VARIVAX

Negara: Indonesia

Bahasa: Bahasa Indonesia

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

Bahan aktif:

LIVE ATTENUATED VARICELLA ZOSTER VIRUS (OKA STRAIN)

Tersedia dari:

ORGANON PHARMA INDONESIA TBK - Indonesia

INN (Nama Internasional):

LIVE ATTENUATED VARICELLA ZOSTER VIRUS (OKA STRAIN)

Dosis:

13500 PFU

Bentuk farmasi:

SERBUK INJEKSI

Unit dalam paket:

DUS, 1 VIAL @ 1 DOSE + 1 PRE-FILLED SYRINGE PELARUT @ 0,7 ML

Diproduksi oleh:

MERCK SHARP & DOHME CORP. - United States of America

Tanggal Otorisasi:

2021-09-11

Karakteristik produk

VARIVAX (Refrigerated)
[Varicella Virus Vaccine Live (Oka/Merck), Refrigerator-Stable
Formulation]
I.
THERAPEUTIC CLASS
VARIVAX (Refrigerated) is a live, attenuated virus vaccine (a
lyophilized preparation of
the Oka/Merck strain of varicella).
II.
INDICATIONS
VARIVAX (Refrigerated) is indicated for vaccination against varicella
in individuals 12
months of age and older.
III.
DOSAGE AND ADMINISTRATION
FOR SUBCUTANEOUS ADMINISTRATION. Do not inject intravenously.
Children 12 months to 12 years of age should receive a single 0.5 mL
dose administered
subcutaneously.
Adolescents and adults 13 years of age and older should receive a 0.5
mL dose
administered subcutaneously at elected date and a second 0.5 mL dose 4
to 8 weeks
later.
The outer aspect of the upper arm (deltoid region) is the preferred
site of injection.
Methods of administration
Prefilled syringe of diluent
To reconstitute the vaccine, inject all of the diluent (0.7 mL) in the
prefilled syringe into
the vial of lyophilized vaccine and gently agitate to mix thoroughly.
Withdraw the entire
DISETUJUI OLEH BPOM : 18/01/2021
ID : EREG100373VR12000329
contents into the syringe and inject the total volume (about 0.5 mL)
of reconstituted
vaccine subcutaneously, preferably into the outer aspect of the upper
arm (deltoid
region) or the anterolateral thigh. IT IS RECOMMENDED THAT THE VACCINE
BE
ADMINISTERED IMMEDIATELY AFTER RECONSTITUTION, TO MINIMIZE LOSS OF
POTENCY. DISCARD IF RECONSTITUTED VACCINE IS NOT USED WITHIN 30
MINUTES.
Do not freeze reconstituted vaccine.
Parenteral drug products should be inspected visually for particulate
matter and
discoloration prior to administration, whenever solution and container
permit. VARIVAX
(Refrigerated) when reconstituted is a clear, colorless to pale yellow
liquid.
CAUTION: A sterile syringe free of preservatives, antiseptics, and
detergents should be
used for each injection and/or reconstitution of VARIVAX
(Refrigerated) because these
substances may inactivate the vaccine virus.
It is important to use a separate steril