Plné znění - 249/2018 Sb.

Sdělení o antigenním složení očkovacích látek pro pravidelná, zvláštní a mimořádná očkování pro rok 2019

249/2018 Sb.

Sdělení Ministerstva zdravotnictví

INFORMACE

249

XXXXXXX

Xxxxxxxxxxxx xxxxxxxxxxxxx

xx xxx 25. xxxxx 2018

x xxxxxxxxxx xxxxxxx xxxxxxxxxx xxxxx xxx xxxxxxxxxx, xxxxxxxx x xxxxxxxxx xxxxxxxx pro rok 2019

 

Xxxxxxxxxxxx zdravotnictví xxxxx §80 xxxx. 1 xxxx. e) zákona x. 258/2000 Xx., x xxxxxxx xxxxxxxxx xxxxxx x x xxxxx xxxxxxxxx xxxxxxxxxxxxx xxxxxx, xx znění xxxxxxxxxx předpisů, xxxxxxx xx xxxxxxx doporučení Xxxxxxx xxxxxxxxxx xxxxxx xxxxxxxxx xxxxxxx xxxxxxxxxx xxxxx xxx xxxxxxxxxx, xxxxxxxx x xxxxxxxxx xxxxxxxx xxx xxx 2019:

1. Antigenní složení xxxxxxxxxx xxxxx pro xxxxxxxxxx očkování

1a) xxxxxxxxxxx xxxxxxxx látka xxxxx xxxxxxx, dávivému xxxxx (xxxxxxxxxx xxxxx), xxxxxx, xxxxxx přenosné xxxxx (xxxxxxxxxxxx xxxxx), xxxxxx xxxxxxxxxx B, nákazám xxxxxxxxx Xxxxxxxxxxx xxxxxxxxxx xxx x (DTaPHibVHBIPV):

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

Xxxxxxxxxxx xxxxxxxxxx¹ xx xxxx xxx 30 xxxxxxxxxxxxx xxxxxxxx (XX)

Xxxxxx xxxxxxxxxx¹ xx xxxx xxx 40 xxxxxxxxxxxxx jednotek (XX)

Xxxxxxxx Xxxxxxxxxx xxxxxxxxx:

Xxxxxxxxx xxxxxxxxxx (XX)¹ 25 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxxxx xxxxxxxxxxxx (XXX)¹ 25 xxxxxxxxxx

Xxxxxxxxxxx (XXX)¹ 8 mikrogramů

Antigenum xxxxxxxxx xxxxxxxxxxx X (XXx)^2,3 10 mikrogramů

Virus xxxxxxxxxxxxxxx inactivatum (XXX)

xxxxx 1 (kmen Xxxxxxx)⁴ 40 X xxxxxxxx xxxxxxxx

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

xxxxx 3 (xxxx Saukett)⁴ 32 X xxxxxxxx antigenu

Haemophilus xxxxxxxxxx typus x xxxxxxxxxxxxxxx

(Xxxxxxxxxxxxxxxxxxx phosphas) 10 xxxxxxxxxx

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

¹ xxxxxxxxxxx xx xxxxxxxx xxxxxxx, xxxxxxxxxxx (Xx(XX)₃) 0,5 miligramů Xx³⁺

² xxxxxxxx xxxxxxxxxxxxx XXX technologií na xxxxxxx xxxxxxxxxxxx buněk (Xxxxxxxxxxxxx xxxxxxxxxx)

³ adsorbováno xx xxxxxxxxxxx xxxxxxx (XxXX₄) 0,32 miligramů Xx³⁺

⁴ pomnoženo xx XXXX xxxxxxx

XXXX

1xx) xxxxxxxxxxx xxxxxxxx látka xxxxx xxxxxxx, xxxxxxxx xxxxx (xxxxxxxxxx xxxxx), tetanu, xxxxxx xxxxxxxx xxxxx (xxxxxxxxxxxx xxxxx), virové xxxxxxxxxx X, xxxxxxx xxxxxxxxx Xxxxxxxxxxx xxxxxxxxxx xxx b (XXxXXxxXXXXXX)

Xxxxx xxxxx¹ (0,5 xx) xxxxxxxx:

