Právní předpis byl sestaven k datu 29.12.2023.
Zobrazené znění právního předpisu je účinné od 29.12.2023.
Sdělení Ministerstva zdravotnictví o antigenním složení očkovacích látek pro pravidelná, zvláštní a mimořádná očkování pro rok 2024
420/2023 Sb.
420
XXXXXXX
Xxxxxxxxxxxx xxxxxxxxxxxxx
xx dne 19. xxxxxxxx 2023
x xxxxxxxxxx xxxxxxx očkovacích xxxxx xxx xxxxxxxxxx, xxxxxxxx x xxxxxxxxx xxxxxxxx pro xxx 2024
&xxxx;
Xxxxxxxxxxxx zdravotnictví xxxxx §80 odst. 1 xxxx. x) xxxxxx x. 258/2000 Xx., x xxxxxxx veřejného xxxxxx a x xxxxx některých xxxxxxxxxxxxx xxxxxx, xx znění xxxxxxxxxx xxxxxxxx, xxxxxxx xx základě doporučení Xxxxxxx xxxxxxxxxx xxxxxx xxxxxxxxx xxxxxxx xxxxxxxxxx xxxxx pro xxxxxxxxxx, xxxxxxxx x xxxxxxxxx xxxxxxxx pro xxx 2024:
1.&xxxx;Xxxxxxxxx xxxxxxx xxxxxxxxxx xxxxx pro xxxxxxxxxx xxxxxxxx
1x)&xxxx;xxxxxxxxxxx xxxxxxxx xxxxx xxxxx xxxxxxx, dávivému xxxxx (xxxxxxxxxx forma), xxxxxx, xxxxxx xxxxxxxx xxxxx (xxxxxxxxxxxx forma), xxxxxx hepatitidě B, xxxxxxx xxxxxxxxx Xxxxxxxxxxx xxxxxxxxxx xxx x (XXxXXxxXXXXXX)
Xx xxxxxxxxxxxx 1 xxxxx (0,5 xx) xxxxxxxx:
Xxxxxxxxxxx xxxxxxxxxx1&xxxx;xx xxxx xxx 30 xxxxxxxxxxxxx xxxxxxxx (XX)
Xxxxxx anatoxinum1 ne xxxx než 40 xxxxxxxxxxxxx xxxxxxxx (XX)
Xxxxxxxx Xxxxxxxxxx pertussis:
Pertussis xxxxxxxxxx (XX)1&xxxx;25 xxxxxxxxxx
Xxxxxxxxx xxxxxxxxxxxxxxxx xxxxxxxxxxxx (XXX)1&xxxx;25 xxxxxxxxxx
Xxxxxxxxxxx (XXX)1&xxxx;8 mikrogramů
Antigenum tegiminis xxxxxxxxxxx X (HBs)2,3 10 xxxxxxxxxx
Xxxxx xxxxxxxxxxxxxxx xxxxxxxxxxx (XXX)
xx xxx 1 (xxxx Xxxxxxx)4&xxxx;40 D xxxxxxxx xxxxxxxx
xxxxx 2 (xxxx XXX-1)4&xxxx;8 X xxxxxxxx antigenu
typus 3 (xxxx Xxxxxxx)4&xxxx;32 X xxxxxxxx xxxxxxxx
Xxxxxxxxxxx xxxxxxxxxx xxxxx b xxxxxxxxxxxxxxx
(Xxxxxxxxxxxxxxxxxxx xxxxxxxx) 10 xxxxxxxxxx
xxxx. xxx xxxxxx. xxxxxxxx xxxx xxxxx protein xxxxxxxxx 25 xxxxxxxxxx
1&xxxx;xxxxxxxxxxx xx xxxxxxxx xxxxxxx, xxxxxxxxxxx (Xx(XX)3) 0,5 xxxxxxxxx Xx3+
2&xxxx;xxxxxxxx xxxxxxxxxxxxx XXX technologií na xxxxxxx xxxxxxxxxxxx xxxxx (Xxxxxxxxxxxxx cerevisiae)
3 adsorbováno xx xxxxxxxxxxx hlinitý (AlPO4) 0,32 miligramů Xx3+
4&xxxx;xxxxxxxxx xx VERO xxxxxxx
XXXX
1xx)&xxxx;xxxxxxxxxxx xxxxxxxx xxxxx xxxxx xxxxxxx, xxxxxxxx kašli (xxxxxxxxxx xxxxx), xxxxxx, xxxxxx xxxxxxxx xxxxx (xxxxxxxxxxxx forma), xxxxxx xxxxxxxxxx X, nákazám xxxxxxxxx Xxxxxxxxxxx influenzae xxx x (XXxXXxxXXXXXX)
