Plné znění - 375/2024 Sb.

Sdělení Ministerstva zdravotnictví o antigenním složení očkovacích látek pro pravidelná, zvláštní a mimořádná očkování pro rok 2025

375/2024 Sb.
 

Sdělení Ministerstva zdravotnictví

INFORMACE

375

XXXXXXX

Xxxxxxxxxxxx xxxxxxxxxxxxx

xx dne 5. xxxxxxxx 2024

o xxxxxxxxxx xxxxxxx očkovacích xxxxx xxx pravidelná, xxxxxxxx a mimořádná xxxxxxxx xxx xxx 2025
&xxxx;

Xxxxxxxxxxxx xxxxxxxxxxxxx xxxxx §80 odst. 1 xxxx. x) zákona x. 258/2000 Xx., x xxxxxxx veřejného xxxxxx x x xxxxx některých xxxxxxxxxxxxx xxxxxx, xx znění xxxxxxxxxx xxxxxxxx, stanoví xx základě xxxxxxxxxx Xxxxxxx xxxxxxxxxx xxxxxx xxxxxxxxx xxxxxxx očkovacích xxxxx pro xxxxxxxxxx, xxxxxxxx x xxxxxxxxx xxxxxxxx pro xxx 2025:

1. Xxxxxxxxx xxxxxxx xxxxxxxxxx xxxxx xxx xxxxxxxxxx očkování

1a) xxxxxxxxxxx xxxxxxxx látka xxxxx xxxxxxx, xxxxxxxx xxxxx (xxxxxxxxxx xxxxx), xxxxxx, xxxxxx xxxxxxxx xxxxx (xxxxxxxxxxxx forma), xxxxxx xxxxxxxxxx X, xxxxxxx xxxxxxxxx Xxxxxxxxxxx xxxxxxxxxx xxx x (XXxXXxxXXXXXX)

Xx xxxxxxxxxxxx 1 dávka (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx xxxxxxxxxx¹ ne xxxx xxx 30 mezinárodních xxxxxxxx (XX)

Xxxxxx xxxxxxxxxx1 xx méně xxx 40 mezinárodních jednotek (XX)

Xxxxxxxx Bordetelly xxxxxxxxx:

Xxxxxxxxx xxxxxxxxxx (XX)¹ 25 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxxxx xxxxxxxxxxxx (XXX)¹ 25 mikrogramů

Pertactinum (XXX)¹ 8 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx X (XXx)^2,3 10 xxxxxxxxxx

Xxxxx xxxxxxxxxxxxxxx inactivatum (XXX)

xx xxx 1 (kmen Xxxxxxx)⁴ 40 D xxxxxxxx xxxxxxxx

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

xxxxx 3 (xxxx Xxxxxxx)⁴ 32 X xxxxxxxx xxxxxxxx

Xxxxxxxxxxx influenzae typus x xxxxxxxxxxxxxxx

(Xxxxxxxxxxxxxxxxxxx phosphas) 10 xxxxxxxxxx

xxxx. xxx xxxxxx. xxxxxxxx jako xxxxx xxxxxxx xxxxxxxxx 25 mikrogramů

¹ adsorbováno xx xxxxxxxx xxxxxxx, xxxxxxxxxxx (Xx(XX)₃) 0,5 xxxxxxxxx Al³⁺

² xxxxxxxx xxxxxxxxxxxxx XXX xxxxxxxxxxx xx xxxxxxx xxxxxxxxxxxx xxxxx (Saccharomyces cerevisiae)

³ xxxxxxxxxxx na fosforečnan xxxxxxx (XxXX₄) 0,32 xxxxxxxxx Al³⁺

⁴ xxxxxxxxx xx VERO buňkách

NEBO

1aa) xxxxxxxxxxx xxxxxxxx xxxxx xxxxx xxxxxxx, dávivému xxxxx (acelulární forma), xxxxxx, xxxxxx xxxxxxxx xxxxx (xxxxxxxxxxxx xxxxx), xxxxxx hepatitidě X, xxxxxxx xxxxxxxxx Xxxxxxxxxxx xxxxxxxxxx xxx x (XXxXXxxXXXXXX)

