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Meningitis Vaccine Insert Information

CATEGORIES:

     Indications: Immunization, meningococcal meningitis

     Pregnancy Category C

     WHO Formulary

     FDA Pre 1938 Drugs

FDA DRUG CLASS: Vaccines/Antisera

BRAND NAMES: FSME-Immun (Austria, Germany); Mencevax ACWY (Bahrain, Cyprus,
Egypt, Iran, Iraq, Jordan, Kuwait, Lebanon, Libya, Oman, Qatar,
Republic-of-Yemen, Saudi-Arabia, Syria, United-Arab-Emirates); Menomune
(Australia); Menomune-A C Y W-135 (US);
(International brand names outside U.S. in italics)

 WARNING:
 For special instructions on use of Meningococcal Polysaccharide Vaccine,
 Groups A, C, Y and W-135 Combined, for Jet Injector Use. (see DOSAGE AND
 ADMINISTRATION)

DESCRIPTION:

Menomune, Meningococcal Polysaccharide Vaccine Groups, A, C, Y and W-135
Combined, is a freeze-dried preparation of the group-specific
polysaccharide antigens from Neisseria meningitidis , Group A, Group C,
Group Y and Group W-135 for subcutaneous use. The diluent is sterile
pyrogen-free distilled water to which thimerosal (mercury derivative)
1:10,000 is added as a preservative. After reconstitution with diluent as
indicated on the label, each 0.5 ml dose contains 50 mcg of "isolated
product" from each of Groups A, C, Y and W-135 in isotonic sodium chloride
solution preserved with thimerosal (mercury derivative). Each dose of
vaccine also contains 2.5 mg to 5 mg of lactose added as a stabilizer.1 The
vaccine when reconstituted is a clear colorless liquid.

THE VACCINE CONFORMS TO W.H.O. REQUIREMENTS.

CLINICAL PHARMACOLOGY:

N. Meningitidis: Causes both endemic and epidemic disease, principally
meningitis and meningococcemia. It is the second most common cause of
bacterial meningitis in the United States (approximately 20% of all cases),
affecting an estimated 3,000-4,000 people each year. The case-fatality rate
is approximately 10% for meningococcal meningitis and 20% for
meningococcemia, despite therapy with antimicrobial agents, such as
penicillin, to which all strains remain highly sensitive.2

Within the United States, serogroup B, for which a vaccine is not yet
available, accounts for 50%-55% of all cases; serogroup C, for 20%-25%; and
serogroup W-135, for 15%. Serogroups Y (10%) and A (1%-2%) account for
nearly all remaining cases. Serogroup W-135 has emerged as a major cause of
disease only since 1975. While serogroup A causes only a small proportion
of endemic disease in the United States, it is the most common cause of
epidemics elsewhere.2

A study performed using 4 lots of Meningococcal Polysaccharide Vaccine,
Groups A, C, Y and W-135 Combined in 150 adults showed at least a 4-fold
increase in bactericidal antibodies to all groups in greater than 90
percent of the subjects.3,4

A study was conducted in 73 children 2 to 12 years of age. Post-
immunization sera were not obtained on four children. Therefore, the
seroconversion rates were based on 69 paired samples Seroconversion rates
as measured by bactericidal antibody were: Group A - 72 percent, Group C -
58 percent, Group Y - 90 percent and Group W-135 - 82 percent.
Seroconversion rates as measured by a 2-fold rise in antibody titers based
on Solid Phase Radioimmunoassay were: Group A - 99 percent, Group Y - 97
percent and Group W-135 - 89 percent.5

As with any vaccine, vaccination with Meningococcal Polysaccharide Vaccine,
Groups A, C, Y and W-135 Combined may not protect 100% of susceptible
individuals.

Vaccine Efficacy: Numerous studies have demonstrated the immunogenicity and
clinical efficacy of the A and C vaccines. The serogroup A polysaccharide
induces antibody in some children as young as 3 months of age, although a
response comparable to that seen in adults is not achieved until 4 or 5
years of age; the serogroup C component does not induce a good antibody
response before age 18-24 months. The serogroup A vaccine has been shown to
have a clinical efficacy of 85%-95% and to be of use in controlling
epidemics.6 A similar level of clinical efficacy has been demonstrated for
the serogroup C vaccine, both in American military recruits and in an
epidemic. The group Y and W-135 polysaccharides have been shown to be safe
and immunogenic in adults and in children over 2 years of age; clinical
protection has not been demonstrated directly, but it assumed, based on the
production of bactericidal antibody, which for group C has been correlated
with clinical protection. The antibody responses to each of the four
polysaccharides in the quadrivalent vaccine are serogroup-specific and
independent.2