Xxxxx xxxxx1&xxxx;(0,5 xx) xxxxxxxx:
Xxxxxxxxxxx xxxxxxxxxx xx méně xxx 20 xxxxxxxxxxxxx xxxxxxxx (XX)2
Xxxxxx anatoxinum xx xxxx xxx 40 mezinárodních jednotek (XX)2
Xxxxxxxx Xxxxxxxxxx xxxxxxxxx
Xxxxxxxxx xxxxxxxxxx 25 xxxxxxxxxx
Xxxxxxxxxxxxxx xxxxxxxxxxxx 25 xxxxxxxxxx
Xxxxx Xxxxxxxxxxxxxxx (inaktivovaný)3
typus 1 (Xxxxxxx) 40 X xxxxxxxx xxxxxxxx4
xx xxx 2 (MEF-1) 8 X xxxxxxxx xxxxxxxx4
xxxxx 3 (Xxxxxxx) 32 X xxxxxxxx xxxxxxxx4
Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx X5&xxxx;10 xxxxxxxxxx
Xxxxxxxxxxxxxxxxxxx xxxxxxxx haemophili xxxxxxxxxx X 12 xxxxxxxxxx
(Xxxxxxxxxxxxxxxxxxx phosphas)
conjugata xxx xxxxxx xxxxxxxxxx 22-36 xxxxxxxxxx
1&xxxx;xxxxxxxxxxx xx xxxxxxxxxxx xxxxxxxx hlinitý (0,6 xx Xx3+)
2&xxxx;xxxx xxxxxx xxx xxxxxxxxxxxxx (x = 0,95)
3&xxxx;xxxxxxxxx na XXXX xxxxxxx
4&xxxx;xxxx xxxxxxxxxxxx xxxxxxxx xxxxxxxx xxxxxxxxx xxxxxxx imunochemickou xxxxxxx
5&xxxx;xxxxxxxx xxxxxxxxxxxxx XXX xxxxxxxxxxx x xxxxxxxxxxxx xxxxxxx Xxxxxxxxx xxxxxxxxxx
XXXX
1xx)&xxxx;Xxxxxxx proti xxxxxxx, tetanu, xxxxxxxx xxxxx (xxxxxxxxxx komponenta), xxxxxxxxxx X (xXXX), xxxxxx xxxxxxxx xxxxx (xxxxxxxxxxxx) a konjugovaná xxxxxxx xxxxx Xxxxxxxxxxx xxxx x (xxxxxxxxxxx)
Xxxxx xxxxx (0,5 xx) xxxxxxxx:
Xxxxxxxxxxx anatoxinum1 ne xxxx xxx 20 IU
Tetani xxxxxxxxxx1&xxxx;xx xxxx xxx 40 XX
Xxxxxxxx Xxxxxxxxxxx xxxxxxxx1
Xxxxxxxxx xxxxxxxxxx (PT) 20 xxxxxxxxxx
Xxxxxxxxxxxxxxx xxxxxxxxxxxx (XXX) 20 mikrogramů
Pertactinum (XXX) 3 xxxxxxxxxx
Xxxxxxxx xxxx 2 xx 3 (XXX) 5 xxxxxxxxxx
Xxxxxxxxx tegiminis hepatitidis X&xxxx;2,3&xxxx;10 xxxxxxxxxx
Xxxxx xxxxxxxxxxxxxxx (xxxxxxxxxxx)4
Xxxxx 1 (Mahoney) 40 X xxxxxxxx xxxxxxxx5
Xxxxx 2 (XXX-1) 8 X xxxxxxxx xxxxxxxx5
Xxxxx 3 (Xxxxxxx) 32 D xxxxxxxx xxxxxxxx5
Xxxxxxxxxxxxxx Xxxxxxxxxx influenzae xxxxx b
(Polyribosylribitoli xxxxxxxx) 3 mikrogramy xxxxxxxxxx xxx xxxxxxxxx meningococci xxxxx x2&xxxx;50 mikrogramů
1 adsorbováno xx xxxxxxxxxxx xxxxxxx (0,17 mg Al3+)
2 adsorbováno xx xxxxxxxxxxx hydroxid xxxxxxx xxxxxx (0,15 xx Xx3+)
3&xxxx;xxxxxxxx rekombinantní XXX xxxxxxxxxxx v xxxxxxxxxxxx xxxxxxx Xxxxxxxxxxxxx xxxxxxxxxx
4&xxxx;xxxxxxxxx xx Xxxx xxxxxxx
5&xxxx;xxxx ekvivalentní xxxxxxxx xxxxxxxx xxxxxxxxx xxxxxxx xxxxxxxxxxxxxx xxxxxxx.
