VARIVAX

Pays: Indonésie

Langue: indonésien

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

Ingrédients actifs:

LIVE ATTENUATED VARICELLA ZOSTER VIRUS (OKA STRAIN)

Disponible depuis:

ORGANON PHARMA INDONESIA TBK - Indonesia

DCI (Dénomination commune internationale):

LIVE ATTENUATED VARICELLA ZOSTER VIRUS (OKA STRAIN)

Dosage:

13500 PFU

forme pharmaceutique:

SERBUK INJEKSI

Unités en paquet:

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

Fabriqué par:

MERCK SHARP & DOHME CORP. - United States of America

Date de l'autorisation:

2021-09-11

Résumé des caractéristiques du produit

_ _
VARIVAX (REFRIGERATED)
[VARICELLA VIRUS VACCINE LIVE (OKA/MERCK), REFRIGERATOR-STABLE
FORMULATION]
(POWDER FOR INJECTION)
I.
THERAPEUTIC CLASS
VARIVAX (Refrigerated) is a live, attenuated virus vaccine (a
lyophilized preparation of
the Oka/Merck strain of varicella). Each 0.5 mL dose contains a
minimum of 1350 PFU
(plaque-forming units) of Oka/Merck varicella virus.
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 0.5 mL dose
administered
subcutaneously. If a second dose is administered, there should be a
minimum interval
of 3 months between doses (see
CLINICAL PHARMACOLOGY).
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.
DISETUJUI OLEH BPOM: 27 SEPTEMBER 2023
ID EREG100373VR12300285
_ _
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
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. Before
reconstitution, the lyophilized vaccine is a white compact crystalline
plug. VARIVAX
(