PENTAXIM

Negara: Indonesia

Bahasa: Bahasa Indonesia

Sumber: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Bahan aktif:

DIPHTHERIA AND TETANUS TOXOIDS; FHA; FILAMENTOUS HEMAGGLUTININ; HAEMOPHILUS INFLUENZAE TYPE B POLYSACCHARIDE

Tersedia dari:

AVENTIS PHARMA - Indonesia

INN (Nama Internasional):

DIPHTHERIA AND TETANUS TOXOIDS; FHA; FILAMENTOUS HEMAGGLUTININ; HAEMOPHILUS INFLUENZAE TYPE B POLYSACCHARIDE

Bentuk farmasi:

SERBUK INJEKSI

Unit dalam paket:

DUS, 1 VIAL + 1 PREFILLED SYRINGE @ 0.5 mL DENGAN 2 JARUM TERPIS...

Diproduksi oleh:

SANOFI PASTEUR - France

Tanggal Otorisasi:

2018-12-31

Karakteristik produk

SP/XXXXXX
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PENTAXIM
DIPHTHERIA, TETANUS PERTUSSIS (ACELLULAR,
COMPONENT), POLIOMYELITIS (INACTIVATED) VACCINE
AND HAEMOPHILUS TYPE B CONJUGATE VACCINE,
ADSORBED
Powder
and
suspension
for
suspension
for
injection
in
pre-filled syringe
QUALITATIVE AND QUANTITATIVE COMPOSITION
After reconstitution one dose (0.5 mL) contains:
Diphtheria toxoid
(1)
..........................................................≥ 30 IU
(2) (3)
Tetanus toxoid
(1)
...............................................................≥ 40
IU
(3) (4)
Bordetella pertussis antigens:
Pertussis toxoid
(1)
......................................................25 micrograms
Filamentous haemagglutinin
(1)
................................25 micrograms
Poliomyelitis virus (inactivated)
-type 1 (Mahoney strain)
(5)
........................................40 DU
(6)(7)
-type 2 (MEF-1 strain)
(5)
..............................................8 DU
(6)(7)
-type 3 (Saukett strain)
(5)
...........................................32 DU
(6)(7)
Polysaccharide of Haemophilus influenzae type b...10 micrograms
conjugated to the tetanus protein.......................18-30
micrograms
(1)
Adsorbed on aluminium hydroxide, hydrated............0.3 mg Al
3+
(2)
As mean value
(3)
Or
equivalent
activity
determined
by
an
immunogenicity
evaluation
(4)
As lower confidence limit (p=0.95)
(5)
Produced on VERO cells.
(6)
DU: D antigen unit.
(7)
Or
equivalent
antigenic
quantity
determined
by
a
suitable
immunochemical method.
PENTAXIM
may
contain
traces
of
glutaraldehyde,
neomycin,
streptomycin and polymyxin B (see Section “Contraindications”).
Excipient(s) with known effect:
Phenylalanine..................................……….…....12.5
micrograms
(see section “Special warnings and precautions for use”)
For a full list of excipients, see section “List of excipients”.
PHARMACEUTICAL FORM
Powder and suspension for suspension for injection in pre-filled
syringe
PENTAXIM is made up of a syringe pre-filled with a cloudy, whitish,
sterile suspension and a vial of