INFANRIX-IPV+Hib powder and suspension for suspension for injection. Diphtheria, tetanus, pertussis (acellular component), poliomyelitis (inactivated) and Haemophilus type b conjugate vaccine (adsorbed)
Country: Малта
Језик: Енглески
Извор: Medicines Authority
Информативни летак
(PIL)
27-06-2023
Карактеристике производа
(SPC)
27-06-2023
Активни састојак:
PERTACTIN, PERTUSSIS FILAMENTOUS, HAEMAGGLUTININ, PERTUSSIS TOXOID, POLIOVIRUS, INACTIVATED, TYPE, MAHONEY STRAIN, MEF, SAUKETT STRAIN, DIPHTHERIA TOXOID, HAEMOPHILUS INFLUENZAE, TYPE B, POLYSACCHARIDE, POLYRIBOSYLRIBITOL PHOSPHATE, TETANUS TOXOID
Доступно од:
GlaxoSmithKline Biologicals S.A. Rue de L'Institut 89 B-1330 Rixensart, Belgium
АТЦ код:
J07CA06
INN (Међународно име):
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
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:
Withdrawn
Датум одобрења:
2006-03-09
Информативни летак
PACKAGE LEAFLET
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 lea
Прочитајте комплетан документ
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
pr
Прочитајте комплетан документ
