INFANRIX-IPV+Hib powder and suspension for suspension for injection. Diphtheria, tetanus, pertussis (acellular component), polio

Country: Малта

Језик: Енглески

Извор: Medicines Authority

Активни састојак:

PERTACTIN; PERTUSSIS FILAMENTOUS HAEMAGGLUTININ; PERTUSSIS TOXOID; POLIOVIRUS (INACTIVATED) TYPE 1 (MAHONEY STRAIN); POLIOVIRUS (INACTIVATED) TYPE 2 (MEF-1 STRAIN); POLIOVIRUS (INACTIVATED) TYPE 3 (SAUKETT STRAIN); DIPHTHERIA TOXOID; HAEMOPHILUS INFLUENZAE TYPE B POLYSACCHARIDE (POLYRIBOSYLRIBITOL PHOSPHATE); TETANUS TOXOID

Доступно од:

Smithkline Beecham Limited

АТЦ код:

J07CA06

INN (Међународно име):

PERTACTIN; PERTUSSIS FILAMENTOUS HAEMAGGLUTININ; PERTUSSIS TOXOID; POLIOVIRUS (INACTIVATED) TYPE 1 (MAHONEY STRAIN); POLIOVIRUS

Фармацеутски облик:

POWDER AND SUSPENSION FOR SUSPENSION FOR INJECTION

Састав:

PERTACTIN 8 µg; PERTUSSIS FILAMENTOUS HAEMAGGLUTININ 25 µg; PERTUSSIS TOXOID 25 µg; POLIOVIRUS (INACTIVATED) TYPE 1 (MAHONEY STRAIN) 40 DAgU/0.5ml; POLIOVIRUS (INACTIVATED) TYPE 2 (MEF-1 STRAIN) 8 DAgU/0.5ml; POLIOVIRUS (INACTIVATED) TYPE 3 (SAUKETT STRAIN) 32 DAgU/0.5ml; DIPHTHERIA TOXOID; HAEMOPHILUS INFLUENZAE TYPE B POLYSACCHARIDE (POLYRIBOSYLRIBITOL PHOSPHATE) 10 µg; TETANUS TOXOID

Тип рецептора:

POM

Терапеутска област:

VACCINES

Статус ауторизације:

Authorised

Датум одобрења:

2006-03-09

Информативни летак

I PACKAGE LEAFLET: INFORMATION FOR THE USER
INFANRIX-IPV+HIB VACCINE
POWDER AND SUSPENSION FOR SUSPENSION FOR INJECTION
Diphtheria (D), tetanus (T), pertussis (acellular component) (Pa),
poliomyelitis (inactivated)
(IPV) and _Haemophilus influenzae _type b (Hib) conjugate vaccine
(adsorbed)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOUR CHILD STARTS RECEIVING
THIS VACCINE BECAUSE
IT CONTAINS IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This vaccine has been prescribed for your child only. Do not pass it
on to others.

If your child gets any side effects, talk to your doctor or
pharmacist. This includes any
possible side effects not listed in this leaflet.
See section 4.
WHAT IS IN THIS LEAFLET
1.
What Infanrix-IPV+Hib is and what it is used for
2.
What you need to know before your child receives Infanrix-IPV+Hib
3.
How Infanrix-IPV+Hib is given
4.
Possible side effects
5. How to store Infanrix-IPV+Hib
6.
Contents of the pack and other information
1.
WHAT INFANRIX-IPV+HIB IS AND WHAT IT IS USED FOR
Infanrix-IPV+Hib is a vaccine used to protect your child against 5
diseases:

DIPHTHERIA - a serious bacterial infection that mainly affects the
airways and sometimes
the skin. The airways become swollen causing serious breathing
problems. The bacteria
also release a poison. This can cause nerve damage, heart problems and
even death.

TETANUS - Tetanus bacteria enter the body through cuts, scratches or
wounds in the
skin. Wounds that are more likely to get tetanus infection are burns,
fractures, deep
wounds or wounds that have soil, dust, horse manure or wood splinters
in them. The
bacteria release a poison. This can cause muscle stiffness, painful
muscle spasms, fits
and even death. The muscle spasms can be strong enough to cause bone
fractures of
the spine.

WHOOPING COUGH (PERTUSSIS) - a highly infectious disease that affects
the airways. It
causes severe coughing that may lead to problems wit

Карактеристике производа

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
INFANRIX-IPV+Hib powder and suspension for suspension for injection
Diphtheria (D) , tetanus (T) , pertussis (acellular component) (Pa) ,
poliomyelitis (inactivated) (IPV)
and _Haemophilus influenzae _type b (Hib) conjugate vaccine (adsorbed)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
A 0.5 ml dose of vaccine contains:
Diphtheria toxoid
1
not less than 30 International Units (IU) (25 Lf)
Tetanus toxoid
1
not less than 40 International Units (IU) (10 Lf)
_Bordetella pertussis_ antigens
Pertussis toxoid (PT)
1
25 µg
Filamentous haemagglutinin (FHA)
1
25 µg
Pertactin (PRN)
1
8 µg
Poliovirus (inactivated) (IPV)
type 1 (Mahoney strain)
2
40 D-antigen unit
type 2 (MEF-1 strain)
2
8 D-antigen unit
type 3 (Saukett strain)
2
32 D-antigen unit
_Haemophilus influenzae_ type b polysaccharide
(polyribosylribitol phosphate) (PRP)
10 µg
conjugated to tetanus toxoid as carrier protein
approximately 25 µg
1
Adsorbed on aluminium hydroxide, hydrated
0.5 milligrams Al
3+
2
Propagated in VERO cells
The vaccine may contain traces of neomycin, polymyxin and polysorbate
80 which
are used during the manufacturing process (see section 4.3).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and suspension for suspension for injection.
The diphtheria, tetanus, acellular pertussis and inactivated
poliomyelitis (DTPa-IPV) component is a
turbid white suspension.
The lyophilised _Haemophilus influenzae_ type b (Hib) component is a
white powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
INFANRIX-IPV+Hib is indicated for active immunisation against
diphtheria, tetanus, pertussis,
poliomyelitis and _Haemophilus influenzae_ type b disease from the age
of 2 months.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_Primary vaccination: _
The primary vaccination schedule consists of two or three doses given
in accordance with official
recommendations. The minimum age at the time of the first dose is 2
months. Subsequent doses of the
pri