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:

– Allergy to neomycin and/or kanamycin
– Acute febrile illness.
– Patients receiving high dose systemic therapy with ACTH, corticosteroid therapy, receiving immunosuppression therapy including irradiation, alkylating agents or antimetabolites; or suffering from malignant conditions such as leukemia or lymphomas. Hodgkins disease or other tumours of the reticuloendothelial system.
– Primary immuno-deficiency states.
– Allergy to eggs, chicken or chicken feathers
– Individuals who are pregnant, or plan to become pregnant within three months following vaccination.

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

http://home.intekom.com/pharm/biovac/morbilvx.html