ACWY Vax - powder and solvent for solution for injection Meningococcal polysaccharide groupsA, C, Y and W135 vaccine

Land: Malta

Språk: engelska

Källa: Medicines Authority

Aktiva substanser:

NEISSERIA MENINGITIDIS, POLYSACCHARIDE GROUP, MENINGOCOCCAL POLYSACCHARIDE, GROUP W

Tillgänglig från:

Smithkline Beecham Limited 980, Great West Road, Brentford Middlesex TW8 9GS, United Kingdom

ATC-kod:

J07AH04

INN (International namn):

NEISSERIA MENINGITIDIS POLYSACCHARIDE GROUP C 50 µg MENINGOCOCCAL POLYSACCHARIDE GROUP W-135 50 µg

Läkemedelsform:

POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Sammansättning:

NEISSERIA MENINGITIDIS POLYSACCHARIDE GROUP C 50 µg MENINGOCOCCAL POLYSACCHARIDE GROUP W-135 50 µg

Receptbelagda typ:

POM

Terapiområde:

VACCINES

Bemyndigande status:

Withdrawn

Tillstånd datum:

2008-09-30

Bipacksedel

PAGE 1 OF 6
PACKAGE LEAFLET
PAGE 2 OF 6
PACKAGE LEAFLET: INFORMATION FOR THE USER
ACWY VAX POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
Meningococcal polysaccharide groups A, C, Y and W
135
vaccine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD START
RECEIVING THIS VACCINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This vaccine has been prescribed for you or your child only. Do not
pass it on to others.

If you or your child get any side effects, talk to your doctor or
pharmacist. This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What ACWY Vax is and what it is used for
2.
What you need to know before you or your child receive ACWY Vax
3.
How ACWY Vax is given
4.
Possible side effects
5.
How to store ACWY Vax
6.
Contents of the pack and other information
1.
WHAT ACWY VAX IS AND WHAT IT IS USED FOR
ACWY Vax is a vaccine used in children older than 2 years, adolescents
and adults to prevent
disease caused by the bacteria named “_Neisseria meningitidis_
groups A, C, W
135
and Y”. These
bacteria are highly contagious and can cause serious and sometimes
life-threatening infections such
as meningitis (infection around the brain or spinal cord) or
septicaemia (blood poisoning). These
diseases may be followed by permanent disabilities.
The vaccine works by causing the body to produce its own protection
(antibodies) against these
bacteria.
This vaccine contains purified parts of the bacteria _Neisseria
meningitidis_ (groups A, C, W
135
and
Y). None of the components in the vaccine are infectious.
ACWY Vax will only protect against infections caused by the _Neisseria
meningitidis_ groups A, C,
W
135
and Y for which the vaccine has been developed.
As with all vaccines, ACWY Vax may not fully protect all people who
are vaccinated.
2.
WHAT YOU NEED TO KNOW BEFORE YOU OR YOUR CHILD RECEIVE ACWY VAX
ACWY VAX SHOULD

Produktens egenskaper

PAGE 1 OF 12
SUMMARY OF PRODUCT CHARACTERISTICS
PAGE 2 OF 12
1.
NAME OF THE MEDICINAL PRODUCT
ACWY Vax - powder and solvent for solution for injection Meningococcal
polysaccharide groups
A, C, Y and W
135
vaccine
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
After reconstitution, 1 dose (0.5 ml) contains:
_Neisseria meningitidis_ group A polysaccharide
50 µg
_Neisseria meningitidis _group C polysaccharide
50 µg
_Neisseria meningitidis_ group Y polysaccharide
50 µg
_Neisseria meningitidis_ group W
135
polysaccharide
50 µg
Excipients with known effect:
This product contains sodium 77 micromol per dose (see section 4.4).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
The powder is white. The solvent is clear and colourless.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Active immunisation of children older than 2 years, adolescents and
adults against invasive
meningococcal disease caused by meningococci of groups A, C, W
135
and Y.
ACWY Vax should be used in accordance with available official
recommendations.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
One dose of 0.5 ml.
Subjects who remain at increased risk of invasive meningococcal
disease may be revaccinated at
intervals (see persistence of immune response in section 5.1).
Intervals should be in accordance
with available official recommendations.
_Paediatric population _
_ _
The safety and efficacy of ACWY Vax in children up to 2 years of age
have not been established.
PAGE 3 OF 12
Method of administration
For instructions on reconstitution of the medicinal product before
administration, see section 6.6.
ACWY Vax is for deep subcutaneous injection only.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substances or to any of the excipients
listed in section 6.1.
Hypersensitivity after previous administration of ACWY Vax .
As with other vaccines, the administration of ACWY Vax should be
postponed in subjects
suffering from acute severe febrile illness. The presence of a mi