Communication from the Ministry of Health No. 261 / 2015 Coll.
Communication from the Ministry of Health on the antigenic composition of vaccines for regular, special and exceptional vaccination for 2016
Valid
Communication
Text versions:
09.10.2015
261
COMMUNICATION
Ministry of Health
of 22 September 2015
on the antigenic composition of vaccines for regular, special and exceptional vaccination for 2016
The Ministry of Health pursuant to § 80 (1) (e) of Act No. 258 / 2000 Coll., on the Protection of Public Health and on the amendment of certain related acts, as amended, provides for the antigenic composition of vaccines for regular, special and exceptional vaccination for 2016 on the basis of recommendations from the National Immunisation Commission:
1. Antigenic composition of vaccines for periodic vaccination
(1a) a combined diphtheria vaccine, an acellular cough, tetanus, polio (inactivated form), hepatitis B viral, Haemophilus influenzae type b (DTaPHibVHBIPV):
Diphtheria toxoid1 not less than 30 international units (IU)
Tetanus toxoid1 not less than 40 International Units (IU)
Bordetella pertussis antigens:
Pertussis toxoid1 25 micrograms
Haemagglutinin Filamentosum 1 25 micrograms
Pertactin 1 8 micrograms
Hepatitis B2,3 10 micrograms
Poliomyelitis virus (inactivated)
type 1 (Mahoney strain) 4 40 D antigen units
Type 2 (MEF-1 strain) 4 8 D antigen units
type 3 (Saukett strain) 4 32 D antigen units
Haemophilus influenzae type b polysaccharide 10 micrograms
(polyribosylribitol phosphate) 3
conjugata cum tetanus toxoid as carrier protein approximately 25 micrograms
OR
1aa) a combined diphtheria vaccine, an acellular cough, tetanus, polio (inactivated form), hepatitis B viral, Haemophilus influenzae type b (DTaPHibVHBIPV)
Diphtheria toxoid not less than 20 international units (IU) 2
Tetanus toxoid not less than 40 International Units (IU) 2
Bordetella pertussis antigens
Pertussis toxoid 25 micrograms
Haemagglutinum filamentosum 25 micrograms
Poliomyelitidis virus (inactivated) 3
type 1 (Mahoney) 40 D units of antigen 4
Type 2 (MEF-1) 8 D units of antigen 4
Type 3 (Saukett) 32 D units antigen 4
Hepatitis B5 antigen 10 micrograms
Haemophilus influenzae type b polysaccharide 12 micrograms
(Polyribosylribitol phosphate)
conjugata cum tetanus toxoid 22-36 micrograms
(1b) diphtheria, coughs (acellular form), tetanus (DTaP) vaccine:
Diphtheria toxoid ≥ 30 international units
Tetanus toxoid ≥ 40 international units
Pertussis toxoid (PT) 25 micrograms
Pertussis haemagglutinin Filamentosum (FHA) 25 micrograms
Pertactin (69kD) 8 micrograms
OR
1ba) Diphtheria, tetanus and cough (acellular) vaccine
| 1 dávka (0,5 ml) obsahuje: | Minimálně 2 IU*(2 Lf) |
| Diphtheriae anatoxinum | |
| Tetani anatoxinum | Minimálně 20 IU* (5 Lf) |
| Pertusové antigeny | |
| Pertussis anatoxinum | 2,5 mikrogramu |
| Haemagglutinum filamentosum | 5 mikrogramů |
| Pertactinum | 3 mikrogramy |
| Fimbriae, typi 2 et 3 | 5 mikrogramů |
| Adsorbováno na fosforečnan hlinitý | 1,5 mg (0,33 mg hliníku) |
OR
1bb) Diphtheria, tetanus and cough (acellular component) vaccine with reduced antigens
Diphtheria toxoid1 not less than 2 International Units (IU) (2,5 Lf)
Tetanus toxoid1 not less than 20 International Units (IU) (5 Lf)
Bordetellae pertussis antigen:
Pertussis toxoid1 8 micrograms
Pertussis haemagglutine filamentosum 1 8 micrograms
Pertussis membranae Extra protein 1 2.5 micrograms
1 adsorbed on aluminium hydroxide, hydrated (Al (OH) 3) 0,3 milligrams Al3 +
and aluminium phosphate (AlPO4) 0,2 milligrams Al3 +
1c) Diphtheria vaccine, coughs (acellular form), tetanus, influenza b infection (DTaPHib):
| Diphtheriae anatoxinum | min. 30 mezinárodních jednotek |
| Tetani anatoxinum | min. 40 mezinárodních jednotek |
| Pertussis anatoxinum (PT) | 25 mikrogramů |
| Pertussis haemaglutininum filamentosum | (FHA) 25 mikrogramů |
| Pertactinum (69kD) | 8 mikrogramů |
| Haemophilus influenzae B | 10 mikrogramů |
| cum anatoxino tetanico | 20-40 mikrogramů |
1d) Haemophilus influenzae type b:
1 dose of lyophilised vaccine contains: polysaccharide Hib Purificatum (10 micrograms) cum Anatoxin tetanico (approximately 25 micrograms).
