Infanrix-IPV + Hib vaccine powder and suspension for suspension for injection 0.5ml pre-filled syringes

País: Reino Unido

Língua: inglês

Origem: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes ativos:

Diphtheria toxoid; Tetanus toxoid; Pertussis antigens; Human poliovirus type 1 inactivated; Human poliovirus type 2 inactivated; Human poliovirus type 3 inactivated; Haemophilus influenzae type b polysaccharide protein conjugate

Disponível em:

GlaxoSmithKline UK Ltd

Código ATC:

J07CA06

DCI (Denominação Comum Internacional):

Diphtheria toxoid; Tetanus toxoid; Pertussis antigens; Human poliovirus type 1 inactivated; Human poliovirus type 2 inactivated; Human poliovirus type 3 inactivated; Haemophilus influenzae type b polysaccharide protein conjugate

Forma farmacêutica:

Powder and suspension for suspension for injection

Via de administração:

Intramuscular

Classe:

No Controlled Drug Status

Tipo de prescrição:

Valid as a prescribable product

Resumo do produto:

BNF: 14040000; GTIN: 5000483760205

Folheto informativo - Bula

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 with

Características técnicas

OBJECT 1
INFANRIX-IPV+HIB POWDER AND SUSPENSION FOR
SUSPENSION FOR INJECTION
Summary of Product Characteristics Updated 06-Feb-2018 |
GlaxoSmithKline UK
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
2
Propagated in VERO cells
0.5 milligrams Al
3+
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 wit