1x)&xxxx;xxxxxxxx xxxxx xxxxx xxxxxxx, xxxxxxxx xxxxx (xxxxxxxxxx forma), xxxxxx (DTaP)
Jedna xxxxx (0,5 xx) obsahuje xxxx xxxxxx látky:
Diphtheriae xxxxxxxxxx* ≥ 30 XX
Xxxxxx xxxxxxxxxx* ≥ 40 XX
Xxxxxxxxx xxxxxxxxxx* (XX) 25 xxxxxxxxxx
Xxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxxxxx* (XXX) 25 xxxxxxxxxx
Xxxxxxxxxxx* (69kD) 8 mikrogramů
* adsorbováno xx xxxxxxxx xxxxxxx celkem: 0,5 miligramů
NEBO
1ba) Očkovací xxxxx xxxxx záškrtu, xxxxxx x dávivému xxxxx (xxxxxxxxxx) xx sníženým xxxxxxx antigenů (Tdap)
Jedna xxxxx (0,5 xx) xxxxxxxx:
Xxxxxxxxxxx xxxxxxxxxx - Xxxxxxxxx 2 XX* (2 Xx)
Xxxxxx xxxxxxxxxx - Xxxxxxxxx 20 XX* (5 Xx)
Xxxxxxxxx xxxxxxxx
Xxxxxxxxx xxxxxxxxxx - 2,5 mikrogramu
Haemagglutinum xxxxxxxxxxxx - 5 mikrogramu
Pertactinum - 3 xxxxxxxxxx
Xxxxxxxx, xxxx 2 xx 3 - 5 xxxxxxxxxx
Xxxxxxxxxxx xx fosforečnan xxxxxxx - 1,5 xx (0,33 mg xxxxxxx)
*&xxxx;Xxxx xxxxxx xxxxxxx xxxxxxxxx spolehlivosti (x = 0,95) xxxxxxxx xxxxxx xxxxx testu xxxxxxxxx v Xxxxxxxxx xxxxxxxx.
XXXX
1xx)&xxxx;Xxxxxxxx xxxxx xxxxx xxxxxxx, xxxxxx a xxxxxxxx kašli (xxxxxxxxxx xxxxxxxxxx) se sníženým xxxxxxx antigenů (Xxxx)
Xxxxx xxxxx (0,5 xx) xxxxxxxx:
Xxxxxxxxxxx anatoxinum1 ne méně xxx 2 xxxxxxxxxxx xxxxxxxx (XX) (2,5 Xx)
Xxxxxx anatoxinum1 ne méně xxx 20 mezinárodních xxxxxxxx (XX) (5 Xx)
Xxxxxxxxxxx pertussis antigena:
Pertussis xxxxxxxxxx1&xxxx;8 xxxxxxxxxx
Xxxxxxxxx xxxxxxxxxxxxxx xxxxxxxxxxxx1&xxxx;8 mikrogramu
Pertussis xxxxxxxxx xxxxxxxx xxxxxxxxx1&xxxx;2,5 xxxxxxxxxx
1&xxxx;xxxxxxxxxxx xx xxxxxxxxxxx xxxxxxxx xxxxxxx (Xx(XX)3) 0,3 xxxxxxxxx Al3+ a xxxxxxxxxxx xxxxxxx (XXXX4) 0,2 xxxxxxxxx Xx3+
1x)&xxxx;xxxxxxxx látka xxxxx xxxxxxx xxxxxxxxx Xxxxxxxxxxx xxxxxxxxxx xxx x:
Xxxxx xxxxx xxxxxxxxxxxxx xxxxxxx obsahuje:
Polysaccharidum Hib xxxxxxxxxxx (10 mikrogramu) xxx Xxxxxxxxx xxxxxxxx (xxxxxxxxx 25 xxxxxxxxxx).
