MENACTRA

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Diphtheria toxoid, Quantity: 48 microgram; Meningococcal polysaccharide Group Y, Quantity: 4 microgram; Meningococcal polysaccharide group W135, Quantity: 4 microgram; Meningococcal polysaccharide group C, Quantity: 4 microgram; Meningococcal polysaccharide group A, Quantity: 4 microgram

Available from:

Sanofi-Aventis Australia Pty Ltd

INN (International Name):

Diphtheria toxoid,Meningococcal polysaccharide group A,Meningococcal polysaccharide group C,Meningococcal polysaccharide group W

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: monobasic sodium phosphate; sodium chloride; dibasic sodium phosphate

Administration route:

Intramuscular

Units in package:

1 single dose vial per pack, 5 single dose vials per pack

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Menactra is indicated for active immunisation of individuals 9 months through 55 years of age for the prevention of invasive meningococcal disease caused by N meningitidis serogroups A, C, Y and W-135.,Menactra is not indicated for the prevention of meningitis caused by other microorganisms or for the prevention of invasive meningococcal disease caused by N meningitidis serogroup B.,Menactra is not indicated for treatment of meningococcal infections.,Menactra is not indicated for immunisation against diphtheria.

Product summary:

Visual Identification: A sterile, clear to slightly turbid solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Registered

Patient Information leaflet

MENACTRA
®
_Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria
Toxoid Conjugate Vaccine_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
READ ALL OF THIS LEAFLET CAREFULLY
BEFORE YOU ARE VACCINATED.
•
Keep this leaflet. You may need
to read it again.
•
If you have any further questions,
ask your doctor or pharmacist.
•
This vaccine has been prescribed
for you. Do not pass it on to
others.
•
If any of the side effects gets
serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or
pharmacist.
IN THIS LEAFLET:
•
What Menactra is and what it is
used for
•
Before you are given Menactra
How Menactra is given
•
Possible side effects
•
Storing Menactra Further
information
WHAT MENACTRA IS AND
WHAT IT IS USED FOR
Menactra is a vaccine.
Vaccines are used to protect you
against infectious diseases.
Menactra is given to protect persons
9 months through 55 years of age
against meningococcal disease
caused by four groups of Neisseria
meningitidis (A, C, Y and W-135).
The use of this vaccine should be in
accordance with official
recommendations. It allows the body
to produce enough antibodies to
provide a defence against the bacteria
that cause meningococcal disease.
However, as with all vaccines, 100%
protection cannot be guaranteed.
Menactra will not prevent meningitis
(an infection of the brain and spinal
cord coverings) caused by other
groups of Neisseria meningitidis or
meningitis caused by different kinds
of microbes.
BEFORE YOU ARE GIVEN
MENACTRA
_WHEN YOU MUST NOT BE GIVEN_
_IT_
•
Do not have Menactra if you are
allergic (hypersensitive) to the
active substance or any of the
other ingredients of Menactra
listed in the FURTHER
INFORMATION section
•
Children younger than 9 months
of age or adults older than 55
years of age
_TAKE SPECIAL CARE WITH_
_MENACTRA_
•
If you have an illness with febrile
or acute infection, the vaccination
shall be postponed until after you
have recovered
•
TELL YOUR DOCTOR IF YOU HAVE
BEEN PREVIOUSLY DIAGNOSED

Summary of Product characteristics

menactra-ccdsv14-piv3-13apr18-table-updated
Page 1 of 23
AUSTRALIAN PRODUCT INFORMATION – MENACTRA
®
(MENINGOCOCCAL (GROUPS A, C, Y AND W-135)
POLYSACCHARIDE DIPHTHERIA TOXOID CONJUGATE VACCINE)
1
NAME OF THE MEDICINE
MENACTRA
®
Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria
Toxoid Conjugate
Vaccine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 0.5 mL dose of vaccine contains:
Active ingredients:

Meningococcal polysaccharide* Group A
4.0 mcg/dose

Meningococcal polysaccharide* Group C
4.0 mcg/dose

Meningococcal polysaccharide* Group Y
4.0 mcg/dose

Meningococcal polysaccharide* Group W-135
4.0 mcg/dose

Diphtheria toxoid protein
Approximately 48 mcg/dose
* Each of the four polysaccharides is conjugated to diphtheria toxoid.
Menactra is a sterile, clear to slightly turbid solution of
_Neisseria meningitidis_
purified
capsular polysaccharides of groups A, C, Y and W-135, individually
conjugated to a carrier
protein. The protein is a purified
_Corynebacterium diphtheriae_
toxoid,
_formalin-detoxified_
.
Each 0.5 mL dose of vaccine is formulated in sodium phosphate buffered
isotonic sodium
chloride solution. No preservative or adjuvant is added.
There is no latex in any component of the vial.
3
PHARMACEUTICAL FORM
Solution for injection.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Menactra is indicated for active immunisation of individuals 9 months
through 55 years of
age for the prevention of invasive meningococcal disease caused by
_N_
_meningitidis_
serogroups A, C, Y and W-135.
menactra-ccdsv14-piv3-13apr18-table-updated
Page 2 of 23
Menactra is not indicated for the prevention of meningitis caused by
other microorganisms or
for the prevention of invasive meningococcal disease caused by
_N meningitidis_
serogroup B.
Menactra is not indicated for treatment of meningococcal infections.
Menactra is not indicated for immunisation against diphtheria.
4.2
DOSE AND METHOD OF ADMINISTRATION
Menactra should be administered as a 0.5 mL injection by the
INTRAMUSCULAR
route,