INFANRIX IPV HIB

Země: Izrael

Jazyk: angličtina

Zdroj: Ministry of Health

Aktivní složka:

DIPHTHERIA TOXOID; FILLAMENTOUS HAEMAGGLUTININ (FHA); HAEMOPHILUS INFLUENZAE TYPE B POLYSACCHARIDE; INACTIVATED POLIO VIRUS (IPV) TYPE 1; INACTIVATED POLIO VIRUS (IPV) TYPE 2; INACTIVATED POLIO VIRUS (IPV) TYPE 3; PERTACTIN; PERTUSSIS TOXOID (PT); TETANUS TOXOID

Dostupné s:

GLAXO SMITH KLINE (ISRAEL) LTD

ATC kód:

J07CA06

Léková forma:

POWDER AND SUSPENSION FOR SUSPENSION FOR INJECTION

Složení:

DIPHTHERIA TOXOID NLT 60 IU/ML; INACTIVATED POLIO VIRUS (IPV) TYPE 3 64 DU / 1 ML; INACTIVATED POLIO VIRUS (IPV) TYPE 2 16 DU / 1 ML; INACTIVATED POLIO VIRUS (IPV) TYPE 1 80 DU / 1 ML; PERTUSSIS TOXOID (PT) 50 MCG/ML; FILLAMENTOUS HAEMAGGLUTININ (FHA) 50 MCG/ML; PERTACTIN 16 MCG/ML; TETANUS TOXOID NLT 80 IU/ML; HAEMOPHILUS INFLUENZAE TYPE B POLYSACCHARIDE 20 MCG/VIAL

Podání:

I.M

Druh předpisu:

Required

Výrobce:

GLAXO SMITH KLINE BIOLOGICALS S.A

Terapeutické skupiny:

DIPHTHERIA-HEMOPHILUS INFLUENZAE B-PERTUSSIS-POLIOMYELITIS-TETANUS

Terapeutické oblasti:

DIPHTHERIA-HEMOPHILUS INFLUENZAE B-PERTUSSIS-POLIOMYELITIS-TETANUS

Terapeutické indikace:

Active immunisation in infants from the age of 2 months to 5 years against diptheria, tetanus, pertussis, poliomyelitis and Haemophilus influenza type b. Booster dose for children who have previously been immunised with DTP, Polio and Hib antigens

Datum autorizace:

2023-09-30

Informace pro uživatele

Patient leaflet in accordance with the Pharmacists' Regulations
(Preparations)
- 1986
This medicine is dispensed with a doctor’s prescription only
Infanrix IPV-Hib
Powder and suspension for suspension for injection
Each dose (0.5 ml) contains:
diphtheria toxoid
– NLT 30 IU
tetanus toxoid (T)
– NLT 40 IU
pertussis toxoid (PT)
– 25 mcg
filamentous hemagglutinin (FHA)
– 25 mcg
pertactin (PRN)
– 8 mcg
inactivated Polio Virus type 1
– 40 DU
inactivated Polio Virus type 2
– 8 DU
inactivated Polio Virus type 3
– 32 DU
Haemophilus influenzae type b
polysaccharide (PRP)
– 10 mcg
conjugated to tetanus toxoid as
carrier protein
– approximately 25 mcg
For the list of the inactive and allergenic ingredients in the
medicine, see section
2 – “Important information about some of the ingredients in the
medicine” and
section 6 – “Additional information”.
Read the entire leaflet carefully before you start using this
medicine. This leaflet
contains concise information about this medicine. If you have any
further
questions, consult your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may
harm them, even if it seems to you that their medical condition is
similar to
yours.
1. What is this medicine intended for?
Active immunisation in infants from the age of 2 months to 5 years
against
diptheria, tetanus, pertussis, poliomyelitis and Haemophilus influenza
type b.
Booster dose for children who have previously been immunised with DTP,
Polio and Hib antigens.
Therapeutic group: Bacterial and viral vaccines combined
How the vaccine works?
This vaccine helps your child’s body make its own protection
(antibodies).
This will protect your child against these diseases.
Infanrix-IPV-Hib will only protect against infections caused by the
pathogens
for which the vaccine has been developed.
As with all vaccines, Infanrix-IPV-Hib may not fully protect all
children who are
vaccinated.
Children with a weakened immune system (such as due to HIV infection)
may
not get th

Charakteristika produktu

Page 1 of 9
INFANRIX IPV HIB
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 formaldehyde, neomycin and polymyxin
which are used during the
manufacturing process (see section 4.3).
Excipients with known effect
The vaccine contains para-aminobenzoic acid < 0.07 nanograms per dose
and phenylalanine 0.036
micrograms per dose (see section 4.4).
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
Page 2 of 9
INFANRIX- IPV+Hib is indicated for active immunisation in infants from
the age of 2 months to 5
years
,
against diphtheria, tetanus, pertussis, poliomyelitis and
_Haemophilus influenzae_
type b.
INFANRIX- IPV +Hib is also indicated as a booster dose for children
who have previously been
im