Duration of Efficacy: Antibodies against the group A and C polysaccharides
decline markedly over the first 3 years following a single dose of vaccine.
This antibody decline is more rapid in infants and young children than in
adults. Similarly, while vaccine-induced clinical protection probably
persists in schoolchildren and adults for at least 3 years, a recent study
in Africa has demonstrated a marked decline in the efficay of the group A
vaccine in young children over time. In this study, efficacy declined from
greater than 90% to less than 10% over 3 years in those under 4 years of
age at the time of vaccination; in older children, efficacy was still 67%,
3 years after vaccination.2,7

INDICATIONS AND USAGE:

Meningococcal Polysaccharide Vaccine, Groups A, C, Y and W-135 Combined, is
indicated for the following individuals:

     1. Persons 2 years of age and above in epidemic or endemic areas as
     might be determined in a population delineated by neighborhood,
     school, dormoitory, or the other resonable boundry. The prevalent
     serogroup in such a situation should match a serogroup in the vaccine.

     2. Individuals at particular high-risk to include persons with
     terminal component complement defiencies and those with anatomic or
     functional asplenia.

     3. Travelers to countries recognized as having hyperendemic or
     epidemic or epidemic disease such as the part of Sub-Saharan Africa
     known as the "meningitis belt", which extends from Mauritania in the
     west to Ethopia in the east.

Vaccinations also should be considered for household or institutional
contacts of persons with meningococcal disease as an adjunct to appropriate
antibiotic chemoprophlaxis as well as medical and laboratory personnel at
risk of exposure to meningcoccal disease.

This vaccine will not stimulate protection against infections caused by
organisms other than Groups A,C, Y and W-135 meningcococci.

CONTRAINDICATIONS:

Immunization should be deferred during the course of any acute illness.
Pregnant women should not be immunized since effects of vaccine on the
fetus are unknown.

IT IS A CONTRAINDICATIONS TO ADMINISTER MENOMUNE A/C/Y/W-135 TO INDIVIDUALS
KNOWN TO BE SENSITIVE TO THIMERSOAL OR AN OTHER COMPONENT OF THE VACCINE.

WARNINGS:

If the vaccine is used in persons receving immunosuppressive therapy, the
expected immune response may not be obtained.

PRECAUTIONS:
General

Epinephrine Injection (1:1000) must be immediately available to combat
unexpected anaphylactic or other allergic reactions.

Prior to an injection of any vaccine, all known precautions should be taken
to prevent side reactions. This includes a review of the patient's history
with respect to possible sensitivity to the vaccine or similar vaccines.

As with any vaccine, vaccination with Meningococcal Polysaccharide Vaccine,
Groups A, C, Y and W-135 Combined may not protect 100% of susceptible
individuals. Protective antibody levels may be achieved within 10-14 days
after vaccination.2

Special care should be taken to avoid injecting the vaccine intradermally,
intramuscularly, or intravenously since clinical studies have not been done
to establish safety and efficacy of the vaccine using these routes of
administration.

A seperate, sterile syringe and needle or a sterile disposable unit should
be used for each individual patient to prevent transmission of hepatitis
and other infections agents from one person to another.

During use it is possible that the nozzle of the Jet Injector Apparatis may
become contaminated with blood or serum. In one instance, such
contamination has been reported to be associated with transmission to
hepatits b disease. Therefore, if blood or serum contamination occurs, the
nozzle should be disassembled, cleansed and sterilized before continued use
to prevent the possibility of transmission of hepatitis or other infectious
agents from one person to another.8

Pregnancy 9

Pregnancy Category C: Animal reproduction studies have not been conducted
with Meningcoccal Polysaccharide Vaccine, Groups A, C, Y and W-135. It is
also not known whether Meningococcal Polysaccharide Vaccine, Groups A, C, Y
and W-135 can cause fetal harm when administered to a pregnant woman or can
affect reproduction capacity.

Experience in Humans: There is no data on the safety of Menomune when
administered to a pregnant woman. Therefore, Menomune should not be
administered to a pregnant woman, particularly in the first trimester.

Pediatric Use: THERE ARE NO DATA ON SAFETY AND EFFICACY OF MENOMUNE WHEN
ADMINISTERED TO CHILDREN UNDER 2 YEARS OF AGE.

ADVERSE REACTIONS:

Adverse reactions to meningococcal vaccine are mild and infrequent,
consisiting of localized erythema lasting 1-2 days. Up to 2% of young
children develop fever transiently after vaccination.2

As with the administration of any vaccine, one should expect possible
hypersensitivity reactions.

DOSAGE AND ADMINISTRATION:

Parental drug products should be inspected visually for extraneous
particulate matter and/or discoloration prior to administration whenever
solution and container permit. If these conditions exist, vaccine should
not be administered.

