Nimenrix Powder and Solvent for Solution for Injection

Země: Malajsie

Jazyk: angličtina

Zdroj: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktivní složka:

meningococcus A, purified polysaccharides antigen; meningococcus W135, purified polysaccharides antigen; meningococcus y, purified polysaccharides antigen; meningococcus C, purified polysaccharides antigen conjugated

Dostupné s:

PFIZER (MALAYSIA) SDN. BHD.

INN (Mezinárodní Name):

meningococcus A, purified polysaccharides antigen; meningococcus W135, purified polysaccharides antigen; meningococcus y, purified polysaccharides antigen; meningococcus C, purified polysaccharides antigen conjugated

Jednotky v balení:

2 ml; 2 ml; 2 ml; 1.25ml mL

Výrobce:

PFIZER MANUFACTURING BELGIUM NV,

Informace pro uživatele

Not Applicable

Charakteristika produktu

Pfizer Confidential
1
NIMENRIX
TM
MENINGOCOCCAL POLYSACCHARIDE GROUPS A, C, W-135 AND Y CONJUGATE
VACCINE
1. NAME OF THE MEDICINAL PRODUCT
Nimenrix powder and solvent for solution for injection in pre-filled
syringe
Meningococcal group A, C, W-135, and Y conjugate vaccine
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
After reconstitution, 1 dose (0.5 ml) contains
_Neisseria meningitidis_ group A polysaccharide*
5 micrograms
_Neisseria meningitidis _group C polysaccharide*
5 micrograms
_Neisseria meningitidis_ group W-135 polysaccharide*
5 micrograms
_Neisseria meningitidis_ group Y polysaccharide*
5 micrograms
*conjugated to tetanus toxoid carrier protein
44 micrograms
The powder or cake is white. The solvent is clear and colourless.
3. PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
4. CLINICAL INFORMATION
4.1 THERAPEUTIC INDICATIONS
Active
immunisation
of
individuals
from
6
weeks
of
age
against
invasive
meningococcal disease caused by _Neisseria meningitidis_ groups A, C,
W-135, and Y
(see section 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Nimenrix should be used in accordance with available official
recommendations.
TABLE 1: POSOLOGY
AGE GROUP
PRIMARY IMMUNISATION
BOOSTER
Infants from 6 weeks to less than 6
months of age
*
Two doses, each of 0.5 ml,
with the first dose given from
6 weeks of age, with an
interval of 2 months between
doses
At 12 months of age
Unvaccinated infants from 6 months to
less than 12 months of age**
One dose of 0.5 ml given from
6 months of age
At 12 months of age with a
minimum interval of at least
2 months after the primary
Pfizer Confidential
2
dose
Children from 12 months of age,
adolescents and adults
**
One dose of 0.5 ml
Not routinely administered
* See section 5.1 for further information.
**In some situations, consideration may be given to administering an
additional primary dose or a booster dose of
Nimenrix (see sections 4.4 and 5.1 for further information).
Long-term antibody persistence data following vaccination with
Nimenrix are
available up