DIPLOVAX HDC 4.0

PROPRIETARY NAME
(and dosage form):

DIPLOVAX HDC 4.0

DESCRIPTIVE NAME OF MEDICINE:
Freeze-dried measles vaccine produced from the Edmonston-Zagreb strain which has been further attenuated in human diploid cells.

REGISTRATION NUMBER:
Y/30.1/246

PHARMACOLOGICAL CLASSIFICATION:
A. 30.1. Biologicals –Antigen

SCHEDULING STATUS:
S2

COMPOSITION:
The vaccine contains live, attentuated measles virus of the Edmonston-Zagreb strain, propagated in human diploid cells. Each dose of 0,5 mL contains at least 104 CCID50 (cell culture infective doses) of live measles virus. The vaccine is stabilized with a 10% gelatin-sorbitol stabiliser. The freeze-dried vaccine is reconstituted with 0,5 mL Sterile Water for Injections per dose.

IDENTIFICATION:
Cream-coloured freeze-dried powder which forms a light-pink solution within 30 seconds of dissolving in Sterile Water for Injections.

PHARMACOLOGICAL ACTION OF THE MEDICINE:
The attenuated Edmonston-Zagreb strain of measles virus vaccine produces a modified measles infection in the susceptible host. The vaccine is highly immunogenic. A single dose injected subcutaneously has been shown to produce a two to fourfold rise in antibody titres when tested with haemaggutination-inhibition test in 95,4% of susceptible children. On the other hand, the incidence of side-effects is very low and the vaccine is extremely well tolerated. In epidemiological studies the protection factor obtained by Diplovax HDC 4.0 is 96,4%. Clinical trials conducted in both developed and underdeveloped communities have confirmed this vaccine's efficacy.

INDICATIONS:
The vaccine is recommended for active immunization against measles in children at the age of 9 months. A booster dose is recommended at 18 months. The decision to re-vaccinate must be based on evaluation of each individual case.

CONTRA-INDICATIONS:
Any febrile illness, including respiratory diseases; Acute infectious diseases; Leukaemia, Lymphomas, severe anaemia and other severe diseases of the haematopoietic system; Severe impairment of the renal function; Decompensated heart diseases; Known hypersensitivy to any component listed under the composition above; Immunosuppression due to any cause, including congenital immune deficiency states, radiotherapy or cytostatic, ACTH or corticosteroid drugs; Immunosuppression following organ transplantation; Diseases and disorders of the central nervous system; Pregnancy; Pregnancy should be avoided for 3 months following vaccination; Active, untreated tuberculosis.

DOSAGE AND DIRECTIONS FOR USE:
Each dose is 0,5 mL and is the same for all patients.
The freeze-dried vaccine is reconstituted with 0,5 mL Sterile Water for Injections per dose.
(Single dose vial: 0,5 mL, Five dose vial: 2,5 mL, Ten dose vial: 5,0 mL). The product may only be used if the reconstituted solution is clear.
A sterile syringe and needle, free of preservatives, antiseptics and detergents in order to avoid inactivation of the live virus should be used. The entire quantity of sterile water for injections is drawn into the syringe and is injected into the ampoule/vial containing the freeze-dried virus. The Virus particles dissolve within 30 seconds and should be agitated to ensure thorough mixing. The site chosen for injection must be suitably cleaned. The reconstituted vaccine is administered subcutaneously into the outer aspect of the upper arm using a new needle. DO NOT INJECT INTRAVENOUSLY.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects are mild and the vaccine is well tolerated by most children. A rise in body temperature may occur in 20% of children, but the mean value of the fever is only 38.0C. Most temperatures appear 1 day after vaccination and resolve by the 4th day. Other side-effects include conjunctivitis (17,4%), loss of appetite (18,1%), indisposition (8%), rash (6,5%) and malaise (5,7%). Diplovax HDC 4,0 may be administered simultaneously with monovalent or trivalent poliovirus vaccine, mumps vaccine and rubella vaccine. Care must be taken to avoid intravenous administration of the vaccine. Adrenalin should be available for immediate use in the event of an anaphylactic reaction. Caution should be employed in the administration of measles vaccine to children with a history of febrile convulsions and the rise in temperature must be monitored in such patients. Immunization should be deferred for at least three months following blood or plasma transfusions or after administration of human immune serum globulin. It has been reported that attenuated measles virus vaccine may result in a temporary depression of the tuberculin skin test.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See Side-Effects and Special precautions. Treatment is symptomatic and supportive.

PRESENTATION:

a) Single dose vaccine vial which must be reconstituted with a 0,5 mL ampoule of Sterile Water for Injections.
b) Five dose vaccine vial which must be reconstituted with a 2,5 mL ampoule of Sterile Water for Injections.
c) Ten dose vaccine vial which must be reconstituted with a 5,0 mL ampoule of Sterile Water for Injections.

 

STORAGE DIRECTIONS:
The freeze-dried vaccine must be stored in a dark place (sunlight can inactivate the live virus) at +2C to +8C.
Keep out of reach of children. The reconstituted vaccine must be used within eight hours. Discard any unused portion after eight hours.

NAME AND ADDRESS OF APPLICANT:
Biovac S.A. c.c., 1 Manchester Rd, WADEVILLE, South Africa.

DATE OF PUBLICATION OF PACKAGE INSERT:
December 1994.

L/94 L12081