1x)&xxxx;xxxxxxxx xxxxx proti xxxxxx:
Xxxxx xxxxx xxxxxxxx:
Xxxxxx xxxxxxxxxx - xxx. 40 xxxxxxxxxxxxx xxxxxxxx
1x)&xxxx;xxxxxxxx xxxxx xxxxx xxxxxx xxxxxxxxxx X v xxxxxx xxxxxxx:
Xxxxx dávka obsahuje:
Antigenum xxxxxxxxx xxxxxxxxxxx X - 10 xxxxxxxxxx
1x)&xxxx;xxxxxxxx xxxxx proti xxxxxx xxxxxxxxxx B x xxxxxxx xxxxxxx
Xxxxx dávka xxxxxxxx:
Xxxxxxxxx tegiminis xxxxxxxxxxx X - 20 xxxxxxxxxx
1x)&xxxx;xxxxxxxx látka proti xxxxxxxxxx, xxxxxxxxxx x xxxxxxxxx:
Xxxxx xxxxx xxxxxxxx:
Xxxxxxxxxxx xxxxx attenuatum1 (Schwarz) xxx. 103,0&xxxx;xxxxxxxx xxxxx xxx xxxxxxxx xxxxxxx503
Xxxxxxxxxxx virus xxxxxxxxxx1&xxxx;(XXX 4385) min. 103,7&xxxx;xxxxxxxx xxxxx pro xxxxxxxx kulturu503
Rubeolae xxxxx xxxxxxxxxx2&xxxx;(Xxxxxx XX 27/3) xxx. 103,0&xxxx;xxxxxxxx xxxxx xxx xxxxxxxx kulturu503
1 pomnoženo xx xxxxxxx xxxxxxxx xxxxxx
2&xxxx;xxxxxxxxx xx xxxxxxxx xxxxxxxxxxx xxxxxxx (XXX-5)
3&xxxx;50% xxxxxxxx dávka xxxxxxx xxxxxxx
XXXX
1xx)&xxxx;xxxxxxxx xxxxx xxxxx xxxxxxxxxx, xxxxxxxxxx a xxxxxxxxx
Xx xxxxxxxxxx obsahuje xxxxx xxxxx (0,5 xx):
Xxxxx xxxxxxxxxxx1&xxxx;xxxxx xxxxxxxxxx (xxxx Enders’ Edmonston) xx xxxx než 1x103&xxxx;XXXX50*
Xxxxx xxxxxxxxxxx1&xxxx;xxxxx xxxxxxxxxx (xxxx Jeryl Xxxx™, xxxxxxx X) xx xxxx než 12,5x103&xxxx;XXXX50*
Xxxxx xxxxxxxx2&xxxx;xxxxx xxxxxxxxxx (kmen Xxxxxx XX 27/3) xx xxxx než 1x103&xxxx;XXXX50*
*&xxxx;50% infekční xxxxx xxxxxxx xxxxxxx
1&xxxx;xxxxxxxx xx xxxxxxx kuřecích embryí.
2 vyrobeno xx xxxxxxxx xxxxxxxxxxx xxxxxxxx XX-38 xxxxxxxxxxxxx.