Xxxxx xxxxx¹ (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx anatoxinum xx xxxx xxx 20 mezinárodních jednotek (XX)^2,4 (30 Lf)

Tetani xxxxxxxxxx xx méně xxx 40 xxxxxxxxxxxxx xxxxxxxx (XX)^3,4 (10 Xx)

Xxxxxxxx Xxxxxxxxxx xxxxxxxxx

Xxxxxxxxx xxxxxxxxxx 25 mikrogramů

Pertussis xxxxxxxxxxxxxxxx xxxxxxxxxxxx 25 xxxxxxxxxx

Xxxxx Poliomyelitidis (xxxxxxxxxxxx)⁵

xxxxx 1 (Xxxxxxx) 29 X jednotek xxxxxxxx⁶

xxxxx 2 (XXX-1) 7 X xxxxxxxx xxxxxxxx⁶

xxxxx 3 (Xxxxxxx) 26 X jednotek antigenu⁶

Tegiminis xxxxxxxxxxx B antigenum⁷ 10 xxxxxxxxxx

Xxxxxxxxxx xxxxxxxxxx xxxx X xxxxxxxxxxxxxxx (Xxxxxxxxxxxxxxxxxxx xxxxxxxx) 12 xxxxxxxxxx xxxxxxxxxx xxx xxxxxx xxxxxxxx 22-36 xxxxxxxxxx

¹ Adsorbováno xx xxxxxxxxxxx xxxxxxxx hlinitý (0,6 xx Xx³⁺)

² Xxxx spodní mez xxxxxxxxxxxxx (p = 0,95) x ne xxxx xxx 30 XX xxxx střední xxxxxxx

³ Xxxx xxxxxx xxx xxxxxxxxxxxxx (x = 0,95)

⁴ Xxxx xxxxxxxxxxxx aktivita stanovená xxxxxxxxxx xxxxxxxxxxx

⁵ Kultivováno xx Xxxx buňkách

⁶ Xxxx množství xxxxxxxx xxxx xxxxx stejná xxxx xx, xxxxx xxxx xxxxx vyjádřená xxxx 40-8-32 D xxxxxxxx antigenu xxx xxxxx xxxx 1, 2 x 3, xxx měření xxxxx xxxxxxx xxxxxxxxxxxxxx xxxxxxx

⁷ xxxxxxxx xxxxxxxxxxxxx XXX xxxxxxxxxxx v xxxxxxxxxxxx xxxxxxx Xxxxxxxxx polymorpha

NEBO

1ab) Xxxxxxx proti xxxxxxx, xxxxxx, xxxxxxxx kašli (xxxxxxxxxx xxxxxxxxxx), xxxxxxxxxx X (xXXX), dětské xxxxxxxx xxxxx (inaktivovaná) x konjugovaná xxxxxxx xxxxx Xxxxxxxxxxx xxxx x (xxxxxxxxxxx)

Xxxxx xxxxx (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx xxxxxxxxxx1 xx xxxx xxx 20 XX⁶

Xxxxxx xxxxxxxxxx1 ne méně xxx 40 XX⁶

Xxxxxxxx Xxxxxxxxxxx pertusis¹

Pertussis xxxxxxxxxx (XX) 20 xxxxxxxxxx

Xxxxxxxxxxxxxxx xxxxxxxxxxxx (XXX) 20 xxxxxxxxxx

Xxxxxxxxxxx (PRN) 3 xxxxxxxxxx

Xxxxxxxx xxxx 2 xx 3 (XXX) 5 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx B ^2,3 10 xxxxxxxxxx

Xxxxx xxxxxxxxxxxxxxx (xxxxxxxxxxx)⁴

Xxxxx 1 (Xxxxxxx) 40 X xxxxxxxx xxxxxxxx⁵

Xxxxx 2 (XXX-1) 8 D xxxxxxxx xxxxxxxx⁵

Xxxxx 3 (Xxxxxxx) 32 X xxxxxxxx xxxxxxxx⁵

Xxxxxxxxxxxxxx Xxxxxxxxxx influenzae xxxxx b

(Polyribosylribitoli xxxxxxxx) 3 xxxxxxxxxx xxxxxxxxxx xxx xxxxxxxxx xxxxxxxxxxxx xxxxx x² 50 xxxxxxxxxx

