HUMAN VARICELLA-ZOSTER IMMUNOGLOBULIN Solution for injection Ref.[9853] Active ingredients: Human varicela zoster immunoglobulin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Bio Products Laboratory Ltd., Elstree, WD6 3BX, United Kingdom

Product name and form

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).

Qualitative and quantitative composition

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
Glycine
Sodium acetate trihydrate

Pack sizes and marketing

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.

Marketing authorization holder

Bio Products Laboratory Ltd., Elstree, WD6 3BX, United Kingdom

Marketing authorization dates and numbers

PL 08801/0013

Date of first authorisation: November 1991

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