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

Xxxxxx xxxxxxxxxx ne méně xxx 40 xxxxxxxxxxxxx xxxxxxxx (IU)²

Antigeny Bordetelly xxxxxxxxx

Xxxxxxxxx anatoxinum 25 xxxxxxxxxx

Xxxxxxxxxxxxxx xxxxxxxxxxxx 25 xxxxxxxxxx

Xxxxx Xxxxxxxxxxxxxxx (xxxxxxxxxxxx)³

xxxxx 1 (Mahoney) 40 X jednotek antigenu⁴

typus 2 (XXX-1) 8 X jednotek xxxxxxxx⁴

xxxxx 3 (Xxxxxxx) 32 X xxxxxxxx xxxxxxxx⁴

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx X⁵ 10 mikrogramů

Polyribosylribitoli xxxxxxxx xxxxxxxxxx influenzae X 12 xxxxxxxxxx

(Xxxxxxxxxxxxxxxxxxx phosphas)

conjugata xxx tetani anatoxinum 22-36 xxxxxxxxxx

¹ xxxxxxxxxxx xx xxxxxxxxxxx hydroxid xxxxxxx (0,6 mg Xx³⁺)

² jako xxxxxx xxx xxxxxxxxxxxxx (p= 0,95)

³ xxxxxxxxx xx XXXX xxxxxxx

⁴ xxxx xxxxxxxxxxxx množství xxxxxxxx xxxxxxxxx xxxxxxx xxxxxxxxxxxxxx xxxxxxx

⁵ xxxxxxxx xxxxxxxxxxxxx XXX xxxxxxxxxxx v xxxxxxxxxxxx xxxxxxx Xxxxxxxxx xxxxxxxxxx

1x) xxxxxxxx látka xxxxx xxxxxxx, dávivému xxxxx (xxxxxxxxxx forma), xxxxxx (XXxX):

Xxxxx xxxxx (0,5 xx) xxxxxxxx xxxx xxxxxx xxxxx:

Xxxxxxxxxxx xxxxxxxxxx* ≥ 30 XX

Xxxxxx anatoxinum* ≥ 40 XX

Xxxxxxxxx xxxxxxxxxx* (XX) 25 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxxx filamentosum* (XXX) 25 xxxxxxxxxx

Xxxxxxxxxxx* (69xX) 8 xxxxxxxxxx

* adsorbováno xx xxxxxxxx xxxxxxx xxxxxx: 0,5 xxxxxxxxx

XXXX

1xx) Xxxxxxxx látka proti xxxxxxx, tetanu a xxxxxxxx kašli (xxxxxxxxxx) xx sníženým xxxxxxx xxxxxxxx

Xxxxx dávka (0,5 xx) obsahuje:

Diphtheriae xxxxxxxxxx - Minimálně 2 XX* (2 Xx)

Xxxxxx xxxxxxxxxx - Minimálně 20 IU* (5 Xx)

Xxxxxxxxx antigeny

Pertussis anatoxinum - 2,5 xxxxxxxxxx

Xxxxxxxxxxxxxx xxxxxxxxxxxx - 5 xxxxxxxxxx

Xxxxxxxxxxx - 3 xxxxxxxxxx

Xxxxxxxx, xxxx 2 xx 3 - 5 xxxxxxxxxx

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

* Xxxx xxxxxx xxxxxxx xxxxxxxxx xxxxxxxxxxxxx (p = 0,95) xxxxxxxx měřené xxxxx testu xxxxxxxxx x Xxxxxxxxx lékopisu.

NEBO

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

Xxxxx xxxxx (0,5 ml) xxxxxxxx:

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

Xxxxxx xxxxxxxxxx¹ xx xxxx než 20 xxxxxxxxxxxxx xxxxxxxx (IU) (5 Lf)

Bordetellae pertussis xxxxxxxx:

Xxxxxxxxx anatoxinum¹ 8 xxxxxxxxxx

Xxxxxxxxx xxxxxxxxxxxxxx xxxxxxxxxxxx¹ 8 mikrogramů

Pertussis xxxxxxxxx xxxxxxxx proteinum¹ 2,5 xxxxxxxxxx

¹ xxxxxxxxxxx na xxxxxxxxxxx xxxxxxxx hlinitý (Xx(XX)₃) 0,3 xxxxxxxxx Xx³⁺ x xxxxxxxxxxx xxxxxxx (XxXX₄) 0,2 xxxxxxxxx Xx³⁺

1x) xxxxxxxx xxxxx proti nákazám xxxxxxxxx Xxxxxxxxxxx influenzae xxx x:

Xxxxx dávka xxxxxxxxxxxxx xxxxxxx obsahuje:

Polysaccharidum Xxx purificatum (10 xxxxxxxxxx) xxx Xxxxxxxxx xxxxxxxx (přibližně 25 xxxxxxxxxx).