(e) tetanus vaccine:
| Tetani anatoxinum | min. 40 mezinárodních jednotek |
1f) Viral hepatitis B vaccine from 16 years of age and above:
| Antigenum tegiminis hepatitidis B | 20 mikrogramů |
1g) measles, mumps and rubella vaccine:
Morbillorum virus attenuated (Schwarz) min. 103,0 infectious dose for cell culture50
Parotitidis attenuated virus (RIT 4385) min. 103,7 infectious dose for cell culture50
Rubeolae attenuated virus (Wistar RA 27 / 3) min. 103,0 infectious dose for cell culture50
(1h) an anti-polio vaccine in inactivated form:
| Virus poliomyelitis inactivatum typus 1 (Mahoney) | 40 antigenních D jednotek* |
| Virus poliomyelitis inactivatum typus 2 (MEF-1) | 8 antigenních D jednotek* |
| Virus poliomyelitis inactivatum typus 3 (Saukett) | 32 antigenních D jednotek* |
* or the amount of equivalent antigens determined using an appropriate immunochemical method.
1ch) Streptococcus pneumoniae vaccine in polysaccharide formulation:
Polysaccharide Streptococci pneumoniae type:
| 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, 33F | 25 mikrogramů z každého sérotypu |
(i) a vaccine conjugated against pneumococcal infections:
Pneumococcal polysaccharide serotype 1
Pneumococcal polysaccharide serotype 3
Pneumococcal polysaccharide serotype 4
Pneumococcal polysaccharide serotype 5
Pneumococcal polysaccharide serotype 6A
Pneumococcal polysaccharide serotype 6B
Pneumococcal polysaccharide serotype 7F
Pneumococcal polysaccharide serotype 9V
Pneumococcal polysaccharide serotype 14
Pneumococcal polysaccharide serotype 18C
Pneumococcal polysaccharide serotype 19A
Pneumococcal polysaccharide serotype 19F
Pneumococcal polysaccharide serotype 23F
1j) Diphtheria vaccine, coughs (acellular form), tetanus, polio (inactivated form):
| Diphtheriae anatoxinum | ne méně než 2 mezinárodní jednotky |
| Tetani anatoxinum | ne méně než 20 mezinárodních jednotek |
| Pertusové antigeny: | |
| Pertussis anatoxinum | 8 mikrogramů |
| Pertussis haemagglutinum filamentosum | 8 mikrogramů |
| Pertaktin | 2,5 mikrogramů |
| Virus poliomyelitidis inactivatum: | |
| typus 1 (kmen Mahoney) | 40 D jednotek antigenu |
| typus 2 (kmen MEF-1) | 8 D jednotek antigenu |
| typus 3 (kmen Saukett) | 32 D jednotek antigenu |
OR
1ja) diphtheria vaccine, coughs (acellular form), tetanus, polio communicable to children (inactivated form):
| Difterický toxoid | více nebo rovno 2 mezinárodní jednotky (2 Lf) | |
| Tetanický toxoid | více nebo rovno 20 mezinárodních jednotek (5 Lf) | |
| Pertusové antigeny: | ||
| Pertusový toxoid | 2,5 mikrogramu | |
| Filamentózní hemaglutinin | 5 mikrogramů | |
| Fimbrie typu 2+3 | 5 mikrogramů | |
| Pertaktin | 3 mikrogramy | |
| Virus poliomyelitis typu 1 (inaktivovaný) | 40 antigenních D jednotek | |
| Virus poliomyelitis typu 2 (inaktivovaný) | 8 antigenních D jednotek | |
| Virus poliomyelitis typu 3 (inaktivovaný) | 32 antigenních D jednotek | |
1l) tuberculosis vaccine:
| Mycobacterium bovis attenautum (BCG) stratus Danisuc 1331 ≥ 2,0 x 106 ≤ 8,0 x 106 CFU (živých zárodků) | 0,75 mg |
1m) Hepatitis B viral vaccine for persons included in the dialysis programme:
Hepatitis B surface antigen 20 micrograms; adjuvant AS04C containing 3-O-deacyl-4-monophosphoryl lipid A (MPL) 50 micrograms per dose
2. Antigenic composition of vaccines for specific vaccination
2a) Hepatitis B viral vaccine in adult formula:
| Antigenum tegiminis hepatitidis B | 20 mikrogramů |
(2b) rabies vaccine:
Rabiei inactivated virus (Wistar rabies PM / WI strain 38 1503- 3M more than or equal to 2,5 international units per dose (0,5 ml)
2c) Viral hepatitis vaccine And in the adult formula:
Hepatitis A Inactivated Virus
3. Antigenic composition of vaccines for emergency vaccination
3a) Viral hepatitis vaccine And in the adult formula:
Hepatitis A Inactivated Virus
3b. Viral hepatitis vaccine And in the formula for children:
Hepatitis A virus inactivated
In 2016, in view of the planned amendment of Decree No. 537 / 2006 Coll., on vaccination against infectious diseases, as amended, a possible modification of the antigenic composition of vaccines for regular vaccination cannot be excluded by publishing the new antigenic composition of these vaccines in the Collection of Laws.
Minister:
v. JUDr. Policar v. r.
Director of Legislation and Law
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Regulation Information
| Citation | Communication from the Ministry of Health No. 261 / 2015 Coll., on the antigenic composition of vaccines for regular, special and exceptional vaccination for 2016 |
|---|---|
| Regulation Type | Communication |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 09.10.2015 |
|---|---|
| Effective from | - |
| Effective until | - |
| Status | Valid |
Legal Areas:
Administrative law
Health
The regulation text is for informational purposes only.
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