Hexaxim suspension for injection

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

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

Available from:

Sanofi Pasteur

ATC code:

J07CA09

INN (International Name):

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

Dosage:

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

Pharmaceutical form:

suspension for injection

Units in package:

pre-filled syringe 0,5ml and (2) needles

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2021-02-27

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
HEXAXIM SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE
Diphtheria, tetanus, pertussis (acellular, component), hepatitis B
(rDNA), poliomyelitis (inactivated)
and _Haemophilus influenzae_ type b conjugate vaccine (adsorbed)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOUR CHILD IS VACCINATED
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR HIM/HER.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, pharmacist or
nurse.

If your child gets any side effects, talk to your doctor, pharmacist
or nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Hexaxim is and what it is used for
2.
What you need to know before Hexaxim is given to your child
3.
How to use Hexaxim
4.
Possible side effects
5.
How to store Hexaxim
6.
Contents of the pack and other information
1.
WHAT HEXAXIM IS AND WHAT IT IS USED FOR
Hexaxim (DTaP-IPV-HB-Hib) is a vaccine used to protect against
infectious diseases.
Hexaxim helps to protect against diphtheria, tetanus, pertussis,
hepatitis B, poliomyelitis and serious
diseases caused by _Haemophilus influenzae_ type b. Hexaxim is given
to children from six weeks of
age.
The vaccine works by causing the body to produce its own protection
(antibodies) against the bacteria
and viruses that cause these different infections:

Diphtheria is an infectious disease that usually first affects the
throat. In the throat, the
infection causes pain and swelling that can lead to suffocation. The
bacterium that causes the
disease also makes a toxin (poison) that can damage the heart,
kidneys, and nerves.

Tetanus (often called lock jaw) is usually caused by the tetanus
bacterium entering a deep
wound. The bacterium makes a toxin (poison) that causes spasms of the
muscles leading to
inability to breathe and the possibility of suffocation.

Pertussis (often called whooping cough) is a highly infectious illness
that affects the airways.
It causes

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
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
2,4
(30 Lf)
Tetanus Toxoid
not less than 40 IU
3,4
(10 Lf)
_Bordetella_ _pertussis_ antigens
Pertussis Toxoid
25 micrograms
Filamentous Haemagglutinin
25 micrograms
Poliovirus (Inactivated)
5
Type 1 (Mahoney)
40 D-antigen units
6
Type 2 (MEF-1)
8 D-antigen units
6
Type 3 (Saukett)
32 D-antigen units
6
Hepatitis B surface antigen
7
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) and not less than 30 IU as mean
value
3
As lower confidence limit (p= 0.95)
4
Or equivalent activity determined by an immunogenicity evaluation
5
Produced on Vero cells
6
Or equivalent antigenic quantity determined by a suitable
immunochemical method
7
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).
Excipient with known effect
Phenylalanine……………85 micrograms
(See section 4.4)
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_ ty