Vaxelis

Land: Europeiska unionen

Språk: engelska

Källa: EMA (European Medicines Agency)

Aktiva substanser:

Diphtheria toxoid, tetanus toxoid, Bordetella pertussis antigens: pertussis toxoid, filamentous haemagglutinin, pertactin, fimbriae Types 2 and 3, hepatitis B surface antigen produced in yeast cells, poliovirus (inactivated): type 1 (Mahoney), type 2 (MEF-1), type 3 (Saukett) produced in Vero cells/ Haemophilus influenzae type b polysaccharide (polyribosylribitol phosphate) conjugated to meningococcal protein.

Tillgänglig från:

MCM Vaccine B.V.

ATC-kod:

J07CA09

INN (International namn):

diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and Haemophilus type b conjugate vaccine (adsorbed)

Terapeutisk grupp:

Vaccines

Terapiområde:

Meningitis, Haemophilus; Poliomyelitis; Tetanus; Diphtheria; Whooping Cough; Hepatitis B

Terapeutiska indikationer:

Vaxelis (DTaP-HB-IPV-Hib) is indicated for primary and booster vaccination in infants and toddlers from the age of 6 weeks, against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases caused by Haemophilus influenzae type b (Hib). The use of Vaxelis should be in accordance with official recommendations.

Produktsammanfattning:

Revision: 14

Bemyndigande status:

Authorised

Tillstånd datum:

2016-02-15

Bipacksedel

31
B. PACKAGE LEAFLET
32
PACKAGE LEAFLET: INFORMATION FOR THE
USER
VAXELIS SUSPENSION FOR INJECTION IN PRE-FILLED
SYRINGE
Diphtheria, tetanus, pertussis (acellular, component), hepatitis B
(rDNA), polio
myelitis (
inactivated),
and
Haemophilus
type b
conjugate
vaccine (adsorbed).
READ ALL OF THIS LEAFLET CAREFULLY BEFORE
YOUR CHILD IS
VACCINATED WITH
THIS MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have a
ny further questions, ask your
doctor, pharmacist or nurse.
•
This medicine has been prescribed for you
r child
only. Do not pass it on to others.
•
If your child
get 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 Vaxelis
is and what it
is used for
2.
What you need to know before
Vaxelis
is given to your child
3.
How to use Vaxelis
4.
Possible side effects
5.
How to store Vaxelis
6.
Contents of the pack and other information
1.
WHAT IS VAXELIS
AND WHAT IT IS USED FOR
Vaxelis is a vaccine,
which helps
to protect your child against
diphtheria, tetanus, pertussis, hepatitis
B, poliomyelitis and serious diseases caused by
Haemophilus influenzae
type b. Vaxelis is given to
children
from the
age of six weeks.
The vaccine works by causing the body to produce its own protection
(antibodies)
against the bacteria
and viruses that cause the
following diseases
:
•
Diphtheria:
a bacterial infection
that usually first affects the throat
, causing
pain and swelling
which can lead to suffocation. The bacteria also make a toxin (poison)
that can damage the
heart, kidneys and nerves.
•
Tetanus (often called lock jaw)
:
caused by the tetanus bacteria entering a deep wound.
The
bacteria make a toxin (poiso
n) that causes spasms of the muscles, leading to inability to breathe
and the possibility of suffocation.
•
Pertussis (often called whooping cough)
:
a highly infectious illness that affects the airways. It
causes

Produktens egenskaper

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Vaxelis suspension for injection
in pre-
filled syringe
Vaxelis suspension for injection
Diphtheria, tetanus, pertussis (acellular, component), hepatitis B
(rDNA), polio
myelitis (
inactivated),
and
Haemophilus
type b
conjugate
vaccine
(adsorbed).
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose (0.5 mL) contains:
Diphtheria Toxoid
1
not less than 20
IU
6
Tetanus Toxoid
1
not less than 40
IU
6
Bordetella pertussis
antigens
1
Pertussis Toxoid (PT)
20
micrograms
Filamentous Haemagglutinin (FHA)
20
micrograms
Pertactin (PRN)
3 micrograms
Fimbriae Types 2 and 3 (FIM)
5 micrograms
Hepatitis B surface antigen
2,3
10 micrograms
Poliovirus (Inactivated)
4
Type 1 (Mahoney)
40
D antigen units
5
Type 2 (MEF
-1)
8
D antigen units
5
Type 3 (Saukett)
32
D antigen units
5
Haemophilus influenzae
type b polysaccharide
(Polyribosylribitol Phosphate)
3 micrograms
Conjugated to meningococcal protein
2
50
micrograms
1
adsorbed on aluminium phosphate (0.17
mg Al
3+
)
2
adsorbed on amorphous aluminium hydroxyphosphate sulfate (0.15
mg Al
3+
)
3
produced in yeast (
Saccharomyces cerevisiae
) cells by recombinant DNA technology
4
produced
in Vero cells
5
or equivalent antigenic quantity determined by a suitable
immunochemical method
6
or equivalent activity determined by an immunogenicity evaluation
.
The vaccine may contain traces of glutaraldehyde, formaldehyde,
neomycin, streptomycin, polymyxin
B,
and bovine serum albumin
which are used during the m
anufacturing
process (see section 4.3).
For the full list of excipients, see section
6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection
(injection).
U
niform, cloudy, white to off
-white
suspension.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Vaxelis (DTaP-HB-IPV-
Hib) is indicated for primary
a
nd booster vaccination
in infants and toddlers
from the age of 6 weeks
,
against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and
invasive
diseases caused by
Haemophilus influenzae
type b (Hi