Hexaxim

Ország: Örményország

Nyelv: angol

Forrás: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktív összetevők:

diphtheria toxoid, tetanus toxoid, pertussis toxoid/filamentous haemagglutinin, poliovirus types 1/2/3, hepatitis B surface antigen, haemophilus infuenzae type b polysaccharide, haemophilus infuenzae type b polysaccharide conjugated to tetanus protein

Beszerezhető a:

Sanofi Pasteur SA

INN (nemzetközi neve):

diphtheria toxoid, tetanus toxoid, pertussis toxoid/filamentous haemagglutinin, poliovirus types 1/2/3, hepatitis B surface anti

Adagolás:

20IU/0.5ml+40IU/0.5ml+25/25mcg/0.5ml+40/8/32 DU/0.5ml+10mcg/0.5ml+12mcg/0.5ml+22-36mcg/0.5ml

Gyógyszerészeti forma:

suspension for injection

Recept típusa:

Prescription

Termékjellemzők

RA_1212298 - version 2.0
Hexaxim - Product Information EN - EMA approved 28 April 2016
2
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
RA_1212298 - version 2.0
Hexaxim - Product Information EN - EMA approved 28 April 2016
3
1.
NAME OF THE MEDICINAL PRODUCT
Hexaxim suspension for injection in pre-filled syringe
Hexaxim suspension for injection
Diphtheria, tetanus, pertussis (acellular, component), hepatitis B
(rDNA), poliomyelitis (inactivated)
and _Haemophilus influenzae_ type b conjugate vaccine (adsorbed).
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose
1
(0.5 ml) contains:
Diphtheria Toxoid
not less than 20 IU
2
Tetanus Toxoid
not less than 40 IU
2
_Bordetella_ _pertussis_ antigens
Pertussis Toxoid
25 micrograms
Filamentous Haemagglutinin
25 micrograms
Poliovirus (Inactivated)
3
Type 1 (Mahoney)
40 D antigen units
4
Type 2 (MEF-1)
8 D antigen units
4
Type 3 (Saukett)
32 D antigen units
4
Hepatitis B surface antigen
5
10 micrograms
_Haemophilus influenzae_ type b polysaccharide
12 micrograms
(Polyribosylribitol Phosphate)
conjugated to Tetanus protein
22-36 micrograms
1
Adsorbed on aluminium hydroxide, hydrated (0.6 mg Al
3+
)
2
As lower confidence limit (p= 0.95)
3
Produced on Vero cells
4
Or equivalent antigenic quantity determined by a suitable
immunochemical method
5
Produced in yeast_ Hansenula polymorpha _cells by recombinant DNA
technology
The vaccine may contain traces of glutaraldehyde, formaldehyde,
neomycin, streptomycin and
polymyxin B which are used during the manufacturing process (see
section 4.3).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection.
Hexaxim is a whitish, cloudy suspension.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hexaxim (DTaP-IPV-HB-Hib) is indicated for primary and booster
vaccination of infants and toddlers
from six weeks of age against diphtheria, tetanus, pertussis,
hepatitis B, poliomyelitis and invasive
diseases caused by _Haemophilus influenzae_ type b (Hib).
The use of this vaccine should be in accordance with o