MENVEO

Страна: Індонезія

мова: індонезійська

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

Одиниць в упаковці:

DUS, 1 DOSIS @ (1 VIAL SERBUK INJEKSI + 1 VIAL LARUTAN INJEKSI @ ...

Дата Авторизація:

2022-07-12

Характеристики продукта

ERS_leaMENinj_MA Transfer SBP to GWI (Projecr Rinjani)_circ1_22Nov21
_Page 1 of 11_
MENVEO
Powder and solution for injection
Meningococcal Group A, C, W135 and Y conjugate vaccine
QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose (0.5 mL of the reconstituted vaccine) contains:
Each powder vial contains:
• Meningococcal group A oligosaccharide_ _
10 micrograms
Conjugated to _Corynebacterium diphtheriae_ CRM
197
protein
16.7 to 33.3 micrograms
Each solution vial contains:
• Meningococcal group C oligosaccharide_ _
5 micrograms
Conjugated to _Corynebacterium diphtheriae_ CRM
197
protein
7.1 to 12.5 micrograms
• Meningococcal group W135 oligosaccharide_ _
_ _
_ _
_ _
5 micrograms
Conjugated to _Corynebacterium diphtheriae_ CRM
197
protein
3.3 to 8.3 micrograms
• Meningococcal group Y oligosaccharide_ _
_ _
_ _
_ _
_ _
5 micrograms
Conjugated to _Corynebacterium diphtheriae _CRM
197
protein
5.6 to 10.0 micrograms
For a full list of excipients, see section “_List of Excipients_”.
PHARMACEUTICAL FORM
Powder and solution for solution for injection (powder and solution
for injection).
The powder is a white to off-white cake.
The solution is a colourless clear solution.
CLINICAL PARTICULARS
INDICATIONS
_MENVEO_ is indicated for active immunization of travellers to endemic
area in children (from 7 months of
age), adolescent and adults at risk of exposure to _Neisseria
meningitidis_ serogroup A, C, W135, and Y
to prevent invasive disease.
The use of this vaccine should be in accordance with official
recommendations.
DOSAGE AND ADMINISTRATION
DOSING IN DIFFERENT POPULATIONS:
Vaccine schedule for children from 7 to 23 months of age
In unvaccinated children from 7 to 23 months of age, _MENVEO_ should
be administered as two doses,
each as a single dose (0.5 mL), with the second dose administered in
the second year of life and at
least two months after the first dose.
Vaccine schedule for children 2 to 10 years of age
_MENVEO _is to be administered intramuscularly as a single dose (0.5
mL) injection. For children 2 th