¹ adsorbováno xx xxxxxxxxxxx hlinitý (0,17 xx Xx³⁺)

² adsorbováno xx hydratovaný hydroxid xxxxxxx sulfát (0,15 xx Al³⁺)

³ xxxxxxxx xxxxxxxxxxxxx DNA technologií x xxxxxxxxxxxx xxxxxxx Xxxxxxxxxxxxx cerevisiae

⁴ xxxxxxxxx xx Xxxx buňkách

⁵ xxxx ekvivalentní množství xxxxxxxx xxxxxxxxx vhodnou xxxxxxxxxxxxxx xxxxxxx

⁶ nebo xxxxxxxxxxxx aktivita xxxxxxxxx xxxxxxxxxxxx xxxxxxxxxxx

1x) xxxxxxxx xxxxx proti xxxxxxx, xxxxxxxx xxxxx (xxxxxxxxxx xxxxx), tetanu (DTaP)

Jedna xxxxx (0,5 ml) xxxxxxxx xxxx xxxxxx xxxxx:

Xxxxxxxxxxx anatoxinum* ≥ 30 IU

Tetani xxxxxxxxxx* ≥ 40 IU

Pertussis xxxxxxxxxx* (XX) 25 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxxxxx* (XXX) 25 mikrogramů

Pertactinum* (69xX) 8 xxxxxxxxxx

* xxxxxxxxxxx na xxxxxxxx xxxxxxx xxxxxx: 0,5 xxxxxxxxx

XXXX

1xx) Očkovací xxxxx xxxxx xxxxxxx, tetanu x dávivému xxxxx (xxxxxxxxxx) xx xxxxxxxx xxxxxxx xxxxxxxx (Tdap)

Jedna xxxxx (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx anatoxinum - Xxxxxxxxx 2 XX* (2 Lf)

Tetani anatoxinum - Minimálně 20 XX* (5 Xx)

Xxxxxxxxx xxxxxxxx

Xxxxxxxxx xxxxxxxxxx - 2,5 mikrogramů

Haemagglutinum xxxxxxxxxxxx - 5 mikrogramů

Pertactinum - 3 xxxxxxxxxx

Xxxxxxxx, xxxx 2 xx 3 - 5 xxxxxxxxxx

Xxxxxxxxxxx na xxxxxxxxxxx xxxxxxx - 1,5 xx (0,33 xx xxxxxxx)

* Xxxx xxxxxx xxxxxxx xxxxxxxxx spolehlivosti (x = 0,95) xxxxxxxx měřené xxxxx xxxxx xxxxxxxxx x Xxxxxxxxx xxxxxxxx

XXXX

1xx) Xxxxxxxx xxxxx proti xxxxxxx, xxxxxx x xxxxxxxx xxxxx (acelulární komponenta) xx xxxxxxxx obsahem xxxxxxxx (Xxxx)

Xxxxx xxxxx (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx xxxxxxxxxx¹ ne méně xxx 2 xxxxxxxxxxx xxxxxxxx (IU) (2,5 Xx)

Xxxxxx anatoxinum¹ xx xxxx xxx 20 xxxxxxxxxxxxx xxxxxxxx (XX) (5 Lf)

Bordetellae xxxxxxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxxx¹ 8 xxxxxxxxxx

Xxxxxxxxx haemagglutinum filamentosum¹ 8 xxxxxxxxxx

Xxxxxxxxxxx¹ 2,5 xxxxxxxxxx

¹ adsorbováno xx xxxxxxxxxxx xxxxxxxx xxxxxxx (X1(XX)₃) 0,3 xxxxxxxxx Xx³⁺ a xxxxxxxxxxx xxxxxxx (XxXX₄) 0,2 xxxxxxxxx Al³⁺

1c) xxxxxxxx xxxxx xxxxx xxxxxxx xxxxxxxxx Xxxxxxxxxxx xxxxxxxxxx xxx b:

Po xxxxxxxxxxxx 1 dávka (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx influenzae xxxxx b xxxx xxxxxxxxxxx 10 xxxxxxxxxx

xxxxxxxxxxx x xxxxxxxxxx toxoidem xxxx xxxxxxxxxxx xxxxxxx xxxxxxxxx 25 mikrogramů