1x)&xxxx;xxxxxxxx xxxxx xxxxx xxxxxx xxxxxxxx xxxxx x xxxxxxxxxxxx xxxxx:
Xxxxx dávka xxxxxxxx:
Xxxxx xxxxxxxxxxxxx xxxxxxxxxxx xxxxx 1 (Mahoney) ..... 40 antigenních X jednotek*
Virus poliomyelitis xxxxxxxxxxx xxxxx 2 (XXX-1) .......... 8 xxxxxxxxxxx X xxxxxxxx*
Xxxxx xxxxxxxxxxxxx xxxxxxxxxxx typus 3 (Saukett) ........ 32 xxxxxxxxxxx X xxxxxxxx*
*&xxxx;xxxx xxxxxxxx xxxxxxxxxxxxxx xxxxxxxx xxxxxxxxx xxxxxx xxxxxx xxxxxxxxxxxxx xxxxxx.
1xx)&xxxx;xxxxxxxx xxxxx xxxxx xxxxxxxxxxxxx xxxxxxxx používané x xxxxxxxxxx xxxxxxxx:
1xxx)&xxxx;xxxxxxxxxxx očkovací xxxxx obsahuje:
Streptococci xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 1x&xxxx;2,2 μx
Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 31 2,2 μg
Streptococci xxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 41&xxxx;2,2 μx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 51 2,2 μx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 6X1&xxxx;2,2 μg
Streptococci xxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 6X1&xxxx;4,4 μx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 7X1&xxxx;2,2 μx
Xxxxxxxxxxxx xxxxxxxxxx polysaecharidum xxxxxxxxx 9X1&xxxx;2,2 μg
Streptococci xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 141&xxxx;2,2 μx
Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 18X1&xxxx;2,2 μx
Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 19X1&xxxx;2,2 μx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 19X1&xxxx;2,2 μx
Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 23X1&xxxx;2,2 μx
1 Xxxxxxxxxx x xxxxxx xxxxxxxxx XXX197 x xxxxxxxxxx na xxxxxxxxxxx xxxxxxx (0,125 xx xxxxxxx).
X
1xxx)&xxxx;xxxxx xxxxxxxxxxxxx xxxxxxxx
xx 25 mikrogramech xxxxxxxxxxxxx 23 xxxxxxxxxxxxxx xxxxxxxxxxxxxxxxx xxxxxxxx: 1, 2, 3, 4, 5, 6B, 7X, 8, 9X, 9X, 10X, 11A, 12F, 14, 15B, 17X, 18X, 19X, 19X, 20, 22X, 23X, 33X.
XXXX
1xxx)&xxxx;xxxxxxxxxxx očkovací xxxxx xxxxx xxxxxxxxxxxxx xxxxxxxx
Xxxxx xxxxx (0,5 xx) xxxxxxxx:
Xxxxxxxxxxxx bakterie (xxxxxxxxxx) Xxxxxxxxxxxxx pneumoniae xxxxxxxx 1&xxxx;1,2&xxxx;2,2 μx
xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 3&xxxx;1,2&xxxx;2,2 μx
xxxxxxxxxxxx xxxxxxxx (pneumokoka) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 4 1,2 2,2 μx
xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx pneumoniae xxxxxxxx 5&xxxx;1,2&xxxx;2,2 μx
xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 6X&xxxx;1,2&xxxx;2,2 μx
xxxxxxxxxxxx xxxxxxxx (pneumokoka) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 6X&xxxx;1,2&xxxx;4,4 μx
xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx sérotypu 7X&xxxx;1,2&xxxx;2,2 μx
xxxxxxxxxxxx bakterie (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 8&xxxx;1,2&xxxx;2,2 μx
xxxxxxxxxxxx xxxxxxxx (pneumokoka) Xxxxxxxxxxxxx xxxxxxxxxx sérotypu 9X&xxxx;1,2&xxxx;2,2 μx
xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 10X&xxxx;1,2&xxxx;2,2 μx
xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Streptococcus pneumoniae xxxxxxxx 11X&xxxx;1,2&xxxx;2,2 μx
xxxxxxxxxxxx xxxxxxxx (pneumokoka) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 12F 1,2 2,2 μx
xxxxxxxxxxxx xxxxxxxx (pneumokoka) Xxxxxxxxxxxxx xxxxxxxxxx sérotypu 14&xxxx;1,2&xxxx;2,2 μg
polysacharid xxxxxxxx (xxxxxxxxxx) Streptococcus xxxxxxxxxx xxxxxxxx 15X&xxxx;1,2&xxxx;2,2 μx
xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Streptococcus xxxxxxxxxx xxxxxxxx 18X&xxxx;1,2&xxxx;2,2 μx
xxxxxxxxxxxx bakterie (xxxxxxxxxx) Xxxxxxxxxxxxx pneumoniae xxxxxxxx 19X&xxxx;1,2&xxxx;2,2 μg
polysacharid xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 19X&xxxx;1,2&xxxx;2,2 μg
polysacharid xxxxxxxx (xxxxxxxxxx) Streptococcus xxxxxxxxxx xxxxxxxx 22X&xxxx;1,2&xxxx;2,2 μx
xxxxxxxxxxxx bakterie (pneumokoka) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 23X&xxxx;1,2&xxxx;2,2 μg
polysacharid bakterie (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 33F 1,2 2,2 μx
1 Xxxxxxxxxx x nosným xxxxxxxxx XXX197&xxxx;(xxxxxxxxx 51 μx xx dávku)
2 Xxxxxxxxxx na xxxxxxxxxxx xxxxxxx (0,125 mg xxxxxxx xx xxxxx)
1x)&xxxx;xxxxxxxx xxxxx proti xxxxxxx, xxxxxxxx xxxxx (xxxxxxxxxx xxxxx), xxxxxx, xxxxxx xxxxxxxx xxxxx (xxxxxxxxxxxx xxxxx):
Xxxxx xxxxx (0,5 xx) xxxxxxxx:
Xxxxxxxxxxx anatoxinum1 - xx méně než 2 xxxxxxxxxxx xxxxxxxx (XX) (2,5 Xx)
Xxxxxx xxxxxxxxxx1&xxxx;- xx xxxx xxx 20 xxxxxxxxxxxxx xxxxxxxx (XX) (5 Xx)
Xxxxxxxxxxx xxxxxxxxx antigena:
Pertussis xxxxxxxxxx1-&xxxx;8 xxxxxxxxxx
Xxxxxxxxx xxxxxxxxxxxxxx xxxxxxxxxxxx1&xxxx;- 8 xxxxxxxxxx
Xxxxxxxxx1&xxxx;2,5 xxxxxxxxxx
Xxxxx poliomyelitidis inactivatum:
ty xxx 1 (kmen Xxxxxxx)2&xxxx;- 40 X xxxxxxxx antigenu
typus 2 (xxxx MEF-1)2 - 8 X jednotek antigenu
typus 3 (xxxx Xxxxxxx)2&xxxx;- 32 D xxxxxxxx xxxxxxxx
1 xxxxxxxxxxx na xxxxxxxxxxx xxxxxxxx xxxxxxx (Xx(XX)3) 0,3 xxxxxxxxx Xx3+&xxxx;x xxxxxxxxxxx hlinitý (XxXX4) 0,2 xxxxxxxxx Xx3+
2 xxxxxxxxx na XXXX xxxxxxx
XXXX
1xx)&xxxx;xxxxxxxx xxxxx xxxxx xxxxxxx, xxxxxxxx xxxxx (xxxxxxxxxx xxxxx), xxxxxx, dětské přenosné xxxxx (xxxxxxxxxxxx xxxxx):
Xxxxx xxxxx (0,5 ml) xxxxxxxx:
Xxxxxxxxxxx xxxxxxxxxx xxxxxxxxx 2 XX* (2,5 Xx)
Xxxxxx anatoxinum xxxxxxxxx 20 XX* (5 Xx)
Xxxxxxxxx antigeny:
Pertussis anatoxinum 2,5 xxxxxxxxxx
Xxxxxxxxx xxxxxxxxxxxxxxxx xxxxxxxxxxxx 5 xxxxxxxxxx
Xxxxxxxxxxx 3 mikrogramy
Fimbriae, xxxx 2 xx 3 5 xxxxxxxxxx
Xxxxx xxxxxxxxxxxxxxx (xxxxxxxxxxx)**
xxxxx 1 40 X jednotek xxxxxxxx
xx xxx 2 8 X xxxxxxxx antigenu
typus 3 32 D xxxxxxxx antigenu
Adsorbováno xx xxxxxxxxxxx hlinitý 1,5 xx (0,33 xx xxxxxxx)
*&xxxx;Xxxx spodní hranice xxxxxxxxx xxxxxxxxxxxxx (x = 0,95) xxxxxxxx xxxxxx xxxxx xxxxx xxxxxxxxx x Xxxxxxxxx xxxxxxxx.
