Hexacima
Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Fuljett ta 'informazzjoni
(PIL)
23-06-2023
Karatteristiċi tal-prodott
(SPC)
23-06-2023
Rapport ta 'Valutazzjoni Pubblika
(PAR)
12-07-2016
Ingredjent attiv:
hepatitis B surface antigen, Diphtheria toxoid, tetanus toxoid, Bordetella pertussis antigens Pertussis Toxoid Filamentous Haemagglutinin, poliovirus (inactivated) type 1 (Mahoney) type 2 (MEF-1) type 3 (Saukett), Haemophilus influenzae type b polysaccharide (Polyribosylribitol Phosphate) conjugated to Tetanus protein
Disponibbli minn:
Sanofi Pasteur
Kodiċi ATC:
J07CA09
INN (Isem Internazzjonali):
diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus influenzae type b conjugate vaccine (adsorbed)
Grupp terapewtiku:
Vaccines, Bacterial and viral vaccines, combined
Żona terapewtika:
Hepatitis B; Tetanus; Immunization; Meningitis, Haemophilus; Whooping Cough; Poliomyelitis; Diphtheria
Indikazzjonijiet terapewtiċi:
Hexacima (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 official recommendations.
Sommarju tal-prodott:
Revision: 29
L-istatus ta 'awtorizzazzjoni:
Authorised
Data ta 'l-awtorizzazzjoni:
2013-04-17
Fuljett ta 'informazzjoni
31
B. PACKAGE LEAFLET
32
PACKAGE LEAFLET: INFORMATION FOR THE USER
HEXACIMA 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 Hexacima is and what it is used for
2.
What you need to know before Hexacima is given to your child
3.
How Hexacima is given
4.
Possible side effects
5.
How to store Hexacima
6.
Contents of the pack and other information
1.
WHAT HEXACIMA IS AND WHAT IT IS USED FOR
Hexacima (DTaP-IPV-HB-Hib) is a vaccine used to protect against
infectious diseases.
Hexacima helps to protect against diphtheria, tetanus, pertussis,
hepatitis B, poliomyelitis and serious
diseases caused by
_Haemophilus influenzae_
type b. Hexacima 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
Aqra d-dokument sħiħ
Karatteristiċi tal-prodott
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Hexacima suspension for injection in pre-filled syringe
Hexacima 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)
29 D-antigen units
6
Type 2 (MEF-1)
7 D-antigen units
6
Type 3 (Saukett)
26 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
Cultivated on Vero cells
6
These antigen quantities are strictly the same as those previously
expressed as 40-8-32 D-antigen
units, for virus type 1, 2 and 3 respectively, when measured by
another 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.
Hexacima is a whitish, cloudy suspension.
3
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hexacima (DTaP-IPV-HB-Hib) is indicated for primary and booster
vaccination of infants and
toddlers from
Aqra d-dokument sħiħ