1d) xxxxxxxx xxxxx xxxxx xxxxxx:

Xxxxx dávka obsahuje:

Tetani xxxxxxxxxx - xxx. 40 xxxxxxxxxxxxx xxxxxxxx

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

Xxxxx xxxxx obsahuje:

Antigenum xxxxxxxxx xxxxxxxxxxx X - 10 xxxxxxxxxx

1x) xxxxxxxx xxxxx proti virové xxxxxxxxxx B x xxxxxxx formuli

Jedna xxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx X - 20 xxxxxxxxxx

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

xxxxx rekonstituované xxxxxxx (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx xxxxx xxxxxxxxxx¹ (Xxxxxxx) min. 10^3,0 xxxxxxxx dávka xxx xxxxxxxx xxxxxxx₅₀³

Xxxxxxxxxxx virus xxxxxxxxxx¹ (RIT 4385) xxx. 10^3,7 xxxxxxxx xxxxx xxx xxxxxxxx xxxxxxx₅₀³

Xxxxxxxx xxxxx xxxxxxxxxx² (Xxxxxx XX 27/3) xxx. 10^3,0 infekční xxxxx pro buněčnou xxxxxxx₅₀³

¹ xxxxxxxxx xx xxxxxxx xxxxxxxx xxxxxx

² xxxxxxxxx na lidských xxxxxxxxxxx buňkách (XXX-5)

³ 50% infekční xxxxx xxxxxxx xxxxxxx

XXXX

1xx) xxxxxxxx xxxxx xxxxx spalničkám, xxxxxxxxxx x xxxxxxxxx

Xx xxxxxxxxxx xxxxxxxx xxxxx xxxxx (0,5 xx):

Xxxxx xxxxxxxxxxx¹ xxxxx xxxxxxxxxx (xxxx Enders’ Edmonston) xx xxxx xxx 1x10³ XXXX₅₀*

Xxxxx xxxxxxxxxxx¹ xxxxx attenuatum (xxxx Xxxxx Xxxx™, hladina X) xx xxxx xxx 12,5x10³ XXXX₅₀*

Xxxxx xxxxxxxx² xxxxx xxxxxxxxxx (xxxx Xxxxxx XX 27/3) ne xxxx xxx 1x10³ CCID₅₀*

* 50% infekční dávka xxxxxxx xxxxxxx

¹ xxxxxxxx xx xxxxxxx xxxxxxxx xxxxxx.

² vyrobeno na xxxxxxxx xxxxxxxxxxx xxxxxxxx XX-38 xxxxxxxxxxxxx

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

Xxxxx xxxxx (0,5 xx) xxxxxxxx:

Xxxxx xxxxxxxxxxxxx xxxxxxxxxxx xxxxx 1 (Xxxxxxx) ... 29 xxxxxxxxxxx D xxxxxxxx**

Xxxxx poliomyelitis inactivatum xxxxx 2 (MEF-1) ... 7 antigenních X jednotek**

Virus xxxxxxxxxxxxx xxxxxxxxxxx typus 3 (Xxxxxxx) ) ... 26 xxxxxxxxxxx D xxxxxxxx**

* Kultivováno xx XXXX xxxxxxx

** Tato xxxxxxxx xxxxxxxx xxxx xxxxx stejná xxxx xx, xxxxx xxxx xxxxx xxxxxxxxx xxxx 40-8-32 X xxxxxxxx xxxxxxxx xxx xxxxx xxxx 1, 2 x 3, xxx xxxxxx xxxxx xxxxxxx xxxxxxxxxxxxxx xxxxxxx

1xx) xxxxxxxxxxx xxxxxxxx xxxxx proti xxxxxxxxxxxxx xxxxxxxx

Xxxxx dávka (0,5 ml) obsahuje:

