016.

Ke xxx xxxxxxxx právní xxxxxxx xxxxx měněn xx xxxxxxxxx.

Xxxxx jednotlivých xxxxxxxx norem xxxxxx xxxxxxxx xxxxxxxx x xxxxxxxx není aktualizováno, xxxxx xx jich xxxxxx derogační změna xxxxx xxxxxxxxx právního xxxxxxxx.