**&xxxx;Xxxxxxxxxxx xx Vero xxxxxxx.
1x)&xxxx;xxxxxxxx xxxxx xxxxx xxxxxxxxxxx (BCG vakcína)
1k) očkovací xxxxx xxxxx xxxxxx xxxxxxxxxx B xxx xxxxx xxxxxxxx xx xxxxxxxxxxxx xxxxxxxx:
Xxxxx dávka (0,5 ml) vakcíny xxxxxxxx:
Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx X1,2,3&xxxx;- 20 xxxxxxxxxx
1 xxxxxxxxxx xx XX04X xxxxxxxxxx: - 3-X-xxxxxx-4'-xxxxxxxxxxxx-xxxxx X (MPL)2 50 xxxxxxxxxx
2 xxxxxxxxxxx xx fosforečnan xxxxxxx (xxxxxx 0,5 xxxxxxxxx Xx3+)
3 xxxxxxxx xx xxxxxxx kvasinkových xxxxx (Xxxxxxxxxxxxx cerevisiae) xxxxxxxxxxxxx XXX xxxxxxxxxxx.
2.&xxxx;Xxxxxxxxx xxxxxxx očkovacích xxxxx xxx xxxxxxxx xxxxxxxx
2x)&xxxx;xxxxxxxx xxxxx xxxxx xxxxxx xxxxxxxxxx X xx xxxxxxx xxx xxxxxxx:
Xxxxx xxxxx obsahuje:
Antigenum xxxxxxxxx xxxxxxxxxxx X - 20 mikrogramů
2b) očkovací látka xxxxx vzteklině
2c) očkovací látka xxxxx virové xxxxxxxxxx X xx xxxxxxx xxx dospělé:
Jedna xxxxx xxxxxxxx:
Xxxxxxxxx A virus xxxxxxxxxxx
2x)&xxxx;xxxxxxxx látka xxxxx xxxxxxxxxx, xxxxxxxxxx a xxxxxxxxx:
Xxxxx dávka xxxxxxxx:
Xxxxxxxxxxx xxxxx xxxxxxxxxx1&xxxx;(Xxxxxxx) xxx. 103,0&xxxx;xxxxxxxx xxxxx xxx xxxxxxxx kulturu503
Parotitidis xxxxx xxxxxxxxxx1&xxxx;(XXX 4385) min. 103,7&xxxx;xxxxxxxx dávka xxx xxxxxxxx xxxxxxx503
Xxxxxxxx xxxxx xxxxxxxxxx2&xxxx;(Xxxxxx XX 27/3) xxx. 103,0&xxxx;xxxxxxxx xxxxx xxx xxxxxxxx xxxxxxx503
1&xxxx;xxxxxxxxx xx xxxxxxx xxxxxxxx xxxxxx
2&xxxx;xxxxxxxxx xx xxxxxxxx xxxxxxxxxxx xxxxxxx (XXX-5)
3&xxxx;50% xxxxxxxx xxxxx xxxxxxx xxxxxxx
XXXX
2xx)&xxxx;xxxxxxxx xxxxx xxxxx xxxxxxxxxx, xxxxxxxxxx x xxxxxxxxx
Xx xxxxxxxxxx obsahuje xxxxx dávka (0,5 xx):
Xxxxx xxxxxxxxxxx1&xxxx;xxxxx xxxxxxxxxx (xxxx Xxxxxx’ Edmonston) xx xxxx než 1x103&xxxx;XXXX50*
Xxxxx xxxxxxxxxxx1&xxxx;xxxxx xxxxxxxxxx (xxxx Xxxxx Xxxx™, xxxxxxx B) ne xxxx než 12,5x103&xxxx;XXXX50*
Xxxxx xxxxxxxx2&xxxx;xxxxx xxxxxxxxxx (xxxx Xxxxxx XX 27/3) xx méně xxx 1x103&xxxx;XXXX50*
*&xxxx;50% xxxxxxxx xxxxx xxxxxxx xxxxxxx
1&xxxx;xxxxxxxx na xxxxxxx xxxxxxxx xxxxxx.
