Menactra® solution for injection

Land: Singapur

Sprache: Englisch

Quelle: HSA (Health Sciences Authority)

Wirkstoff:

Diphtheria Toxoid Protein; Meningococcal (Serogroup A) Polysaccharide (Monovalent Conjugate); Meningococcal (Serogroup C) Polysaccharide (Monovalent Conjugate); Meningococcal (Serogroup W-135) Polysaccharide (Monovalent Conjugate); Meningococcal (Serogroup Y) Polysaccharide (Monovalent Conjugate)

Verfügbar ab:

SANOFI-AVENTIS SINGAPORE PTE. LTD.

ATC-Code:

J07AH08

Dosierung:

48 microgram (Diptheria toxoid quantity is approximate and dependent on the conjugate polysaccharide to protein ratio)

Darreichungsform:

INJECTION, SOLUTION

Zusammensetzung:

Diphtheria Toxoid Protein 48 mcg/dose (0.5 ml) (Diphtheria toxoid quantity is approximate and dependent on the conjugate polysaccharide to protein ratio); Meningococcal (Serogroup A) Polysaccharide (Monovalent Conjugate) 4 mcg/dose (0.5 ml); Meningococcal (Serogroup C) Polysaccharide (Monovalent Conjugate) 4 mcg/dose (0.5 ml); Meningococcal (Serogroup W-135) Polysaccharide (Monovalent Conjugate) 4 mcg/dose (0.5 ml); Meningococcal (Serogroup Y) Polysaccharide (Monovalent Conjugate) 4 mcg/dose (0.5 ml)

Verabreichungsweg:

INTRAMUSCULAR

Verschreibungstyp:

Prescription Only

Hergestellt von:

Sanofi Pasteur Inc.

Berechtigungsstatus:

ACTIVE

Berechtigungsdatum:

2011-02-24

Gebrauchsinformation

Menactra Singapore 
LE6494-6495, 24May13-v0.3 
MENINGOCOCCAL (GROUPS A, C,
Y AND W-135) POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE 
VACCINE 

MENACTRA
® 
FOR INTRAMUSCULAR INJECTION 

INDICATIONS AND USAGE 

Menactra
®
, Meningococcal (Groups A, C, Y and
W-135) Polysaccharide Diphtheria Toxoid 
Conjugate
Vaccine, is indicated for active immunization to  prevent invasive
meningococcal 
disease caused by _Neisseria meningitidis _serogroups A, C,
Y and W-135. Menactra is approved 
for use in individuals 9 months through 55 years of age. 

Menactra vaccine is not indicated for the prevention
of meningitis caused by other 
microorganisms or for the prevention
of invasive meningococcal disease caused by _Neisseria _
_meningitidis _serogroup B. 

DOSAGE AND ADMINISTRATION 

Menactra
vaccine should be administered as a  single 0.5 mL injection by the INTRAMUSCULAR 
route, preferably in the anterolateral thigh or deltoid region
depending on the recipient's age and 
muscle mass. 

In children 9 through 23 months of age, Menactra is given
as a 2-dose series at least three 
months apart. 

Individuals 2 through 55 years of age receive a single dose. 

Do not administer this product intravenously, subcutaneously,
or intradermally. 

The need for, or timing of,
a booster dose of Menactra vaccine has not yet been
determined. 

Parenteral drug products should
be inspected visually for container integrity,
particulate matter, 
and discoloration prior to administration, whenever solution and
container permit. 

CONTRAINDICATIONS 

HYPERSENSITIVITY 

Severe allergic reaction (e.g., anaphylaxis) after a
previous  dose of a meningococcal capsular 
polysaccharide-, diphtheria toxoid-  or CRM
197
-containing vaccine, or to any component of 
Menactra vaccine (see DESCRIPTION). 

. 

1 

Menactra Singapore 
LE6494-6495,�

Fachinformation

1
MENINGOCOCCAL (GROUPS A, C, Y AND W-135) POLYSACCHARIDE DIPHTHERIA
TOXOID CONJUGATE
VACCINE
MENACTRA
®
FOR INTRAMUSCULAR INJECTION
INDICATIONS AND USAGE
Menactra
®
, Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria
Toxoid
Conjugate Vaccine, is indicated for active immunization to prevent
invasive meningococcal
disease caused by
_Neisseria meningitidis _
serogroups A, C, Y and W-135. Menactra is approved
for
use in individuals 9 months through 55 years of age. Menactra does not
prevent
_N _
_meningitidis_
serogroup B disease.
DOSAGE AND ADMINISTRATION
PREPARATION FOR ADMINISTRATION
Menactra is a clear to slightly turbid solution. Parenteral drug
products should be inspected
visually for particulate matter and discoloration prior to
administration, whenever solution and
container permit. If any of these conditions exist, the vaccine should
not be administered.
Withdraw the 0.5 mL dose of vaccine from the single-dose vial using a
sterile needle and
syringe.
DOSE AND SCHEDULE
Menactra is administered as a single 0.5 mL dose by
INTRAMUSCULAR
injection, preferably in the
anterolateral thigh or deltoid region depending on the recipient's age
and muscle mass.
Do not administer this product intravenously or subcutaneously.
PRIMARY VACCINATION:

In children 9 through 23 months of age, Menactra is given as a 2-dose
series at least three
months apart.

Individuals 2 through 55 years of age, Menactra is given as a single
dose.
BOOSTER VACCINATION:

A single booster dose may be given to individuals 15 through 55 years
of age at
continued risk for meningococcal disease, if at least 4 years have
elapsed since the prior
dose.
DOSAGE FORMS AND STRENGTHS
2
Menactra is a solution supplied in 0.5 mL single-dose vials. [See
DESCRIPTION
for a
complete listing of ingredients.]
CONTRAINDICATIONS
HYPERSENSITIVITY
Severe allergic reaction (e.g., anaphylaxis) after a previous dose of
a meningococcal capsular
polysaccharide-, diphtheria toxoid- or CRM
197
-containing vaccine, or to any component of
Menactra [se