NIMENRIX Meningococcal (Groups A, C, W-135, Y) Polysaccharide Tetanus Toxoid Conjugate Vaccine, injection vial and diluent syringe

Land: Australien

Språk: engelska

Källa: Department of Health (Therapeutic Goods Administration)

Aktiva substanser:

Meningococcal polysaccharide group C, Quantity: 5 microgram; Meningococcal polysaccharide Group Y, Quantity: 5 microgram; Meningococcal polysaccharide group W135, Quantity: 5 microgram; Meningococcal polysaccharide group A, Quantity: 5 microgram; Tetanus toxoid, Quantity: 44 microgram

Tillgänglig från:

Pfizer Australia Pty Ltd

INN (International namn):

Meningococcal polysaccharide group A,Meningococcal polysaccharide group C,Meningococcal polysaccharide group W135,Meningococcal

Läkemedelsform:

Injection, powder for

Sammansättning:

Excipient Ingredients: sucrose; trometamol hydrochloride

Administreringssätt:

Intramuscular

Enheter i paketet:

10, 1

Receptbelagda typ:

(S4) Prescription Only Medicine

Terapeutiska indikationer:

NIMENRIX is indicated for active immunisation of individuals from 6 weeks of age against invasive meningococcal diseases caused by Neisseria meningitidis groups A, C, W-135 and Y.

Produktsammanfattning:

Visual Identification: Nimenrix is presented as a powder in monodose vials.; Container Type: Multiple containers; 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

Bemyndigande status:

Licence status A

Tillstånd datum:

2013-08-29

Bipacksedel

NIMENRIX
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING NIMENRIX?
NIMENRIX is a vaccine used to help prevent meningococcal disease,
caused by four types of Neisseria meningitidis bacteria
(types A, C, W and Y). NIMENRIX works by causing your body to produce
its own protection (or antibodies), against these types of
meningococcal bacteria.
For more information, see Section 1. Why am I using NIMENRIX? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE NIMENRIX?
Do not use if you or your child have ever had an allergic reaction to
NIMENRIX or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you or your child have had a serious reaction
to any vaccine, have fainted with a previous vaccine, have had a
vaccine in the last 4 weeks, have any other medical conditions, take
any other medicines, or if you are pregnant or plan to become
pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use
NIMENRIX? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some vaccines or medicines may interfere with NIMENRIX and affect how
it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE NIMENRIX?
•
Your doctor or nurse will give NIMENRIX as an injection. The vaccine
is injected into muscle, usually in the thigh for babies from
6 to 12 weeks of age. In children from 12 months of age and adults,
NIMENRIX can be injected into the thigh or arm muscle.
More instructions can be found in Section 4. How do I use NIMENRIX? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING NIMENRIX?
THINGS YOU
SHOULD DO
•
Remind any doctor or dentist you visit that you are using NIMENRIX.
•
Keep a record of you or your child's vaccinations, and update this
after each injection.
•
Keep any follow-up visits with your doctor or clinic.
THINGS YOU
SHOU

Produktens egenskaper

Version: pfpnimev10921
Supersedes: pfpnimev10621
Page 1 of 35
AUSTRALIAN
PRODUCT
INFORMATION
–
NIMENRIX
®
(MENINGOCOCCAL
POLYSACCHARIDE
GROUPS A, C, W-135 AND Y CONJUGATE VACCINE)
1
NAME OF THE MEDICINE
Meningococcal polysaccharide groups A, C, W-135 and Y conjugate
vaccine.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
NIMENRIX powder and solvent for solution for injection in pre-filled
syringe.
After reconstitution, 1 dose (0.5 mL) contains:
Meningococcal polysaccharide - Group A*
5 micrograms
Meningococcal polysaccharide - Group C*
5 micrograms
Meningococcal polysaccharide - Group W-135*
5 micrograms
Meningococcal polysaccharide - Group Y*
5 micrograms
*conjugated to tetanus toxoid carrier protein
44 micrograms
For the full list of excipients, see Section 6.1 List of excipients.
No preservative or adjuvant is added.
3
PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
The powder or cake is white.
The solvent is clear and colourless.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
NIMENRIX is indicated for active immunisation of individuals from 6
weeks of age against
invasive meningococcal diseases caused by
_Neisseria meningitidis_
groups A, C, W-135 and
Y.
4.2 DOSE AND METHOD OF ADMINISTRATION
NIMENRIX should be used in accordance with available official
recommendations.
Version: pfpnimev10921
Supersedes: pfpnimev10621
Page 2 of 35
DOSAGE
AGE GROUP
PRIMARY IMMUNISATION
BOOSTER
Infants from 6 weeks to less
than 6 months of age*
1,2
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 Pharmacodynamic properties for further information.
**In some situations, consideration may be given to admini