MORBILVAX
REGISTRATION NUMBER:
28/30.1/0054
PROPRIETARY NAME
(and dosage form):
MORBILVAX
DESCRIPTIVE NAME OF MEDICINE:
Live, attenuated measles vaccine.
PHARMACOLOGICAL CLASSIFICATION:
A.30.1. BIOLOGICALS - ANTIGEN
SCHEDULING STATUS:
S2
COMPOSITION:
Each 0,5 mL dose contains no less than 1 000 CCID50 of attenuated Schwarz
strain of Measles virus, grown in chicken embryo cells, and no more than 50 mcg each
of neomycin B sulphate and kanamycin.
IDENTIFICATION:
Beige coloured freeze-dried residue in clear (single dose) or brown (10 dose) vials
sealed with rubber stopper and aluminium overseal. Reconstituted vaccine is yellow or
orange in colour.
PHARMACOLOGICAL ACTION OF THE MEDICINE:
For active immunisation against measles.
INDICATIONS:
Measles Virus Vaccine is recommended for active immunization against measles.
CONTRAINDICATIONS:
Morbilvax is contraindicated in the following conditions:
DOSAGE AND DIRECTIONS FOR USE:
DO NOT INJECT INTRAVENOUSLY.
Infants should receive two vaccinations, one at 9 months and another at
18 months. In high risk groups injections are advised at 6, 9 and 18 months.
Subsequent to vaccination immunization status of the infant should be checked, and
additional doses/vaccine must be given if necessary.
Reconstitute the vaccine with 0,5 mL (single dose) or 5 mL (ten dose) of diluent
supplied and shake gently to reconstitute vaccine.
Intramuscularly or subcutaneously inject 0,5 mL of reconstituted vaccine into the
outer aspect of the upper arm.
Reconstituted vaccine must be used immediately. Discard any unused vaccine.
SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Burning and/or stinging of short duration at the injection site, may occur.
Skin rash, Fatigue, respiratory symptoms, conjunctivitis, coryza, pharyngitis, cough,
encephalitis, fever, malaise and headache may occur.
Children exhibiting febrile convulsions have been reported.
Reactions at injection site: Allergic reactions such as a wheal and flare at the injection
site or urticaria have been reported.
Local reactions characterized by marked swelling, redness and vesiculation at the
injection site of attenuated live virus measles vaccines have occurred in children who
have previously received killed measles vaccine.
Vaccination should be postponed in patients suffering from any acute illness.
Due caution should be employed in administration of measles vaccine to children with a
history of febrile convulsions, or cerebral injury, or of any other condition in which
stress due to fever should be avoided. The physician should be alert to the temperature
elevation which may occur following vaccination.
It has been reported that attenuated measles virus vaccine (live), may result in a
temporary depression of tuberculin skin sensitivity. Therefore, if a tuberculin test is to
be done, it should be administered either before or simultaneously with Measles Virus
Vaccine.
Measures to treat anaphylaxis, including adrenalin should be available for immediate use
should an anaphylactoid reaction occur.
Use the reconstituted vaccine only if clear.
Vaccination should be deferred for at least three months following plasma or blood
transfusions, or administration of human serum globulin.
Use with other Live Virus Vaccines
There are no data available concerning simultaneous use of Measles Virus Vaccine with
monovalent or trivalent Poliovirus vaccine (live, oral), or with killed poliovirus
vaccines. However, serologic evidence shows that when Measles, Mumps, and Rubella Virus
Vaccine is given simultaneously with trivalent Poliovirus vaccine (live, oral), antibody
responses can be expected to be comparable to those which follow administration of the
vaccines at different times.
Other live virus vaccines should either be administered simultaneously (but at different
sites) or with an interval of at least three weeks between administrations.
After administration of Morbilvax an interval of at least 2 weeks should be observed
before administration of immunoglobulins.
Postpone vaccination for 3 months after receiving high-dose systemic corticosteroid
therapy, or for 6 months after receiving immunosuppressive therapy including
irradiation.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF TREATMENT:
See "Side effects and special precautions".
Treatment is symptomatic and supportive.
PRESENTATION:
a) | Single dose vaccine with 0,5 mL ampoule diluent |
b) | 10 x 1 dose vaccine plus 10 x 0,5 mL diluent |
c) | 10 x 10 dose vaccine plus 10 x 5 mL diluent |
STORAGE DIRECTIONS:
Freeze-dried vaccine must be stored in a dark place at +2°C to +8°C. Keep out of
reach of children. The reconstituted vaccine must be used immediately. Discard any unused
vaccine. Do not store reconstituted vaccine as there is no preservative present.
NAME AND ADDRESS OF APPLICANT:
Biovac SA c.c.
1 Manchester Road
Wadeville
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
April 1994
K/59 | L 12090 |