Pentavac Diphtheria, tetanus, pertussis (acellular, component), poliomyelitis (inactivated) and Haemophilus influenzae type b co

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Purified Diphtheria Toxoid Ph. Eur.; Purified tetanus toxoid; Adsorbed purified pertussis toxoid; Adsorbed purified filamentous haemagglutinin; Inactivated Poliomyelitis Virus Ph. Eur; Inactivated type 1 poliovirus; Inactivated type 2 poliovirus; Inactivated type 3 poliovirus; Haemophilus influenzae type b, conjugate with tetanus protein

Available from:

Sanofi Pasteur

ATC code:

J07CA06

INN (International Name):

Purified Diphtheria Toxoid Ph. Eur.; Purified tetanus toxoid; Adsorbed purified pertussis toxoid; Adsorbed purified filamentous haemagglutinin; Inactivated Poliomyelitis Virus Ph. Eur; Inactivated type 1 poliovirus; Inactivated type 2 poliovirus; Inactivated type 3 poliovirus; Haemophilus influenzae type b, conjugate with tetanus protein

Dosage:

0.5 millilitre(s)

Pharmaceutical form:

Powder for suspension for injection

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

diphtheria-hemophilus influenzae B-pertussis-poliomyelitis-tetanus

Authorization status:

Not marketed

Authorization date:

2001-03-23

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
PENTAVAC, POWDER AND SUSPENSION FOR INJECTION
DIPHTHERIA, TETANUS, PERTUSSIS (ACELLULAR, COMPONENT), 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.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, nurse or
pharmacist.
-
This medicine has been prescribed only for your child. Do not pass it
on to others.
-
If your child gets any side effects, talk to your doctor, nurse or
pharmacist. This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Pentavac is and what it is used for
2.
What you need to know before Pentavac is given to your child
3.
How to use Pentavac
4.
Possible side effects
5.
How to store Pentavac
6.
Contents of the pack and other information
1.
WHAT PENTAVAC IS AND WHAT IT IS USED FOR
Pentavac is a vaccine. Vaccines are used to protect against infectious
diseases.
This vaccine helps to protect your child against diphtheria, tetanus,
pertussis (whooping cough),
poliomyelitis (polio) and serious diseases caused by
_Haemophilus influenzae _
type b (often just called
Hib infections).
It is given as a primary series vaccination in babies and as a booster
vaccination in children who
received this vaccine or a similar vaccine when they were younger.
When an injection of Pentavac is given, the body’s natural defences
will produce protection against
these different diseases.

Diphtheria is an infectious disease that usually first affects the
throat. In the throat, the infection
causes pain and swelling which can lead to suffocation. The bacteria
that cause the disease also
produce a toxin (poison) that can damage the heart, kidneys and
nerves.

Tetanus (often called lock jaw) is caused by the tetanus bacteria
entering a deep wound. The
bacteria produce a toxin (poison) that causes spasms of the m

Summary of Product characteristics

Health Products Regulatory Authority
22 November 2018
CRN008RDN
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pentavac Diphtheria, tetanus, pertussis (acellular, component),
poliomyelitis
(inactivated) and Haemophilus influenzae type b conjugate vaccine
(adsorbed)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 0.5 mL dose of reconstituted vaccine contains:
Purified diphtheria toxoid
1
....................................................... not less than
30 I.U. #
Purified tetanus toxoid
1
........................................................... not less
than 40 I.U.*
Purified pertussis toxoid (PTxd)
1
............................................ 25 µg
Purified filamentous haemagglutinin (FHA)
1
............................ 25 µg
Inactivated type 1 poliovirus
2
................................................. D antigen**: 40
units
Inactivated type 2 poliovirus
2
................................................. D antigen**: 8 units
Inactivated type 3 poliovirus
2
................................................. D antigen**: 32
units
_Haemophilus influenzae_ type b polysaccharide..................... 10
µg
conjugated to tetanus protein
# As mean value
* As lower confidence limit (p = 0.95).
** Quantity of antigen in the final bulk product.
1
adsorbed on aluminium hydroxide (expressed as Al
3+
) 0.30 mg
2
produced on Vero cells
Pentavac solution for injection is obtained by reconstitution of the
powder of
conjugate _Haemophilus influenzae_ type b vaccine (vial) with the
suspension of
combined diphtheria, tetanus, acellular pertussis and inactivated
poliomyelitis
vaccine, adsorbed (pre-filled syringe).
The vaccine may contain traces of glutaraldehyde, neomycin,
streptomycin and
polymyxin B (see section 4.4).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder and suspension for injection.
Pentavac is composed of a sterile and whitish turbid suspension and a
white and
homogenous powder.
Health Products Regulatory Authority
22 November 2018
CRN008RDN