Polysacharid xxxxxxxx (pneumokoka) Xxxxxxxxxxxxx xxxxxxxxxx sérotypu 1 ^1,2 2,2 µg

polysacharid xxxxxxxx (pneumokoka) Streptococcus xxxxxxxxxx xxxxxxxx 3 ^1,2 2,2 µg

polysacharid xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 4 ^1,2 2,2 µg

polysacharid xxxxxxxx (xxxxxxxxxx) Streptococcus xxxxxxxxxx xxxxxxxx 5 ^1,2 2,2 µx

xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Streptococcus xxxxxxxxxx xxxxxxxx 6X ^1,2 2,2 µx

xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 6X ^1,2 4,4 µx

xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx sérotypu 7F ^1,2 2,2 µg

polysacharid xxxxxxxx (xxxxxxxxxx) Streptococcus xxxxxxxxxx xxxxxxxx 8 ^1,2 2,2 µx

xxxxxxxxxxxx xxxxxxxx (pneumokoka) Xxxxxxxxxxxxx xxxxxxxxxx sérotypu 9 X ^1,2 2,2 µx

xxxxxxxxxxxx xxxxxxxx (pneumokoka) Xxxxxxxxxxxxx pneumoniae xxxxxxxx 10X ^1,2 2,2 µx

xxxxxxxxxxxx bakterie (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx sérotypu 11X ^1,2 2,2 µx

xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 12X ^1,2 2,2 µx

xxxxxxxxxxxx bakterie (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 14 ^1,2 2,2 µx

xxxxxxxxxxxx xxxxxxxx (pneumokoka) Xxxxxxxxxxxxx pneumoniae xxxxxxxx 15X ^1,2 2,2 µx

xxxxxxxxxxxx bakterie (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx sérotypu 18X ^1,2 2,2 µx

xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx sérotypu 19X ^1,2 2,2 µx

xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx pneumoniae sérotypu 19X ^1,2 2,2 µx

xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 22X ^1,2 2,2 µx

xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx pneumoniae sérotypu 23X ^1,2 2,2 µx

xxxxxxxxxxxx xxxxxxxx (xxxxxxxxxx) Xxxxxxxxxxxxx pneumoniae xxxxxxxx 33X ^1,2 2,2 µx

1 Xxxxxxxxxx s xxxxxx proteinem CRM₁₉₇ (xxxxxxxxx 51 µg xx xxxxx)

2 Xxxxxxxxxx xx xxxxxxxxxxx hlinitý (0,125 xx xxxxxxx xx dávku)

NEBO

1cha) očkovací xxxxx xxxxx xxxxxxxxxxxxx xxxxxxxx xxxxxxxxx v xxxxxxxxxx xxxxxxxx:

1xxxx) xxxxxxxxxxx xxxxxxxx xxxxx obsahuje:

Streptococci xxxxxxxxxx xxxxxxxx 1^1,2 xxxxxxxxxxxxxxx 2,0 mikrogramů

Streptococci xxxxxxxxxx xxxxxxxx 3^1,2 xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx

Xxxxxxxxxxxx xxxxxxxxxx serotypi 4^1,2 xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 5^1,2 xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 6X^1,2 xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 6X^1,2 xxxxxxxxxxxxxxx 4,0 xxxxxxxxxx

Xxxxxxxxxxxx xxxxxxxxxx serotypi 7X^1,2 xxxxxxxxxxxxxxx 2,0 mikrogramů

Streptococci xxxxxxxxxx xxxxxxxx 9X^1,2 xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx

Xxxxxxxxxxxx xxxxxxxxxx serotypi 14^1,2 xxxxxxxxxxxxxxx 2,0 mikrogramů

Streptococci xxxxxxxxxx xxxxxxxx 18X^1,2 xxxxxxxxxxxxxxx 2,0 mikrogramů

Streptococci xxxxxxxxxx xxxxxxxx 19A^1,2 xxxxxxxxxxxxxxx 2,0 mikrogramů

Streptococci xxxxxxxxxx sérotypu 19F^1,2 xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 22F^1,2 xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxx 23X^1,2 xxxxxxxxxxxxxxx 2,0 mikrogramů

Streptococci xxxxxxxxxx serotypi 33X^1,2 xxxxxxxxxxxxxxx 2,0 xxxxxxxxxx

¹ Xxxxxxxxxx x xxxxxxxxxxx xxxxxxx XXX₁₉₇, XXX₁₉₇ xx xxxxxxxxx xxxxxx xxxxxxxxxxxx xxxxxx (pocházejícího x Corynebacterium diphtheriae X7) rekombinantně exprimováného x Xxxxxxxxxxx fluorescens

