MENQUADFI

País: Indonesia

Idioma: indonesio

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

Disponible desde:

KALVENTIS SINERGI FARMA - Indonesia -

Dosis:

10 MCG /10 MCG /10 MCG /10 MCG

formulario farmacéutico:

LARUTAN INJEKSI

Composición:

MENINGOCOCCAL POLYSACCHARIDE GROUP C CONJUGATED TO TETANUS TOXOID, MENINGOCOCCAL POLYSACCHARIDE GROUP Y CONJUGATED TO TETANUS TOXOID, MENINGOCOCCAL POLYSACCHARIDE GROUP W-135 CONJUGATED TO TETANUS TOXOID, MENINGOCOCCAL POLYSACCHARIDE GROUP A CONJUGATED TO

Unidades en paquete:

DUS, 1 VIAL @ 0.5 ML (1 DOSIS)

clase:

Obat

Fabricado por:

SANOFI PASTEUR, INC - United States of America

Estado de Autorización:

Berlakus/d 30-10-2028

Fecha de autorización:

2023-10-30

Ficha técnica

Page 1 of 14
MENQUADFI
TM
MENINGOCOCCAL GROUP A, C, W AND Y CONJUGATE VACCINE
SOLUTION FOR INJECTION
QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose (0.5 mL) contains:
_Neisseria meningitidis _group A polysaccharide
1
10 micrograms
_Neisseria meningitidis _group C polysaccharide
1
10 micrograms
_Neisseria meningitidis _group Y polysaccharide
1
10 micrograms
_Neisseria meningitidis _group W polysaccharide
1
10 micrograms
1
Conjugated to tetanus toxoid carrier protein
55 micrograms
For the full list of excipients, see section “_list of
excipients”_
PHARMACEUTICAL FORM
Solution for injection.
Clear colourless solution.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
MenQuadfi is indicated for active immunisation of individuals from the
age of 12 months and older against invasive
meningococcal disease caused by _Neisseria meningitidis _serogroups A,
C, Y and W-135 who travel to or reside in areas
with high endemic rates of of meningococcal disease or who are at high
risk of exposure to Neisseria meningitidis
serogroups A, C, Y, and W-135.
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Primary vaccination:
•
Individuals 12 months of age and older: One single dose (0.5 mL).
Booster vaccination: There are no data available to indicate the need
for or timing of a booster dose of
MenQuadfi (see section “Pharmacodynamic properties”).
_Other paediatric population _
The safety and immunogenicity of MenQuadfi in individuals under 12
months of age have not yet been established.
METHOD OF ADMINISTRATION
For intramuscular injection only, preferably in the deltoid region or
anterolateral thigh depending on the recipient's age and
muscle mass.
For instructions on handling of the vaccine before administration, see
section _“Special precautions for disposal and other _
DISETUJUI OLEH BPOM 20 OKTOBER 2023
ID REG: EREG10002212100147
Page 2 of 14
_handling”. _
CONTRAINDICATIONS
Hypersensitivity to the active substances or to any of the excipients
listed in section _“Pharmacodynamic properties”_ or after
previous admini