2&xxxx;xxxxxxxx xx lidských xxxxxxxxxxx xxxxxxxx XX-38 fibroblastech.
3. Antigenní xxxxxxx očkovacích látek xxx xxxxxxxxx xxxxxxxx
3x)&xxxx;xxxxxxxx xxxxx xxxxx virové xxxxxxxxxx A xx xxxxxxx xxx xxxxxxx:
Xxxxx xxxxxxxxx X inactivatum
3b) očkovací xxxxx proti xxxxxx xxxxxxxxxx X ve xxxxxxx xxx děti:
Virus xxxxxxxxx A xxxxxxxxxxx
3x)&xxxx;xxxxxxxx xxxxx proti xxxxxxxxxx, xxxxxxxxxx x xxxxxxxxx:
Xxxxx xxxxx xxxxxxxx:
Xxxxxxxxxxx virus xxxxxxxxxx1&xxxx;(Xxxxxxx) xxx. 103,0&xxxx;xxxxxxxx xxxxx xxx buněčnou xxxxxxx503
Xxxxxxxxxxx xxxxx xxxxxxxxxx1&xxxx;(XXX 4385) xxx. 103,7&xxxx;xxxxxxxx xxxxx pro xxxxxxxx xxxxxxx503
Xxxxxxxx xxxxx xxxxxxxxxx2&xxxx;(Xxxxxx XX 27/3) min. 103,0&xxxx;xxxxxxxx xxxxx pro xxxxxxxx kulturu503
1 pomnoženo xx xxxxxxx xxxxxxxx xxxxxx
2&xxxx;xxxxxxxxx xx lidských xxxxxxxxxxx xxxxxxx (XXX-5)
3&xxxx;50% xxxxxxxx xxxxx xxxxxxx kultury
NEBO
3ca) očkovací xxxxx xxxxx xxxxxxxxxx, xxxxxxxxxx x xxxxxxxxx
Xx xxxxxxxxxx obsahuje xxxxx xxxxx (0,5 xx):
Xxxxx xxxxxxxxxxx1&xxxx;xxxxx xxxxxxxxxx (xxxx Xxxxxx’ Edmonston) xx xxxx než 1x103&xxxx;XXXX50*
Xxxxx xxxxxxxxxxx1&xxxx;xxxxx xxxxxxxxxx (xxxx Xxxxx Lynn™, xxxxxxx X) ne méně xxx 12,5x103&xxxx;XXXX50*
Xxxxx xxxxxxxx2&xxxx;xxxxx xxxxxxxxxx (xxxx Xxxxxx XX 27/3) xx xxxx xxx 1x1 103&xxxx;XXXX50*
*&xxxx;50% infekční xxxxx xxxxxxx kultury
1 vyrobeno xx xxxxxxx xxxxxxxx embryí.
2 vyrobeno xx lidských xxxxxxxxxxx xxxxxxxx XX-38 xxxxxxxxxxxxx.
&xxxx;
Xxxxxxx:
xxxx. XXXx. Xxxxx, XXx, XXX, EBIR, x. x.
Xxxxxxxxx
Xxxxxx předpis x. 420/2023 Xx. xxxxx xxxxxxxxx dnem 29.12.2023.
Ke xxx xxxxxxxx právní xxxxxxx xxxxx xxxxx xx xxxxxxxxx.
Xxxxx xxxxxxxxxxxx xxxxxxxx xxxxx xxxxxx xxxxxxxx xxxxxxxx x xxxxxxxx xxxx xxxxxxxxxxxxx, xxxxx xx xxxx xxxxxx derogační změna xxxxx uvedeného xxxxxxxx xxxxxxxx.