Source: Health Products Regulatory Authority (ZA) Revision Year: 2020 Publisher: MSD (Pty) Ltd, 117 16 th Road, Halfway House, 1685, South Africa
OMZYTA Powder and Solvent for Suspension for Injection
(Measles, Mumps and Rubella Virus Vaccine Live)
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Powder: Before reconstitution, the lyophilised vaccine is a light yellow compact crystalline plug. Reconstituted solution: OMZYTA, when reconstituted, is a clear yellow solution. Diluent: Clear, colourless liquid. |
When reconstituted as directed, the dose for injection is 0,5 mL and contains not less than 1 000 CCID50 (50% cell culture infectious dose) of measles virus, 12 500 CCID50 of mumps virus and 1 000 CCID50 of rubella virus.
| Active Ingredient |
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Rubella virus vaccine contains live attenuated rubella virus, produced in human diploid (MRC-5) cells. It is a virus vaccine for active immunization against rubella that is subcutaneously administered. |
| List of Excipients |
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Sorbitol, sodium phosphate, sucrose, hydrolysed gelatin, recombinant human albumin, foetal bovine serum, other buffer and media ingredients and approximately 25 µg of neomycin. The product contains no preservative. Diluent: Water for injection. |
Vial Powder: 3 mL clear Type 1 borosilicate glass vial with a grey stopper (butyl rubber) and a blue plastic cap.
Sterile Diluent Vial: 0,7 mL water for injection in a 3 mL glass vial with grey rubber stopper and dark grey plastic flipoff cap.
Carton: 3 mL vial of OMZYTA and 3 mL vial of DILUENT are packed together in a cardboard carton with the package insert and patient information leaflet.
Pack sizes of 1 or 10 vials.
Not all pack sizes may be marketed.
MSD (Pty) Ltd, 117 16th Road, Halfway House, 1685, South Africa
50/30.2/0576
29 September 2017
| Drug | Countries | |
|---|---|---|
| OMZYTA | South Africa |
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