Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2014 Publisher: Bio Products Laboratory Limited, Dagger Lane, Elstree, Hertfordshire, WD6 3BX, United Kingdom Tel: +44 (0)20 8957 2200 Fax: +44 (0)20 8957 2608 Email: info@bpl.co.uk
Human Rabies Immunoglobulin, not less than 150 IU/mL solution for injection.
| Pharmaceutical Form |
|---|
|
Solution for injection. |
Human Rabies Immunoglobulin contains human protein, 40-180 g/L of which at least 95% is IgG. The concentration of specific IgG to Rabies virus is not less than 150 IU/mL in nominal 500 IU vials. The correct volume to give the stated potency is overprinted on the label.
This product is prepared from plasma from screened donors. Donors are selected from the USA.
For excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Human rabies immunoglobulin |
Human rabies immunoglobulin contains mainly immunoglobulin G (IgG) with a specifically high content of antibodies against rabies virus. Human Rabies Immunoglobulin must always be used in combination with a rabies vaccine. |
| List of Excipients |
|---|
|
Sodium chloride |
Neutral borosilicate glass vial (type I Ph.Eur.) with overseal consisting of a halobutyl rubber wad (type I Ph.Eur.), clear lacquered aluminium skirt and flip-off polypropylene cap.
Bio Products Laboratory Limited, Dagger Lane, Elstree, Hertfordshire, WD6 3BX, United Kingdom
Tel: +44 (0)20 8957 2200
Fax: +44 (0)20 8957 2608
Email: info@bpl.co.uk
PL 08801/0014
February 1992
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