² Xxxxxxxxxx xx adjuvans xxxxxxxxxxx xxxxxxx

X

1xxxx) xxxx xxxxxxxxxxx xxxxxxxx látka xxxxxxxx:

xx 25 xxxxxxxxxxxx xxxxxxxxxxxxx 23 pneumokokových xxxxxxxxxxxxxxxxx xxxxxxxx: 1, 2, 3, 4, 5, 6X, 7F, 8, 9N, 9X, 10X, 11A, 12F, 14, 15X, 17X, 18X, 19X, 19X, 20, 22F, 23X, 33X

XXXX

1xxx) očkovací látky xxxxx xxxxxxxxxxxxx xxxxxxxx xxxxxxxxx x sekvenčním xxxxxxxx:

1xxxx) konjugovaná xxxxxxxx xxxxx xxxxxxxx:

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 1¹ 2,2µx

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 3¹ 2,2 µx

Xxxxxxxxxxxx pneumoniae polysaccharidum xxxxxxxxx 4¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx polysaccharidum xxxxxxxxx 5¹ 2,2 µx

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 6A¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 6X¹ 4,4 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 7X¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 9X¹ 2,2 µx

Xxxxxxxxxxxx pneumoniae polysaccharidum xxxxxxxxx 14¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 18C¹ 2,2 µx

Xxxxxxxxxxxx pneumoniae polysaccharidum xxxxxxxxx 19A¹ 2,2 µx

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 19X¹ 2,2 µx

Xxxxxxxxxxxx pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 23X¹ 2,2 µx

¹ Xxxxxxxxxx x xxxxxx xxxxxxxxx CRM₁₉₇ x xxxxxxxxxx na xxxxxxxxxxx xxxxxxx (0,125 xx xxxxxxx)

X

1xxxx) xxxx xxxxxxxxxxx xxxxxxxx látka xxxxxxxx:

xx 25 mikrogramech xxxxxxxxxxxxx 23 xxxxxxxxxxxxxx xxxxxxxxxxxxxxxxx xxxxxxxx: 1, 2, 3, 4, 5, 6X, 7F, 8, 9N, 9X, 10X, 11A, 12F, 14, 15X, 17F, 18X, 19X, 19A, 20, 22F, 23X, 33X

1x) xxxxxxxx látka xxxxx záškrtu, dávivému xxxxx (xxxxxxxxxx xxxxx), xxxxxx, dětské xxxxxxxx xxxxx (xxxxxxxxxxxx xxxxx):

Xxxxx xxxxx (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx xxxxxxxxxx¹ - xx méně xxx 2 xxxxxxxxxxx xxxxxxxx (XX) (2,5 Xx)

Xxxxxx xxxxxxxxxx¹-&xxxx; xx xxxx xxx 20 xxxxxxxxxxxxx xxxxxxxx (IU) (5 Xx)

Xxxxxxxxxxx xxxxxxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxxx¹ - 8 xxxxxxxxxx

Xxxxxxxxx haemagglutinum filamentosum¹ - 8 mikrogramů

Pertaktin1 2,5 mikrogramů

Virus poliomyelitidis xxxxxxxxxxx:

xxxxx 1 (kmen Xxxxxxx)² 40 D xxxxxxxx antigenu

typus 2 (xxxx MEF-1)² 8 X xxxxxxxx xxxxxxxx

xxxxx 3 (xxxx Saukett)² 32 X xxxxxxxx xxxxxxxx

¹ adsorbováno xx xxxxxxxxxxx xxxxxxxx hlinitý (Xx(XX)₃) 0,3 miligramu Xx³⁺ x fosforečnan xxxxxxx (XxXX₄) 0,2 xxxxxxxxx Al³⁺

² xxxxxxxxx xx XXXX xxxxxxx

XXXX

1xx) xxxxxxxx látka proti xxxxxxx, xxxxxxxx kašli (xxxxxxxxxx forma), xxxxxx, xxxxxx xxxxxxxx obrně (xxxxxxxxxxxx forma):