1x) očkovací xxxxx xxxxx xxxxxx:

Xxxxx xxxxx xxxxxxxx:

Xxxxxx anatoxinum - xxx. 40 xxxxxxxxxxxxx xxxxxxxx

1x) xxxxxxxx xxxxx xxxxx virové xxxxxxxxxx X v xxxxxx xxxxxxx:

Xxxxx xxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx B - 10 mikrogramů

1f) xxxxxxxx xxxxx xxxxx xxxxxx hepatitidě B x xxxxxxx xxxxxxx

Xxxxx xxxxx xxxxxxxx:

Xxxxxxxxx xxxxxxxxx xxxxxxxxxxx X - 20 xxxxxxxxxx

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

Xxxxx xxxxx xxxxxxxx:

Xxxxxxxxxxx virus xxxxxxxxxx¹ (Xxxxxxx) xxx. 10^3,0 xxxxxxxx dávka xxx xxxxxxxx xxxxxxx³₅₀

Xxxxxxxxxxx xxxxx xxxxxxxxxx¹ (XXX 4385, odvozený xx xxxxx Xxxxx Lynn)) xxx. 10^3,7 infekční xxxxx xxx xxxxxxxx xxxxxxx³₅₀

Xxxxxxxx xxxxx xxxxxxxxxx² (Xxxxxx XX 27/3) xxx. 10^3,0 xxxxxxxx xxxxx pro buněčnou xxxxxxx³₅₀

¹ xxxxxxxxx xx xxxxxxx xxxxxxxx xxxxxx

² xxxxxxxxx xx xxxxxxxx xxxxxxxxxxx xxxxxxx (MRC-5)

³ 50% xxxxxxxx xxxxx xxxxxxx kultury

NEBO

1h) xxxxxxxx xxxxx proti spalničkám, xxxxxxxxxx x xxxxxxxxx

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

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

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

Xxxxx xxxxxxxx² xxxxx xxxxxxxxxx (xxxx Wistar XX 27/3) xx xxxx xxx 1x103 XXXX₅₀*

* 50 % xxxxxxxx xxxxx xxxxxxx xxxxxxx

¹ xxxxxxxx xx buňkách xxxxxxxx xxxxxx,

² xxxxxxxx xx xxxxxxxx diploidních xxxxxxxx XX-38 fibroblastech.

1ch) xxxxxxxx látka xxxxx xxxxxx xxxxxxxx obrně x inaktivované xxxxx:

Xxxxx xxxxx obsahuje:

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

Xxxxx xxxxxxxxxxxxx inactivatum xxxxx 2 (XXX-1) .......8 antigenních X xxxxxxxx*

Xxxxx xxxxxxxxxxxxx xxxxxxxxxxx xxxxx 3 (Saukett)...32 xxxxxxxxxxx X jednotek*

* xxxx xxxxxxxx ekvivalentních xxxxxxxx xxxxxxxxx xxxxxx xxxxxx xxxxxxxxxxxxx metody.

1i) xxxxxxxx xxxxx xxxxxxxxxxx xxxxx xxxxxxxxxxxxx xxxxxxxx:

Xxxxx xxxxx xxxxxxxx:

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 1¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 3¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 4¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 5¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 6X¹ 2,2 µg

Streptococci xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 6B¹ 4,4 µg

Streptococci xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 7F¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 9X¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 14¹ 2,2 µg

Streptococci pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 18C¹ 2,2 µg

Streptococci pneumoniae xxxxxxxxxxxxxxx xxxxxxxxx 19X¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx sérotypus 19X¹ 2,2 µx

Xxxxxxxxxxxx xxxxxxxxxx xxxxxxxxxxxxxxx xxxxxxxxx 23F¹ 2,2 µx

¹ Konjugován x xxxxxx xxxxxxxxx XXX197 a xxxxxxxxxx xx xxxxxxxxxxx xxxxxxx (0,125 mg hliníku).

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

Jedna dávka (0,5 ml) xxxxxxxx:

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

Xxxxxx xxxxxxxxxx¹ xx méně xxx 20 xxxxxxxxxxxxx xxxxxxxx (XX) (5 Xx)

Xxxxxxxxxxx xxxxxxxxx xxxxxxxx:

Xxxxxxxxx anatoxinum¹- 8 mikrogramů

Pertussis xxxxxxxxxxxxxx xxxxxxxxxxxx¹ - 8 xxxxxxxxxx

Xxxxxxxxx¹ 2,5 xxxxxxxxxx

Xxxxx xxxxxxxxxxxxxxx xxxxxxxxxxx:

xxxxx 1 (xxxx Mahoney)² - 40 X xxxxxxxx xxxxxxxx

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

xxxxx 3 (xxxx Xxxxxxx)² - 32 X xxxxxxxx antigenu

¹ xxxxxxxxxxx xx xxxxxxxxxxx xxxxxxxx xxxxxxx (Al(OH)₃) 0,3 xxxxxxxxx Al³⁺ x xxxxxxxxxxx xxxxxxx (XxXX₄) 0,2 xxxxxxxxx Xx³⁺

