NIMENRIX POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

מדינה: סינגפור

שפה: אנגלית

מקור: HSA (Health Sciences Authority)

מרכיב פעיל:

Neisseria meningitidis group A polysaccharide; Neisseria meningitidis group C polysaccharide; Neisseria meningitidis group W-135 polysaccharide; Neisseria meningitidis group Y polysaccharide; Tetanus toxoid carrier protein

זמין מ:

PFIZER PRIVATE LIMITED

קוד ATC:

J07AH08

כמות:

5 micrograms

טופס פרצבטיות:

INJECTION, POWDER, FOR SOLUTION

הרכב:

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; Tetanus toxoid carrier protein ~44 micrograms

מסלול נתינה (של תרופות):

INTRAMUSCULAR

סוג מרשם:

Prescription Only

תוצרת:

Catalent Belgium S.A. (diluent in pre-filled syringe)

מצב אישור:

ACTIVE

תאריך אישור:

2014-04-03

עלון מידע

1 
NIMENRIX
MENINGOCOCCAL POLYSACCHARIDE SEROGROUPS A, C, W-135 AND
Y CONJUGATE 
VACCINE 
TM

QUALITATIVE AND QUANTITATIVE COMPOSITION 
After reconstitution, 1 dose (0.5 ml) contains 5
micrograms of polysaccharide for 
_Neisseria meningitidis_ serogroups A
1, 
C
1,
 W-135
1 
and Y
1
. 
1
conjugated to tetanus toxoid carrier protein 
44 micrograms 
PHARMACEUTICAL FORM 
Powder and solvent for solution for injection. 
CLINICAL PARTICULARS 
INDICATIONS 
Active immunization of individuals from 12
months of age against invasive 
meningococcal diseases caused by _Neisseria
meningitidis_ serogroups A, C, W-135

and Y (see section “_Pharmacodynamics_”). 
DOSAGE AND ADMINISTRATION 
PRIMARY VACCINATION 
A single 0.5 ml dose of the reconstituted vaccine is used
for immunization. 
BOOSTER VACCINATION 
_NIMENRIX™_ may be given in subjects who have previously been
vaccinated with a 
plain polysaccharide meningococcal vaccine. 
There are no data available in subjects previously vaccinated with
a meningococcal C 
conjugate vaccine. 
The need for a booster dose in subjects primed
with _NIMENRIX™_ has not been 
established. 

_NIMENRIX™_ should be used in accordance with
available official recommendations. 
_NIMENRIX™_ is for intramuscular injection only, preferably in
the deltoid muscle. 
In children 12 to 23 months of age, the vaccine may also
be administered in the 
anterolateral part of the thigh. (see sections “_Warnings and
Precautions_” and 
“_Interactions_”). 
The safety and efficacy of _NIMENRIX™_ in children under 12
months of age has not yet 
been established. No data are available. 
There are no data in individuals aged > 55 years. 
2 
CONTRAINDICATIONS 
_NIMENRIX™_ should not be administered to subjects with
hypersensitivity to the active 
substances or to any of the excipients contained in
the vaccine. (see secti

מאפייני מוצר

NIMENRIX™
MENINGOCOCCAL POLYSACCHARIDE GROUPS A, C, W-135 AND Y CONJUGATE
VACCINE
1.
NAME OF THE MEDICINAL PRODUCT
NIMENRIX™
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
After reconstitution, 1 dose (0.5 ml) contains 5 micrograms of
polysaccharide for
_Neisseria _
_meningitidis_
groups A*, C*, W-135* and Y*.
* conjugated to tetanus toxoid carrier protein 44 micrograms
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
4.
CLINICAL PARTICULARS
4.1.
INDICATIONS
NIMENRIX™
is indicated for active immunization of individuals from 6 weeks of
age against
invasive meningococcal diseases caused by
_Neisseria meningitidis_
groups A, C, W-135 and
Y.
4.2.
DOSAGE AND ADMINISTRATION
Posology
NIMENRIX™
should be used in accordance with available official recommendations.
TABLE 1: POSOLOGY
AGE GROUP
PRIMARY IMMUNIZATION
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 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).
_Previously vaccinated children from 12 months of age, adolescents and
adults_
NIMENRIX™
may be given as a booster dose to individuals who have previously
received
primary vaccination with a conjugated or plain polysaccharide
meningococcal vaccine (see
section 5.1).
Special populations
Individuals who have underlying conditions predisposing them to
meningococcal infection
due to anatomic or functional asplenia (such as sickle cell disease)
may receive at least one
dose of
NIM