Jedna xxxxx (0,5 xx) obsahuje:

Diphtheriae xxxxxxxxxx minimálně 2 XX¹ (2 Lf)

Tetani xxxxxxxxxx minimálně 20 XX¹ (5 Lf)

Pertusové xxxxxxxx:

Xxxxxxxxx anatoxinum 2,5 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxxxx xxxxxxxxxxxx 5 xxxxxxxxxx

Xxxxxxxxxxx 3 xxxxxxxxxx

Xxxxxxxx, xxxx 2 xx 3 5 xxxxxxxxxx

Xxxxx xxxxxxxxxxxxxxx (xxxxxxxxxxx)²

xxxxx 1 (Mahoney) 29 X xxxxxxxx antigenu³

typus 2 (XXX1) 7 X jednotek antigenu³

typus 3 (Xxxxxxx) 26 X xxxxxxxx antigenu³

Adsorbováno xx fosforečnan xxxxxxx 1,5 xx (0,33 xx Al³⁺)

¹ Jako xxxxxx hranice intervalu xxxxxxxxxxxxx (x = 0,95) xxxxxxxx xxxxxx xxxxx xxxxx xxxxxxxxx x Evropském xxxxxxxx

² Xxxxxxxxxxx xx Vero xxxxxxx

³ Tato množství xxxxxxxx jsou xxxxx xxxxxx xxxx ta, xxxxx xxxx dříve xxxxxxxxx jako 40-8-32 X jednotek xxxxxxxx xxx virus xxxx 1, 2 x 3, xxx xxxxxx xxxxx vhodnou xxxxxxxxxxxxxx xxxxxxx

* Xxxx xxxxxx xxxxxxx xxxxxxxxx xxxxxxxxxxxxx (x = 0,95) xxxxxxxx xxxxxx xxxxx xxxxx xxxxxxxxx x Xxxxxxxxx xxxxxxxx

** Xxxxxxxxxxx xx Vero xxxxxxx.

1x) xxxxxxxx xxxxx proti xxxxxxxxxxx (XXX xxxxxxx)

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

Xxxxx xxxxx (0,5 ml) xxxxxxx obsahuje:

Antigenum tegiminis xxxxxxxxxxx X^1,2,3 - 20 xxxxxxxxxx

¹ xxxxxxxxxx xx XX04X xxxxxxxxxx: - 3-O-deacyl-4'-monofosforyl-lipid X (XXX)² 50 xxxxxxxxxx

² xxxxxxxxxxx na fosforečnan xxxxxxx (xxxxxx 0,5 xxxxxxxxx Xx³⁺)

³ vyrobeno xx kultuře xxxxxxxxxxxx xxxxx (Saccharomyces cerevisiae) xxxxxxxxxxxxx XXX technologií.

2. Xxxxxxxxx xxxxxxx xxxxxxxxxx xxxxx xxx xxxxxxxx xxxxxxxx

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

Xxxxx xxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx X - 20 xxxxxxxxxx

2x) xxxxxxxx xxxxx xxxxx xxxxxxxxx

2x) xxxxxxxx xxxxx xxxxx xxxxxx xxxxxxxxxx A xx xxxxxxx pro dospělé:

Jedna xxxxx obsahuje:

Hepatitis A xxxxx xxxxxxxxxxx

2x) xxxxxxxx xxxxx xxxxx spalničkám, xxxxxxxxxx x xxxxxxxxx:

1 xxxxx xxxxxxxxxxxxxxx vakcíny (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx xxxxx xxxxxxxxxx¹ (Xxxxxxx) xxx. 10^3,0 infekční xxxxx xxx xxxxxxxx xxxxxxx₅₀³

Xxxxxxxxxxx virus xxxxxxxxxx¹ (XXX 4385) xxx. 10^3,7 xxxxxxxx xxxxx xxx xxxxxxxx xxxxxxx₅₀³

Xxxxxxxx xxxxx xxxxxxxxxx² (Xxxxxx XX 27/3) min. 10^3,0 infekční xxxxx xxx buněčnou xxxxxxx₅₀³

¹ xxxxxxxxx na buňkách xxxxxxxx embryí

² xxxxxxxxx xx xxxxxxxx diploidních xxxxxxx (XXX-5)

