Source: Health Products Regulatory Authority (ZA) Revision Year: 2024 Publisher: MSD (Pty) Ltd, 117 16 th Road, Halfway House, 1685, South Africa
ONVARA lyophilised powder and solvent for suspension for injection.
| Pharmaceutical Form |
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Powder: Lyophilised, white, compact crystalline pellet. Reconstituted vaccine suspension: ONVARA, when reconstituted, is a clear, colourless to pale yellow liquid, free from visible particulate matter. |
Each 0,5 ml dose contains: a minimum of 1 350 PFU (plaque forming units) of Oka/Merck (live, attenuated) varicella virus when reconstituted.
The product also contains residual components of MRC-5 cells and trace quantities of neomycin and bovine calf serum from MRC-5 culture media.
The product contains no preservative.
ONVARA contains sucrose.
Excipients: For the full list of excipients, see section 6.1.
| Active Ingredient |
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Natural infection induces a cellular and humoral immune response to the varicella-zoster virus, which can be rapidly detected following infection. IgG, IgM and IgA directed against viral proteins usually appear at the same time that a cellular immune response can be demonstrated, making the relative contribution of humoral and cellular immunity to disease progression difficult to ascertain. Vaccination has been shown to induce both humoral and cell-mediated types of immunity. |
| List of Excipients |
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Inactive ingredients: Powder: Anhydrous disodium phosphate Solvent: Water for Injections |
Vial: 3 ml clear Type 1 borosilicate glass vial with a grey rubber stopper and a silver aluminium cap with 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 flip-off cap. 3 ml vial of ONVARA and 3 ml vial of DILUENT is 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
48/30.2/1059
25 November 2016
| Drug | Countries | |
|---|---|---|
| ONVARA | South Africa |
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