MenQuadfi

Ország: Új-Zéland

Nyelv: angol

Forrás: Medsafe (Medicines Safety Authority)

Vedd Meg Most

Letöltés Betegtájékoztató (PIL)
13-02-2023
Letöltés Termékjellemzők (SPC)
26-03-2024

Aktív összetevők:

Neisseria meningitidis Group A polysaccharide 10ug (conjugated to tetanus toxoid); Neisseria meningitidis Group C polysaccharide 10ug (conjugated to tetanus toxoid); Neisseria meningitidis Group W135 polysaccharide 10ug (conjugated to tetanus toxoid); Neisseria meningitidis Group Y polysaccharide 10ug (conjugated to tetanus toxoid)

Beszerezhető a:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

Adagolás:

0.5 mL

Gyógyszerészeti forma:

Solution for injection

Összetétel:

Active: Neisseria meningitidis Group A polysaccharide 10ug (conjugated to tetanus toxoid) Neisseria meningitidis Group C polysaccharide 10ug (conjugated to tetanus toxoid) Neisseria meningitidis Group W135 polysaccharide 10ug (conjugated to tetanus toxoid) Neisseria meningitidis Group Y polysaccharide 10ug (conjugated to tetanus toxoid) Excipient: Sodium acetate Sodium chloride Tetanus toxoid Water for injection

Recept típusa:

Prescription

Terápiás javallatok:

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.

Termék összefoglaló:

Package - Contents - Shelf Life: Vial, glass, Glass vial (0.5 ml volume) closed with rubber stopper and flip-off seal - 1 dose units - 48 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, Glass vial (0.5 ml volume) closed with rubber stopper and flip-off seal - 10 dose units - 48 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)

Engedély dátuma:

2021-01-27

Betegtájékoztató

                                MenQuadfi
1
MENQUADFI®
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-135 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 to affect you
                                
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Termékjellemzők

                                Property of the Sanofi group - strictly confidential
menq-ccdsv4-5-dsv6-14mar24
Page 1 of 27
NEW ZEALAND DATA SHEET
1
PRODUCT NAME
MenQuadfi® (meningococcal (groups A, C, Y, W) polysaccharide tetanus
toxoid conjugate
vaccine) solution for injection
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.
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.
Primary Vaccination
•
Individuals 12 months of age and older receive a single dose.
Property of the Sanofi group - strictly confidential
menq-ccdsv4-5-dsv6-14mar24
Page 2 of 27
Booster Vaccination
•
MenQuadfi may be given as a single booster dose to adolescents and
adults who have
previously been primed with meningococcal vaccine at least 4 years
prior (see Section
5.1 Pharmacodynamic Properties).
Refer to official recommendations for further in
                                
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