MENQUADFI SOLUTION

Krajina: Južná Afrika

Jazyk: angličtina

Zdroj: South African Health Products Regulatory Authority (SAHPRA)

Dostupné z:

Sanofi-Aventis South Africa (Pty) Ltd

Dávkovanie:

10 μg & 55 μg

Forma lieku:

SOLUTION

Zloženie:

EACH 0,5 ml SOLUTION CONTAINS Neisseria meningitidis group A polysaccharide 10,0 μg Neisseria meningitidis group C polysaccharide 10,0 μg Neisseria meningitidis group Y polysaccharide 10,0 μg Neisseria meningitidis group W polysaccharide 10,0 μg TETANUS TOXOID carrier protein 55,0 μg

Stav Autorizácia:

Registered

Príbalový leták

2023/09/19
Signed:
Page 1 of 8 PATIENT INFORMATION LEAFLET
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SCHEDULING STATUS
S4
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4
M
ENQUADFI (SOLUTION FOR INJECTION)
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Meningococcal (Groups A, C, Y, W) Polysaccharide Tetanus Toxoid
Conjugate Vaccine
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7
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD IS
VACCINATED, BECAUSE IT CONTAINS
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IMPORTANT INFORMATION FOR YOU.
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•
Keep this leaflet. You may need to read it again.
10
•
Do not share MenQuadfi with any other person.
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•
Ask your health care provider or pharmacist if you need more
information or advice.
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•
If you or your child get any side effects, talk to your doctor,
pharmacist, or nurse. This includes
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any possible side effects not listed in this leaflet. See section 4.
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WHAT IS IN THIS LEAFLET
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1.
What MenQuadfi is and what it is used for
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2.
What you need to know before you or your child are given MenQuadfi
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3.
How MenQuadfi is given
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4.
Possible side effects
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5.
How to store MenQuadfi
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6.
Contents of the pack and other information
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1.
WHAT MENQUADFI IS AND WHAT IT IS USED FOR
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WHAT MENQUADFI IS USED FOR
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MenQuadfi is a vaccine that can be given to children from 1 year of
age, adolescents and adults.
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MenQuadfi helps to protect against infections caused by a type of
types bacteria (germs) called
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2023/09/19
Signed:
Page 2 of 8
“_Neisseria meningitidis”, _specifically against A, C, W and Y.
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_Neisseria meningitidis_ bacteria (also called meningococci)_ _can be
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threatening infections, such as:
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•
Meningitis – an inflammation of the tissues that surround the brain
and spinal cord;
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•
Septicaemia – an infection of the blood.
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Both infections can result in serious disease with long lasting
effects or possibly death.
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MenQuadfi should be used in accordance with official national
guidelines.
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HOW THE VACCINE WORKS
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MenQuadfi works by stimulating the vaccinated person natural defense
(immune system), to
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produce protective antibodies against the bacteria.
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MenQuadfi only helps to protect against illnesses caused

Súhrn charakteristických

2023/09/19
Signed:
Page 1 of 19 PROFESSIONAL INFORMATION FOR MENQUADFI
1
SCHEDULING STATUS:
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S4
3
4
1.
NAME OF THE MEDICINE
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MenQuadfi (solution for injection)
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Meningococcal (Groups A, C, Y, W) Polysaccharide Tetanus Toxoid
Conjugate Vaccine.
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2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
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COMPOSITION PER 0,5 ML DOSE:
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Active substance:
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_Neisseria meningitidis_ group A polysaccharide
1
10 micrograms
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_Neisseria meningitidis_ group C polysaccharide
1
10 micrograms
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_Neisseria meningitidis_ group Y polysaccharide
1
10 micrograms
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_Neisseria meningitidis_ group W polysaccharide
1
10 micrograms
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1
Conjugated to tetanus toxoid carrier protein
55 micrograms
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For the full list of excipients, see section 6.1.
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3.
PHARMACEUTICAL FORM
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Solution for injection.
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Clear colourless solution.
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4.
CLINICAL PARTICULARS
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4.1
THERAPEUTIC INDICATIONS
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MenQuadfi is indicated for active immunisation of individuals from the
age of 12 months and older
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against invasive meningococcal disease caused by _Neisseria
meningitidis_ serogroups A, C, W,
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and Y.
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The use of this vaccine should be in accordance with available
official recommendations.
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4.2
POSOLOGY AND METHOD OF ADMINISTRATION
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POSOLOGY
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Primary vaccination:
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•
Individuals 12 months of age and older: One single dose (0,5 mL).
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Booster vaccination:
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•
A single 0,5 mL dose of MenQuadfi may be used to boost subjects who
have previously
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received a meningococcal vaccine containing the same serogroups (see
section 5.1).
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•
Long-term antibody persistence data following vaccination with
MenQuadfi are available up to
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7 years after vaccination (see sections 4.4 and 5.1).
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_OTHER PAEDIATRIC POPULATION _
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The safety and immunogenicity of MenQuadfi in individuals under 12
months of age have not yet
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been established.
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METHOD FOR ADMINISTRATION
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For intramuscular injection only, preferably in the deltoid region or
anterolateral thigh depending on
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the recipient's age and