IMOVAX POLIO

Negara: Indonesia

Bahasa: Bahasa Indonesia

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

Bahan aktif:

POLIOMYELITIS VACCINE INACTIVATED

Tersedia dari:

AVENTIS PHARMA - Indonesia

INN (Nama Internasional):

POLIOMYELITIS VACCINE INACTIVATED

Dosis:

0,5 ML

Bentuk farmasi:

CAIRAN INJEKSI

Unit dalam paket:

DUS, 10 VIAL @ 5 ML (10 DOSIS)

Diproduksi oleh:

SANOFI PASTEUR - France

Tanggal Otorisasi:

2018-05-09

Karakteristik produk

IMOVAX POLIO
POLIOMYELITIS VACCINE INACTIVATED
COMPOSITION
Each 0.5 mL immunizing dose contains:
-
Inactivated poliovirus vaccine type 1 … 40 Antigen D units
-
Inactivated poliovirus vaccine type 2 … 8 Antigen D units
-
Inactivated poliovirus vaccine type 3 … 32 Antigen D units
-
2 phenoxyethanol ……………………… 2-3 µl
-
Formaldehyde …………………………. 2-20 µg
PHARMACEUTICAL FORM
Suspension for injection in prefilled syringe vial.
IMOVAX POLIO is a clear and colorless suspension.
THERAPEUTIC INDICATIONS
The prevention of poliomyelitis in immunocompromised infants, and
immunocompromised children, their
household contacts, individuals in whom oral polio vaccine is
contraindicated.
CONTRAINDICATIONS
-
Usual contraindications to any immunization: vaccination should be
postponed in those suffering from
fever, acute disease or progressive chronic disease.
-
Hypersensitivity subsequent to a previous injection of the vaccine.
-
Acute febrile infectious disease: wait till the recovery.
-
True allergy to streptomycin, neomycin, or polymixin B.
SPECIAL WARNING AND PRECAUTIONS FOR USE
Do
not
inject
by
the
intravascular
route.
Ensure
that
the
needle
does
not
enter
a
blood
vessel.
Immunosuppressive treatment or an immunodeficiency condition may
induce a reduced immune response
to the vaccine. It is then recommended to wait until the end of the
treatment before vaccinating or to make
sure that the subject is well protected. Nevertheless, vaccination of
subjects with chronic immunodeficiency
such as HIV infection is recommended even if the immune response may
be limited.
Given that each dose may contain traces of neomycin, streptomycin and
polymyxin B, this vaccine should
be used with caution in those individuals presenting with a
hypersensitivity to these antibiotics.
As with all injectable vaccines, IMOVAX POLIO must be administered
with caution to subjects with
thrombocytopenia or a bleeding disorder since bleeding may occur
following an intramuscular
administration to these subjects.
As with