HEALIVE®

Negara: Indonesia

Bahasa: Bahasa Indonesia

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

Bahan aktif:

INACTIVATED HEPATITIS A VIRUS

Tersedia dari:

ETANA BIOTECHNOLOGIES INDONESIA - Indonesia

INN (Nama Internasional):

INACTIVATED HEPATITIS A VIRUS

Dosis:

250 U

Bentuk farmasi:

INJEKSI

Unit dalam paket:

DUS, 1 VIAL @ 0.5 ML

Diproduksi oleh:

SINOVAC BIOTECH CO., LTD. - China

Tanggal Otorisasi:

2022-02-17

Karakteristik produk

Respiratory system disorders:
Upper respiratory tract infec�on
Skin and appendages disorders:
Pruritus, Ur�caria, Ur�caria Acute, Erythema induratum, Anigoedema
Vascular (extracardiac) disorders:
Purpura allergic
OVERDOSE
Few cases of overdose have been reported with Healive
®
during the post-marke�ng surveillance. Adverse reac�ons reported
following overdose were similar
to those reported with normal vaccina�on.
PHARMACODYNAMIC PROPER�ES
Pharmacotherapeu�c group: Viral vaccine, ATC code: J07BC02.
Healive
®
confers immunity against hepa��s A virus: by inducing an�body
�tres greater than those obtained a�er passive immuniza�on with
immunoglobulin.
The efficacy of Healive
®
was evaluated in different community outbreaks. These studies
indicated that administra�on of a single dose of Healive
®
contributed
to termina�on of the outbreaks. In one study, the peak of HAV
outbreak began to decrease in 2 weeks a�er the primary injection. In
another study, the
protec�ve efficacy was 100% in students who received vaccina�on.
In order to ensure lon
g term protec�on, a booster dose should be given between 6 and 12
months a�er the primary dose. In clinical trials, virtually all
vaccinees were seroposi�ve one month a�er the booster dose.
The long-term persistence of protec�ve an�body levels to
hepati�s A virus a�er a second dose (booster) of Healive
®
has not been fully evaluated.
Nevertheless, serological data show con�nuing protec�on against
hepa��s A for up to
5 years in subjects who administrated a�er the full immuniza�on.
PHARMACOKINE�C PROPER�ES
Not applicable to vaccine for prophylaxis.
PRECLINICAL SAFETY DATA
Long-term toxicity study has been conducted for Healive
®
on mice and rats. No toxicity was observed in men�oned studies.
IMMUNOGENICITY DATA
The seroconversion rate and geometric mean concentra�on (GMC) of
an�body were used to evaluate the immunogenicity of Healive
®
. Seroconversion was
defined by a concentra�on of less than 20