Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Bio Products Laboratory Ltd., Elstree, WD6 3BX, United Kingdom
Human Varicella-Zoster Immunoglobulin 100 IU/ml solution for injection.
| Pharmaceutical Form |
|---|
|
Solution for injection. The colour can vary from a colourless to pale yellow sterile solution (see section 6.6). |
Human varicella-zoster immunoglobulin.
Human protein content 40-180 g/l of which at least 95% is IgG.
Each vial contains 250mg human varicella-zoster immunoglobulin.
One ml contains 100 IU/ml human varicella immunoglobulin.
The maximum IgA content is 540 micrograms/ml.
Distribution of the IgG subclasses (approximate values):
IgG1 64.3%
IgG2 29.0%
IgG3 6.2%
IgG4 0.5%
Produced from the plasma of human donors.
Excipient with known effect:
Sodium content: This medicinal product contains not more than 10 mg (0.5 mmol) sodium per 250 mg therefore it is essentially ‘sodium-free’.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Human varicela zoster immunoglobulin |
Human varicella zoster immunoglobulin contains mainly immunoglobulin G (IgG) with a specifically high content of antibodies against varicella-zoster virus. It is used for prophylaxis against varicella zoster virus (VZV) infection. |
| List of Excipients |
|---|
|
Sodium chloride |
5 ml glass vial (Type I Ph.Eur.) closed with a halobutyl stopper and over-sealed with a tamper-evident cap.
Vials are for single use only.
Pack size:
Human Varicella-Zoster Immunoglobulin 100 IU/ml solution for injection.
1 × 250 mg vial.
Bio Products Laboratory Ltd., Elstree, WD6 3BX, United Kingdom
PL 08801/0013
Date of first authorisation: November 1991
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