-------------------------------------------------------------------------------------------------------------------

Composition
1 dose of 0.5 ml contains

-Measles virus, Edmonston – Zagreb, HDC                    not less than 1000 CCID50
-Mumps virus, L-Zagreb, CF                                         not less than 5000 CCID50
-Rubella virus, RA27/3, HDC                                         not less than 1000 CCID50

 Inactive ingredients

-Sorbitol, gelatine, L-arginine HCI, maltose, sodium chloride, lactalbumin hydrolysate, L-alanine.

-------------------------------------------------------------------------------------------------------------------

Properties
The vaccine is prepared by propagation of live attenuated viruses; measles (Edmonston – Zagreb strain) and rubella virus (RA27/3 strain) grown in human diploid cells (HDC) and mumps (L-Zagreb strain) grown in cell cultures of chick fibroblasts (CF) derived from chick embryo of specified pathogen free flocks (SPF).

Lyophilized vaccine is dissolved with water for injection provided. Due to small differences in pH values, the dissolved vaccine is a clear yellow to clear pink.

The production and control of measles, mumps and rubella vaccine (live) complies to the respective monograph of current European Pharmacopoeia.

-------------------------------------------------------------------------------------------------------------------

Indications
The vaccine is indicated for active immunization against measles, mumps and rubella the vaccine should be used at an age when passive protection through the mothers antibodies is lost in children, the immunization against measles, mumps and rubella should be obligatory, indicated in children at twelve months of age or older. Immunization is also indicated in children up to 18 months of age or older, if they have not received immunization against these diseases. The second dose of MMR vaccine should be routinely administered at the age of 6 to 7 years.

Persons with history of measles, mumps and rubella are also subject to immunization.

-------------------------------------------------------------------------------------------------------------------

Contraindications

-pregnancy;

-acute infectious diseases;

-febrile state;

-immune deficiency; primary (congenital) and secondary (caused by a malignant disease or drug use such as antimetabolites, corticosteroids, alkylating agents and radiations);

-with in three moths following blood plasma transfusion, or immunoglobulin therapy (or after even longer period, if greater doses have been used), i .e.  Within six months after exsanguinotransfusion;

-hypersensitivity to vaccine ingredients;

Although grown in primary culture of chick fibroblasts, there is no evidence of allergic reactions in immunized persons allergic to chicken or chicken feathers. Diarrhoea or benign acute diseases of the upper respiratory tract, as well as seropositivity to HIV are not contraindicated to vaccination against measles, mumps and rubella.

-------------------------------------------------------------------------------------------------------------------

Precautions

-a through case history should precede immunization

-in case the vaccinations have not been administered at the same time, a period of at least one month should expire between two immunizations with live virus vaccines

-tuberculin skin tests (Mantoux test) should be done before, or least 2 months after administration of measles, mumps and rubella vaccine, because of a possible occurrence of a transient inhibition of cellular immunity

-children prone to infectious disease should be immunized, like in asthma, cystic fibrosis, celiac disease, chronic lung disease congenital heart diseases, Down’s syndrome, stable neurological conditions, malnutrition, as well as premature infants regardless of the degree of prematurity

-Antishock therapy should be used in case possible anaphylactic reaction!

-------------------------------------------------------------------------------------------------------------------

Pregnancy an lactation
The vaccine must not be used in pregnancy. Conception should be avoided for two months after vaccination, because of the presence of the virus in the body. As the excretion of the active substances (viruses) in the milk has been described in the literature, the vaccination during lactation should be avoided.

-------------------------------------------------------------------------------------------------------------------

Adverse effects

Local
Transient pain and irritation (edema, indurations and erythema) at the site of injection

General
The most frequent reaction to vaccination with live attenuated morbilla virus are increased body temperature following approximately one week after vaccination and skin rash.. increased body temperature, parotid swelling and skin rash appear in rear cases as reactions to the mumps component adds side effects to rubella components, arthralgia and arthritis appear to be associated with the age of the immunized persons, that is they are reported in up to 2% of girls 6 to 12 and 13 to 16 years of age, in relation to 25% of girls and women 20 to 24 years of age.

There are data available in relation to the incidents of side effects upon the administration of the second dose of vaccine; a higher risk of side effects is recorded in the age group of 11 to 12 years than in the age group 6 to 7 years of age.

-------------------------------------------------------------------------------------------------------------------

Dosage and administration

The lyophilized vaccine should be diluted immediately prior to use!

0.5 ml water for injection should be taken as diluents for one dose of vaccine.

2.5 ml water for injection should be taken as diluents for five doses of vaccine.

A certain amount of diluents should be withdrawn via a sterile needle into the sterile syringe. To obtain a prescribed suspension the diluents should be injected into a vial of lyophilized vaccine and agitated gently in order to avoid the formation of foam. In multiple dose vial, a new sterile needle and the syringe should be used for each (0.5 ml) per dose

The vaccine should be heated to body temperature prior to vaccination (by holding in closed fist); the vaccine should not come into contact with disinfectants.

The usual 0.5 ml dose should be injected subcutaneously into the upper arm in the region of the deltoid muscle.

From the microbiological point of view the reconstituted vaccine should be used as soon as possible. Should the vaccine not be used immediately the person administering the vaccine should be responsible for its proper storage and labeling. Reconstituted vaccine should be kept at temperatures between 2 and 8^o C and used within 8 hours, expect instances where the vaccine has been opened and dissolved in controlled and validated aseptic conditions.

-------------------------------------------------------------------------------------------------------------------

Drug interactions
Vaccine against measles, mumps and rubella may be used simultaneously with other live virus vaccines, (vaccine against polio, hepatitis B and yellow fever) and bacterial vaccines in vaccines against diphtheria, tetanus and Pertussis).  Other commercially individual vaccines should not be mixed in the same syringe in the measles, mumps and rubella vaccine (expanded program of immunization of the world health organization)   

-------------------------------------------------------------------------------------------------------------------

Storage
Store the vaccine at 2 to 8^o C protected from light.

-------------------------------------------------------------------------------------------------------------------

Shelf-life
The expiry dated of the vaccine is indicated on the package.

-------------------------------------------------------------------------------------------------------------------

Presentation
-50 vials with as 5 doses of vaccine in a box and 50 ampoules with 2.5 of water for injection in a box.