² xxxxxxxxx na XXXX xxxxxxx

1x) xxxxxxxx xxxxx xxxxx tuberkulóze (BCG xxxxxxx)

1x) očkovací xxxxx xxxxx xxxxxx xxxxxxxxxx X pro xxxxx xxxxxxxx xx xxxxxxxxxxxx xxxxxxxx:

Xxxxx xxxxx (0,5 xx) xxxxxxx obsahuje:

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

¹ xxxxxxxxxx xx XX04X xxxxxxxxxx: - 3-X-xxxxxx-4'-xxxxxxxxxxxx-xxxxx X (MPL)2 50 xxxxxxxxxx

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

³ xxxxxxxx xx kultuře xxxxxxxxxxxx xxxxx (Xxxxxxxxxxxxx xxxxxxxxxx) xxxxxxxxxxxxx XXX xxxxxxxxxxx.

2. Xxxxxxxxx xxxxxxx xxxxxxxxxx xxxxx xxx xxxxxxxx xxxxxxxx

2x) xxxxxxxx xxxxx xxxxx virové xxxxxxxxxx X xx xxxxxxx xxx xxxxxxx:

Xxxxx xxxxx obsahuje:

Antigenum tegiminis xxxxxxxxxxx B - 20 xxxxxxxxxx

2x) očkovací xxxxx proti xxxxxxxxx

2x) xxxxxxxx xxxxx xxxxx xxxxxx xxxxxxxxxx X xx xxxxxxx pro xxxxxxx:

Xxxxx xxxxx obsahuje:

Hepatitis X virus xxxxxxxxxxx

2x) xxxxxxxx xxxxx proti xxxxxxxxxx, xxxxxxxxxx x xxxxxxxxx

Xxxxxxxxxxx xxxxx xxxxxxxxxx¹ (Xxxxxxx) xxx. 10^3,0 xxxxxxxx dávka xxx xxxxxxxx kulturu³₅₀

Parotitidis xxxxx xxxxxxxxxx¹ (XXX 4385) xxx. 10^3,7 xxxxxxxx xxxxx xxx xxxxxxxx xxxxxxx³₅₀

Xxxxxxxx virus xxxxxxxxxx² (Xxxxxx RA 27/3) xxx. 10^3,0 xxxxxxxx xxxxx xxx xxxxxxxx xxxxxxx³₅₀

¹ pomnoženo na xxxxxxx xxxxxxxx embryí

² xxxxxxxxx xx lidských xxxxxxxxxxx buňkách (XXX-5)

³ 50% infekční xxxxx xxxxxxx xxxxxx

XXXX

1x) xxxxxxxx xxxxx proti xxxxxxxxxx, xxxxxxxxxx a xxxxxxxxx

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

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

Xxxxx parotitidis¹ xxxxx xxxxxxxxxx (xxxx Xxxxx Xxxx^XX, xxxxxxx X) ne méně xxx 12,5x103 CCID₅₀*

Virus xxxxxxxx² vivum xxxxxxxxxx (xxxx Xxxxxx XX 27/3) xx méně xxx 1x103 XXXX₅₀*

* 50 % xxxxxxxx xxxxx buněčné kultury

¹ xxxxxxxx xx buňkách xxxxxxxx xxxxxx.

² xxxxxxxx xx xxxxxxxx diploidních xxxxxxxx XX-38 fibroblastech.

3. Xxxxxxxxx xxxxxxx očkovacích xxxxx pro xxxxxxxxx xxxxxxxx

3x) očkovací xxxxx xxxxx xxxxxx hepatitidě X xx formuli xxx dospělé:

Hepatitis X xxxxx inactivatum

3b) očkovací xxxxx xxxxx xxxxxx xxxxxxxxxx X ve xxxxxxx pro xxxx:

Xxxxx xxxxxxxxx X xxxxxxxxxxx

 

Xxxxxxx:

Xxx. xx Xxx. Vojtěch, XXX, x. r.

Informace

Právní xxxxxxx č. 249/2018 Xx. xxxxx xxxxxxxxx xxxx 15.11.2018.

Xx xxx xxxxxxxx xxxxxx xxxxxxx nebyl měněn xx doplňován.

Znění xxxxxxxxxxxx xxxxxxxx norem jiných xxxxxxxx xxxxxxxx x xxxxxxxx xxxx xxxxxxxxxxxxx, xxxxx xx jich xxxxxx xxxxxxxxx změna xxxxx xxxxxxxxx právního xxxxxxxx.