MENQUADFI SOLUTION FOR INJECTION

Ülke: Singapur

Dil: İngilizce

Kaynak: HSA (Health Sciences Authority)

Aktif bileşen:

Meningococcal Polysaccharide, Serogroup A (Monovalent Conjugate); Meningococcal Polysaccharide, Serogroup C (Monovalent Conjugate); Meningococcal Polysaccharide, Serogroup W-135 (Monovalent Conjugate); Meningococcal Polysaccharide, Serogroup Y (Monovalent Conjugate); Tetanus Toxoid, Filtered Concentrate (Carrier Protein)

Mevcut itibaren:

SANOFI-AVENTIS SINGAPORE PTE. LTD.

ATC kodu:

J07AH08

Farmasötik formu:

INJECTION, SOLUTION

Kompozisyon:

Meningococcal Polysaccharide, Serogroup A (Monovalent Conjugate) 10 mcg/ 0.5 mL; Meningococcal Polysaccharide, Serogroup C (Monovalent Conjugate) 10 mcg/ 0.5 mL; Meningococcal Polysaccharide, Serogroup W-135 (Monovalent Conjugate) 10 mcg / 0.5mL; Meningococcal Polysaccharide, Serogroup Y (Monovalent Conjugate) 10 mcg/ 0.5 mL; Tetanus Toxoid, Filtered Concentrate (Carrier Protein) 55 mcg/ 0.5 mL

Uygulama yolu:

INTRAMUSCULAR

Reçete türü:

Prescription Only

Tarafından üretildi:

Sanofi Pasteur, Inc.

Yetkilendirme durumu:

ACTIVE

Yetkilendirme tarihi:

2022-03-29

Ürün özellikleri

1
SG/MenQ/0323/EU SmPC0223
NAME OF THE MEDICINAL PRODUCT
MenQuadfi solution for injection
Meningococcal Group A, C, W and Y conjugate vaccine
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, W, and Y.
The use of this vaccine should be in accordance with available
official recommendations.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Primary vaccination:
•
Individuals 12 months of age and older: One single dose (0.5 mL).
Booster vaccination:
•
A single 0.5 mL dose of MenQuadfi may be used to boost subjects who
have previously received a
meningococcal vaccine containing the same serogroups (see section
Pharmacodynamic properties).
•
Long-term antibody persistence data following vaccination with
MenQuadfi are available up to 7
years after vaccination (see sections Special warnings and precautions
for use and Pharmacodynamic
properties).
•
There are no data available to indicate the need for or timing of a
booster dose of MenQuadfi (see
section Pharmacodynamic properties).
_ _
_ _
_ _
2
SG/MenQ/0323/EU SmPC0223
_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 m