³ 50% xxxxxxxx xxxxx xxxxxxx xxxxxxx

XXXX

2xx) xxxxxxxx látka xxxxx spalničkám, příušnicím x xxxxxxxxx

Xx xxxxxxxxxx xxxxxxxx jedna dávka (0,5 xx):

Xxxxx xxxxxxxxxxx¹ xxxxx xxxxxxxxxx (xxxx Xxxxxx’ Xxxxxxxxx) xx xxxx než 1x10³ XXXX₅₀*

Xxxxx xxxxxxxxxxx¹ xxxxx xxxxxxxxxx (kmen Jeryl Xxxx™, xxxxxxx X) xx xxxx xxx 12,5x10³ XXXX₅₀*

Xxxxx xxxxxxxx² xxxxx attenuatum (xxxx Xxxxxx XX 27/3) xx méně než 1x10³ CCID₅₀*

* 50% xxxxxxxx xxxxx xxxxxxx xxxxxxx

¹ xxxxxxxx xx xxxxxxx xxxxxxxx xxxxxx

² xxxxxxxx xx lidských xxxxxxxxxxx buňkách XX-38 xxxxxxxxxxxxx.

3. Xxxxxxxxx xxxxxxx xxxxxxxxxx xxxxx xxx xxxxxxxxx xxxxxxxx

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

Xxxxx xxxxxxxxx X xxxxxxxxxxx

3x) xxxxxxxx xxxxx xxxxx xxxxxx hepatitidě X xx formuli xxx xxxx:

Xxxxx hepatitis A xxxxxxxxxxx

3x) očkovací látka xxxxx xxxxxxxxxx, xxxxxxxxxx x zarděnkám:

1 xxxxx xxxxxxxxxxxxxxx xxxxxxx (0,5 xx) xxxxxxxx:

Xxxxxxxxxxx xxxxx xxxxxxxxxx¹ (Schwarz) min. 10^3,0 xxxxxxxx xxxxx xxx buněčnou xxxxxxx₅₀³

Xxxxxxxxxxx xxxxx xxxxxxxxxx¹ (XXX 4385) min. 10^3,7 xxxxxxxx dávka pro xxxxxxxx xxxxxxx₅₀³

Xxxxxxxx virus xxxxxxxxxx² (Wistar RA 27/3) min. 10^3,0 xxxxxxxx xxxxx xxx xxxxxxxx xxxxxxx₅₀³

¹ pomnoženo xx xxxxxxx kuřecích xxxxxx

² xxxxxxxxx na xxxxxxxx xxxxxxxxxxx buňkách (XXX-5)

³ 50% infekční xxxxx xxxxxxx xxxxxxx

XXXX

3xx) xxxxxxxx xxxxx xxxxx xxxxxxxxxx, příušnicím x xxxxxxxxx

Xx xxxxxxxxxx xxxxxxxx xxxxx dávka (0,5 xx):

Xxxxx morbillorum¹ vivum xxxxxxxxxx (kmen Xxxxxx’ Xxxxxxxxx) xx xxxx xxx 1x10³ XXXX₅₀*

Xxxxx xxxxxxxxxxx¹ xxxxx xxxxxxxxxx (xxxx Xxxxx Xxxx™, xxxxxxx X) xx xxxx než 12,5x10³ XXXX₅₀*

Xxxxx rubeolae² xxxxx xxxxxxxxxx (xxxx Wistar XX 27/3) xx xxxx xxx 1x110³ XXXX₅₀*

* 50% xxxxxxxx xxxxx xxxxxxx xxxxxxx

¹ xxxxxxxx xx buňkách xxxxxxxx xxxxxx

² vyrobeno xx xxxxxxxx xxxxxxxxxxx xxxxxxxx WI-38 xxxxxxxxxxxxx.
&xxxx;

Xxxxxxx:

xxxx. XXXx. Válek, XXx., XXX, XXXX, x. x.

Xxxxxxxxx

Xxxxxx xxxxxxx x. 375/2024 Xx. nabyl xxxxxxxxx dnem 10.12.2024.

Xx xxx xxxxxxxx xxxxx xxxxx či xxxxxxxxx.

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