INFANRIX HEXA

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

DIPHTHERIA TOXOID; FILAMENTOUS HAEMAGGLUTININ (FHA); HAEMOPHILUS B; HEPATITIS B VACCINES; PERTACTIN; PERTUSSIS TOXOID (PT); POLIOVIRUS TYPE 1 INACTIVATED; POLIOVIRUS TYPE 2 INACTIVATED; POLIOVIRUS TYPE 3 INACTIVATED; TETANUS TOXOID

Available from:

GLAXO SMITH KLINE (ISRAEL) LTD

ATC code:

J07CA

Pharmaceutical form:

POWDER AND SUSPENSION FOR SUSPENSION FOR INJECTION

Composition:

FILAMENTOUS HAEMAGGLUTININ (FHA) 25 MCG/DOSE; DIPHTHERIA TOXOID NLT 30 IU/DOSE; TETANUS TOXOID NLT 40 IU/DOSE; HEPATITIS B VACCINES 10 MCG/DOSE; POLIOVIRUS TYPE 1 INACTIVATED 40 DU/DOSE; POLIOVIRUS TYPE 2 INACTIVATED 8 DU/DOSE; POLIOVIRUS TYPE 3 INACTIVATED 32 DU/DOSE; HAEMOPHILUS B 10 MCG/DOSE; PERTACTIN 8 MCG/DOSE; PERTUSSIS TOXOID (PT) 25 MCG/DOSE

Administration route:

I.M

Prescription type:

Required

Manufactured by:

GLAXO SMITH KLINE BIOLOGICALS S.A

Therapeutic group:

BACTERIAL AND VIRAL VACCINES, COMBINED

Therapeutic indications:

Infantix hexa is indicated for primary and booster vaccination of infants against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and disease caused by haemophilus influenza type b for infants between 6 weeks and 36 months of age.

Authorization date:

2020-07-31

Patient Information leaflet

ךיראת
4102
-
00
תילגנאב רישכת םש
םושירה רפסמו
:
30676)
-
20
-
INFANRIX HEXA (REG. NO.:133
םושירה לעב םש
:
GLAXOSMITHKLINE (ISRAEL) LTD
! דבלב תורמחהה טורפל דעוימ הז ספוט
שקובמה תורמחהה
תו
ןולעב קרפ
יחכונ טסקט
שדח טסקט
SPECIAL WARNINGS
AND SPECIAL
PRECAUTIONS FOR USE
---------------------
…
As for any vaccination, the risk-
benefit of immunising with Infanrix
hexa or deferring this vaccination
should be weighed carefully in an
infant or in a child suffering from a
new onset or progression of a severe
neurological disorder.
…
The physician should be aware
that the rate of febrile reactions is
higher when Infanrix hexa is co-
administered with a
pneumococcal conjugate vaccine
(PCV7, PCV10, PCV13), or with
a measles-mumps-rubella-
varicella (MMRV) vaccine,
compared to that occurring
following the administration of
Infanrix hexa alone. These
reactions were mostly moderate
(less than or equal to 39°C) and
transient (see sections 4.5 and
4.8).
Increased reporting rates of
convulsions (with or without
fever) and hypotonic
hyporesponsive episode (HHE)
were observed with concomitant
administration of Infanrix hexa
and Prevenar 13 (see section 4.8).
INTERACTION WITH
OTHER MEDICINAL
PRODUCTS AND OTHER
FORMS OF INTERACTION
There are insufficient data with
regard to the efficacy and safety
of simultaneous administration
of Infanrix hexa and Measles-
Mumps-Rubella vaccine to
allow any recommendation to be
made.
Data on concomitant
administration of Infanrix hexa
with Prevenar (pneumococcal
saccharide conjugated vaccine,
Infanrix hexa can be given
concomitantly with pneumococcal
conjugate vaccine (PCV7, PCV10
and PCV13), meningococcal
serogroup C conjugate vaccine
(CRM
197
and TT conjugates),
meningococcal serogroups A, C, W-
135 and Y conjugate vaccine (TT
conjugate), oral rotavirus vaccine and
measles-mumps-rubella-varicella
(MMRV) vaccine.
adsorbed) have shown no
clinically relevant interference
in the antibody resp

Summary of Product characteristics

Page 1 of 14
INFANRIX HEXA
1.
Name of the Medicinal Product
Infanrix hexa, Powder and suspension for suspension for injection in a
pre-filled syringe.
Diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa),
hepatitis B (rDNA) (HBV),
poliomyelitis (inactivated) (IPV) and Haemophilus influenzae type b
(Hib) conjugate vaccine
(adsorbed).
2.
Qualitative And Quantitative Composition
After reconstitution, 1 dose (0.5 ml) contains:
Pertussis toxoid, adsorbed (PT)
25 µg
Filamentous haemagglutinin, adsorbed (FHA)
25 µg
Pertactin (69kDa Outer Membrane Protein – PRN)
8 µg
Diphtheria toxoid, adsorbed (D)
Not less than 30 IU
Tetanus toxoid, adsorbed (T)
Not less than 40 IU
rDNA Hepatitis B surface antigen (HbsAg)
10 µg
Inactivated Polio Virus (IPV) Type 1
40 DU
Inactivated Polio Virus (IPV) Type 2
8 DU
Inactivated Polio Virus (IPV) Type 3
32 DU
Conjugate of Haemophilus influenzae type b capsular
polysaccharide (PRP) and Tetanus toxoid.
10 µg of PRP and
~ 25 µg T
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 0.057 nanograms per dose
and phenylalanine
0.0298 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 in a pre-filled
syringe.
The diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated
poliomyelitis (DTPa-
HBV-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 hexa is indicated for primary and booster vaccination of
infants against diphtheria,
tetanus, pertussis, hepatitis B, poliomyelitis and disease caused by
Haemophilus influenzae
type b for infants between 6 weeks and 36 months of age.
Page 2 of 14
4.2
Posology and method of administration
_Posology _
The immunisation schedules for