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Mencevax ACWY

SmithKline Beecham International - Pharmaceuticals [CPI Manufacturer]
Pregnancy Category B2
Use: Active immunisation against meningococcal meningitis

(groups A, C, W[135], Y) in adults, children > 2 years: close
contacts of patients with disease; travellers to epidemic countries;
epidemic control in confined communities

Contraindications: Severe acute febrile illness; IV admin.
Precautions: Impaired immune response; acute malaria;
pregnancy, lactation

Adverse Reactions: Local erythema, induration, pain;
lymphadenopathy; fever; URT illness; malaise; headache;
increased meningococcal carriage rates


Mencevax ACWY (Injection) Rx
Neisseria meningitidis vaccine
Neisseria meningitidis (meningococcus) groups A 50 mcg, C 50
mcg, W[135] 50 mcg and Y 50 mcg (purified polysaccharides)
per 0.5 mL; lyophilised; monodose vial; Gluten free.
Pack(s): 0.5 mL (+ solv.) .Fields[1]: $43.55

Dose: Adults, children > 2 years: 0.5 mL SCI; see MIMS
Annual

Composition
Active.

Each 0.5 mL dose of reconstituted vaccine contains 50
microgram of each of the polysaccharide of groups A, C,
W[135] and Y.

Inactive.
Solvent: isotonic sodium chloride solution.

Description
Mencevax ACWY is a lyophilised preparation of purified
polysaccharides from Neisseria meningitidis (meningococcus)
of groups A, C, W[135] and Y. It is presented as a white pellet
in a glass vial together with a separate vial of clear, colourless,
sterile saline solvent. When reconstituted with the solvent
supplied, the vaccine is ready for subcutaneous injection.

Actions
A single 0.5 mL dose of Mencevax ACWY elicits a significant
antibody response against each of group A and group C
meningococci in over 90% of adolescents and young adults,
lasting at least 12 months.

Responses to W[135] and Y meningococci appear to be equally
good, but have been less well studied. Fewer data are available
on response rates in children 2 to 13 years, and antibody
persistence may be shortened, especially in the two to four year
age group.

Although the clinical efficacy of the A or C components of the
vaccine has been demonstrated, there are currently no data
available on the protective efficacy of the antibody response to
group W[135] and Y polysaccharides.

Indications
Active immunisation against meningococcal meningitis caused by
group A, group C, group W[135] and group Y meningococci in
adults and children over two years.

The vaccine may be used for subjects who are close contacts of
patients with disease caused by meningococci of groups A, C
W[135] and Y; for travellers to countries where the disease is
endemic or highly epidemic; and for controlling epidemics of
infection caused by groups A, C, W[135] and Y meningococci in
confined communities.

Mencevax ACWY is not recommended for use in infants and
children under two years of age as antigenicity of the vaccine is
low in this age group and antibodies persist for shorter duration.

Contraindications
As with all vaccines, Mencevax ACWY is contraindicated in
subjects with severe acute febrile illnesses. However, the
presence of a trivial infection does not contraindicate vaccination.

The multidose presentations should not be used in subjects with
known systemic hypersensitivity to phenol.

Warnings
The vaccine gives no protection against meningococcal meningitis
caused by meningococci belonging to groups other than A, C,
W[135] and Y.

If administered to subjects with impaired immune responses, the
vaccine may not induce an effective response.

Immune response to the vaccine may be impaired after acute
malaria.

The use of Mencevax ACWY may increase the meningococcal
carriage rates, especially for meningococcal groups not included
in the vaccine.

Precautions
Mencevax ACWY is for subcutaneous use only: do not
administer intravenously.

Appropriate precautions should be taken to prevent the
transmission of any infectious agent.

No information is available concerning the effects of drugs,
intercurrent illnesses or other vaccines on the response to the
administration of Mencevax ACWY.

As with all injectable vaccines, a solution of adrenaline 1 in 1,000
should always be readily available for immediate injection in case
of rare anaphylactic reactions. For this reason, the vaccinee
should remain under medical supervision for 30 minutes after
vaccination.

Use in pregnancy.
(Category B2)

There is no convincing evidence of risk to the fetus from
immunisation of pregnant women using an inactivated bacterial
vaccine. However, there are no studies on the effect of the
purified polysaccharides contained in Mencevax ACWY on the
fetus. Therefore, the vaccine should not be given to pregnant
women unless the benefits to the mother clearly outweigh any
risks to the fetus.

Use in lactation.
No information is available on the safety of the use of Mencevax
ACWY during lactation.

Adverse Reactions
Mencevax ACWY may induce local and systemic reactions;
local reactions occur in the majority of adults and include
erythema, induration, tenderness or pain at the site of injection
and local axillary lymphadenopathy. Febrile reactions (> 38 deg.
C) and chills, which are less common, may appear within hours
of vaccination and may persist for 24 to 48 hours or longer.
Upper respiratory tract illness, headache and malaise occur
occasionally. A transient local immediate weal and flare reaction
and hypersensitivity reactions including anaphylactoid reactions
may occur rarely. Local and systemic adverse reactions,especially
 febrile reactions, may be encountered more frequently
in children than in adults.

Dosage and Administration
Mencevax ACWY should be reconstituted only with the saline
solvent supplied by adding the entire contents of the supplied vial
of solvent to the vaccine vial. The reconstituted vaccine should be
inspected for any foreign particulate matter and/or colouration
prior to administration. In the event of either being observed,
discard the vaccine.

The reconstituted vaccine should be administered subcutaneously
with a sterile syringe and needle. One dose of vaccine is contained in 0.5 mL.

Data on the persistence of antibody response are limited and the
optimal time for revaccination is not known at present. It appears
likely that the antibody response will last for at least one year,
possibly longer.

Presentation
Vials, with sterile saline as solvent: monodose.

Storage
Store lyophilised vaccine in a refrigerator at 2 to 8 deg. C or in a
freezer. Shelf life: 2 years.
The solvent can be stored at ambient temperatures.
After reconstitution, the vaccine should be injected promptly or
kept in a refrigerator. If it is not used within eight hours, it should
be discarded because of the risk of contamination.

It is recommended to protect the reconstituted vaccine from direct sunlight.

When supplies of Mencevax ACWY are distributed from a central cold store,
it is good practice to arrange transport under refrigerated conditions, particularly
 in hot climates.

Poisons Schedule
S4.

 

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