MenQuadfi meningococcal (Groups A,C,Y,W) polysaccharide tetanus toxoid conjugate vaccine, solution for injection, vial

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

Meningococcal polysaccharide group W135, Quantity: 10 microgram; Meningococcal polysaccharide group C, Quantity: 10 microgram; Meningococcal polysaccharide group A, Quantity: 10 microgram; Meningococcal polysaccharide Group Y, Quantity: 10 microgram

Tilgjengelig fra:

Sanofi-Aventis Australia Pty Ltd

Legemiddelform:

Injection, solution

Sammensetning:

Excipient Ingredients: sodium acetate; Tetanus toxoid; sodium chloride; water for injections

Administreringsrute:

Intramuscular

Enheter i pakken:

10 vials per pack, 1 vial per pack

Resept typen:

(S4) Prescription Only Medicine

Indikasjoner:

MenQuadfi is indicated for active immunisation for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W and Y.,The use of MenQuadfi should be in accordance with official recommendations.

Produkt oppsummering:

Visual Identification: Clear, sterile, preservative-free solution; Container Type: Vial; 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

Autorisasjon status:

Registered

Autorisasjon dato:

2020-10-29

Informasjon til brukeren

MENQUADFI
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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, nurse or
pharmacist.
▼
This medicine is new or being used differently. Please report side
effects. See the full CMI for further details
1.
WHY AM I USING MENQUADFI?
MenQuadfi is a vaccine. It is used to help protect you or your child
against infections caused by a bacteria (germs) called “Neisseria
meningitides” types A, C, W and Y. MenQuadfi can be given to
children (12 months of age and above), adolescents, adults and the
elderly.
For more information, see Section 1. Why am I using MenQuadfi? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE MENQUADFI?
Do not use if you have ever had an allergic reaction to MenQuadfi or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR, NURSE OR PHARMACIST IF YOU HAVE ANY OTHER MEDICAL
CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE
PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
MenQuadfi? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with MenQuadfi and may affect how it
works. Tell your doctor nurse or pharmacist if you are taking,
have recently taken or might take any other vaccines or medicines,
including medicines obtained without a prescription.
For more information, see Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE MENQUADFI?
MenQuadfi is given by your doctor, nurse or pharmacist.
More instructions can be found in Section 4. How do I use MenQuadfi?
in the full CMI.
5.
WHAT SHOULD I KNOW AFTER USING MENQUADFI?
THINGS YOU
SHOULD DO
•
CALL YOUR DOCTOR, NURSE OR PHARMACIST STRAIGHT AWAY IF YOU:
•
NOTICE SIGNS OF ALLERGIC REACTION WHICH INCLUDE RASH, ITCHING,
DIFFICULTY BREATHING, SHORTNESS OF
BREATH OR SWELLING OF THE FACE, LIPS, THROAT OR TONGUE.
DRIVING OR USING MACHINES
•
MENQUADFI IS NOT LIKELY T

Preparatomtale

Property of the Sanofi group - strictly confidential
menq-cccdsv4-piv3-19jan23
Page 1 of 28
This medicinal product is subject to additional monitoring in
Australia. This will allow quick
identification of new safety information. Healthcare professionals are
asked to report any
suspected adverse events at www.tga.gov.au/reporting-problems.
AUSTRALIAN PRODUCT INFORMATION – MENQUADFI
®
(MENINGOCOCCAL (GROUPS A, C, Y, W) POLYSACCHARIDE
TETANUS TOXOID CONJUGATE VACCINE) SOLUTION FOR
INJECTION
1
NAME OF THE MEDICINE
Meningococcal (Groups A, C, Y, W) Polysaccharide Tetanus Toxoid
Conjugate Vaccine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 0.5 mL dose of vaccine contains:
•
Meningococcal polysaccharide* Group A
10.0 microgram/dose
•
Meningococcal polysaccharide* Group C
10.0 microgram/dose
•
Meningococcal polysaccharide* Group Y
10.0 microgram/dose
•
Meningococcal polysaccharide* Group W-135
10.0 microgram/dose
* Each of the four polysaccharides is conjugated to tetanus toxoid
(approximately 55 microgram/dose)
MenQuadfi is a sterile solution of
_Neisseria meningitidis _
(
_N. meningitidis_
) purified capsular
polysaccharides of groups A, C, W-135, and Y, individually conjugated
to tetanus toxoid protein
prepared from cultures of
_Clostridium tetani_
. No preservative or adjuvant is added during
manufacture.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Solution for injection.
MenQuadfi is a clear, colourless, sterile, preservative-free solution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
MenQuadfi is indicated for active immunisation for the prevention of
invasive meningococcal
disease caused by
_Neisseria meningitidis_
serogroups A, C, W and Y.
▼

Property of the Sanofi group - strictly confidential
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Page 2 of 28
The use of MenQuadfi should be in accordance with official
recommendations.
4.2
DOSE AND METHOD OF ADMINISTRATION
MenQuadfi should be administered as a 0.5 mL single dose injection by
the intramuscular route
only