CERVARIX

Pays: Indonésie

Langue: indonésien

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

Ingrédients actifs:

HUMAN PAPILLOMAVIRUS TYPE 16 L1 PROTEIN, HUMAN PAPILLOMAVIRUS TYPE 18 L1 PROTEIN

Disponible depuis:

SMITHKLINE BEECHAM PHARMACEUTICALS - Indonesia

DCI (Dénomination commune internationale):

HUMAN PAPILLOMAVIRUS TYPE 16 L1 PROTEIN, HUMAN PAPILLOMAVIRUS TYPE 18 L1 PROTEIN

Dosage:

20 MCG /20 MCG

forme pharmaceutique:

SUSPENSI INJEKSI

Unités en paquet:

DUS, 1 PREFILLED SYRINGE @ 1 DOSIS (0,5 ML)

Fabriqué par:

GlaxoSmithKline Biologicals SA - Belgium

Date de l'autorisation:

2022-03-04

Résumé des caractéristiques du produit

ERS_leaCERinj_PI update GDS27 IPI21_circ2_28Jun22
Page 1 of 10
_ _
_ _
CERVARIX
HUMAN
PAPILLOMAVIRUS
VACCINE
TYPES
16
AND
18
(RECOMBINANT,
AS04
ADJUVANTED)
QUALITATIVE AND QUANTITATIVE COMPOSITION
Suspension for injection
1 dose (0.5 mL) contains:
Human Papillomavirus type 16 L1 protein
1
20 micrograms
Human Papillomavirus type 18 L1 protein
1
20 micrograms
3-_O_-desacyl-4’- monophosphoryl lipid A (MPL)
2
50 micrograms
Aluminium hydroxide, hydrated
2
0.5 milligrams Al
3+
1
L1 protein in the form of non-infectious virus-like particles (VLPs)
produced by recombinant DNA technology using a
Baculovirus expression system
2
The GlaxoSmithKline proprietary AS04 adjuvant system is composed of
aluminium hydroxide and 3-_O_-desacyl-4’-
monophosphoryl lipid A (MPL) (see _Pharmacodynamics_)
CLINICAL INFORMATIONS
INDICATIONS
_CERVARIX_ is indicated in females from 9 through 25 years of age for
the prevention of persistent infection,
premalignant cervical lesions and_ _cervical cancer (squamous cell
carcinoma and adenocarcinoma) caused by
oncogenic Human
Papillomavirus (HPV)
types 16,
and
18
(see
_Warnings and _
_Precautions and _
_Pharmacodynamics_ sections for more information on HPV 16, 18 and
other oncogenic types).
DOSAGE AND ADMINISTRATION
The vaccination schedule depends on the age of the subject.
AGE AT THE TIME OF THE FIRST INJECTION
IMMUNIZATION AND SCHEDULE
9 to and including 14 years*
Two doses each of 0.5 mL. The second dose given
between 5 and 13 months after the first dose
From 15 years and above
Three doses each of 0.5 mL at 0, 1, 6 months**
*If the second vaccine dose is administered before the 5
th
month after the first dose, a third dose should always be
administered.
**If flexibility in the vaccination schedule is necessary, the second
dose can be administered between 1 month and 2.5
months after the first dose and the third dose between 5 and 12 months
after the first dose.
_ _
Although the necessity for a booster dose has not been established, an
anamnestic response has been
observed after the adminis