Reconstitute the vaccine using only the diluent supplied for this purpose.
Draw the volume of diluent shown on the diluent label into a suitable size
syringe and inject into the vial containting the vaccine. Shake vial until
the vaccine is dissolved. Administer the vaccine subcautaneously.

The immunizing dose is a single injection of 0.5 ml given subcutaneously.

Primary Immunization: For both adults and children, vaccine is administered
subcutaneously as a single 0.5 ml dose. The vaccine can be given at the
samt time as other immunizations, if needed. Protective antibody levels may
be achieved within 10-14 days after vaccination.2

Revaccination: Revaccination may be indicated for individuals at high risk
of infection, particularly children who were first immunized under 4 years
of age; such children should be considered for revaccination after 2 or 3
years if they remain at high risk. The need for revaccination in older
children and adults remains unknown.2

 Special instructions for 50 dose Vial of Meningococcal Polysaccharide
 Vaccine, Groups A, C, Y and W-135 Combined, for Jet Injector Use.

 DOSAGE AND ADMINISTRATION: Parenteral drug products should be inspected
 visually for extraneous particulate matter and/or discoluration prior to
 administration whenever solution and container permit. If these
 conditions exist, vaccine should no tbe administered. Using a suitable
 syringe and needle and aseptic precautions, transfer the volume of
 diluent shown on the diluent label into the vial containing the vaccine.
 Shake vial until the vaccine is dissolved. Administer ONLY with automatic
 hypodermic jet apparatus. 50 DOSE VIAL NOT TO BE UTILIZED IN NEEDLE AND
 SYRINGE METHOD OF IMMUNIZATION. If absolutely necessary, syringes and
 beedles may be used with such containers with caution. However, due to
 coring of the stopper do NOT insert needle into vial more than 20 times.
 Discard partially used vial of vaccine. Immunization consists of a single
 injection of 0.5 ml given subcutaneously. Special care should be taken
 The immunizing dose is a single injection of 0.5 ml given subcutaneously.
 Special care should be taken to avoid injecting the vaccine
 intradermally, intramuscularly, or intravenously by using the deltoid
 area, since clinical studies have not been done to establish the safety
 and efficacy of the vaccine using these routes of administration.

 Caution: During use it is possible that the nozzle of the Jet Injector
 Apparatus may become contaminated with blood or serum. In one instance,
 such contamination has been reported to be associated with the
 transmission of hepatitis b disease. Therefore, if blood or serum
 contamination occurs, the nozzle should be disassembled, cleansed and
 sterilized before continued use to prevent the possibility of
 transmission of hepatitis or other infectious agents from one person to
 another.8

REFERENCES:
1. Tiesjema RH, et al. Enhanced stability of meningococcal polysaccharide
vaccines by using lactose as a menstruum for lyophilization. Bull WHO
55;43-47, 1977.
2. Recommendation of the Immunization Practices Advisory Committee (ACIP).
Meningcoccal Vaccines. MMWR 34: 255-259, 1985.
3. Hankins, W.A., et al: Clinical ands serological evaluation of a
meningococcal polysaccharide vaccine goups A, C, Y and W-135. proc Soc
Exper Biol Med 169: 54-57, 1982.
4. Lepow, M.L., et al: Reactogenicity and immunogenicity of a quadrivalent
combined meningcoccal polysaccharide vaccine in children, J. Infect Dis
154: 1033-1036, 1986,
5. Unpublished data available from Connaught Laboratories, Inc., complied
1982.
6. Peltola, H., et al: Clinical efficacy of meningococcus Group A capsular
polysaccharide vaccine in children three months to five years of age. N
Engl J. Med 297: 686-691, 1977.
7. Reingold, A. L., et al: Age-specific differences in duration of clinical
protection after vaccination with meningococcal polysaccharide A vaccine.
Lancet. No. 8447: 114-118, 1985. 8. CDC. Hepatitis B associated with jet
gun injection - California. MMWR 35: 373-376, 1986.
9. Code of Federal Regulations. 21CFR201.57 (f) (6) (c), 1989.
  ------------------------------------------------------------------------

HOW SUPPLIED:

Vial, 1 Dose, with 0.78 ml vial of diluent.
Vial, 10 Dose, with 6 ml vial of diluent, for administration with needle
and syringe (may be used with jet injector although the desired number of
doses may not be obtained).
Vial, 50 Dose, with 27.5 ml vial of diluent for JET INJECTOR USE ONLY.
Additional package sizes available on speical order.
Storage: Store freeze-dried vaccine and reconstituted vaccine, when not in
use between 2 - 8C (35 - 45F). Discard remainder of multidose vials of
vaccine within 5 days after reconstitution. The single dose vial should be
used within 24 hours of reconstitution.

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April 5, 2008

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