TRUMENBA (Meningococcal group B vaccine) suspension for injection pre-filled syringe

Country: Ավստրալիա

language: անգլերեն

source: Department of Health (Therapeutic Goods Administration)

active_ingredient:

Neisseria meningitidis serogroup B recombinant lipidated- factor H binding protein subfamily A, Quantity: 60 microgram; Neisseria meningitidis serogroup B recombinant lipidated- factor H binding protein subfamily B, Quantity: 60 microgram

MAH:

Pfizer Australia Pty Ltd

INN:

Neisseria meningitidis serogroup B recombinant lipidated- factor H binding protein subfamily A,Neisseria meningitidis serogroup

pharmaceutical_form:

Injection, suspension

composition:

Excipient Ingredients: water for injections; aluminium phosphate; histidine; sodium chloride; polysorbate 80

administration_route:

Intramuscular

units_in_package:

1

prescription_type:

(S4) Prescription Only Medicine

therapeutic_indication:

Trumenba is indicated in individuals 10 years and older for active immunisation to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B.

leaflet_short:

Visual Identification: Homogenous white suspension; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 48 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

authorization_status:

Licence status A

authorization_date:

2017-09-14

PIL

TRUMENBA
®
_Meningococcal group B vaccine_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Trumenba.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you or your child being
given Trumenba against the benefits
it is expected to have for you or your
child.
IF YOU HAVE ANY CONCERNS ABOUT THIS
VACCINATION, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT TRUMENBA IS
USED FOR
Trumenba is a vaccine, a type of
medicine used to protect against
infectious diseases.
Trumenba is used to prevent invasive
meningococcal disease caused by
bacteria called Neisseria meningitidis
serogroup B.
The Neisseria meningitidis bacteria
can cause serious and sometimes life-
threatening infections such as
meningitis (inflammation of the
covering of the brain and spinal cord)
and sepsis (blood poisoning).
Trumenba does not help to protect
against meningococcal disease
caused by other types of Neisseria
bacteria.
It does not protect against meningitis
and blood poisoning caused by other
bacteria or viruses.
When a person is given Trumenba,
the immune system (the body's
natural defence system) will produce
its own protection (antibodies)
against disease.
Your body usually takes several
weeks after vaccination to develop
protection against invasive
meningococcal disease.
Most people will produce enough
antibodies to protect them against
invasive meningococcal disease.
However, as with all vaccines, 100%
protection cannot be guaranteed.
Trumenba will not give you or your
child meningococcal disease.
The chance of a severe reaction from
Trumenba is very small, but the risks
from not being vaccinated against
invasive meningococcal disease may
be very serious.
Trumenba is used in adults and
children aged 10 years and older.
BEFORE YOU ARE GIVEN
TRUMENBA
_WHEN YOU MUST NOT BE GIVEN_
_IT_
YOU SHOULD NOT BE GIVEN TR

SPC

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AUSTRALIAN
PRODUCT
INFORMATION
-
TRUMENBA
 (MENINGOCOCCAL GROUP B VACCINE)
SUSPENSION FOR INJECTION PRE-FILLED SYRINGE
1.
NAME OF THE MEDICINE
Meningococcal group B vaccine.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 0.5 mL dose contains:
_Neisseria meningitidis_
serogroup B recombinant lipidated-
factor H binding protein subfamily A 60 µg
factor H binding protein subfamily B 60 µg
Trumenba is a sterile homogeneous white suspension composed of two
recombinant
lipidated factor H binding protein (fHBP) variants from
_Neisseria meningitidis_
serogroup B,
one from fHBP subfamily A and one from subfamily B (A05 and B01,
respectively).
EXCIPIENT(S) WITH KNOWN EFFECT:
•
Sodium
For the full list of excipients, see Section 6.1 - List of excipients.
3.
PHARMACEUTICAL FORM
Suspension for injection pre-filled syringe.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Trumenba is indicated in individuals 10 years and older for active
immunisation to prevent
invasive meningococcal disease caused by
_Neisseria meningitidis_
serogroup B.
4.2
DOSE AND METHOD OF ADMINISTRATION
The vaccine should be shaken vigorously to ensure that a homogeneous
white suspension is
obtained. Do not use the vaccine if it cannot be re-suspended.
The vaccine should be visually inspected for particulate matter and
discoloration prior to
administration. This product should not be used if particulate matter
or discoloration is found.
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DOSAGE
Standard schedule for routine immunisation: 2 doses (0.5 ml each)
administered at 0 and 6
months.
Schedule for individuals at increased risk of invasive meningococcal
disease: 2 doses (0.5
ml each) administered at least 1 month apart, followed by a third dose
at least 4 months after
the second dose.
The choice of dosing schedule may depend on the risk of exposure and
the patient’s
susceptibility to meningococcal B disease.
METHOD OF ADMINISTRATION
For intramuscular injection only