Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Bio Products Laboratory Ltd., Elstree, WD6 3BX, United Kingdom
Prophylaxis against varicella zoster virus (VZV) infection in at risk patients exposed to varicella (chickenpox) or herpes zoster:
Notes on use of Human Varicella-Zoster Immunoglobulin
Whenever possible, contacts without a definite history of chickenpox should be screened for antibody by a sensitive test (e.g. ELISA, radioimmunoassay or immunofluorescence). There is no need to test neonates for antibody.
If antibodies to VZV are detectable, Human Varicella-Zoster Immunoglobulin is generally NOT needed. The following infants will possess maternal antibody and do NOT require Human Varicella-Zoster Immunoglobulin.
≥15 IU/kg body weight as soon as possible, ideally within 3 days but within 10 days maximum.
Alternative dose levels for treatment are as follows:
0-5 years: 250 mg (1 vial)
6-10 years: 500 mg (2 vials)
11-14 years: 750 mg (3 vials)
15 years and older: 1000 mg (4 vials)
If a second exposure to chickenpox occurs three weeks or more after the first dose of Human Varicella-Zoster Immunoglobulin, a second dose is required.
Human Varicella-Zoster Immunoglobulin should be administered via the intramuscular route. If a large volume (>2 ml for children or >5 ml for adults) is required, it is recommended to administer this in divided doses at different sites.
If intramuscular administration is contraindicated (bleeding disorders), the injection can be administered subcutaneously. However, it should be noted that there are no clinical efficacy data to support administration by the subcutaneous route.
The safety and efficacy of Human Varicella-Zoster Immunoglobulin in children aged 0-18 years has not been established. No data are available.
Consequences of an overdose are not known.
Shelf life: 3 years.
Once the vial has been opened, the solution should be used immediately.
Store in a refrigerator (2°C-8°C).
Do not freeze.
Keep vial in the outer carton in order to protect from light.
Storage for up to one week at 25°C in the original container is not detrimental.
For storage conditions after first opening of the medicinal product, see section 6.3.
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.
The product should be brought to room or body temperature before use.
Do not use solutions which are cloudy or have deposits.
Any used product or waste material should be disposed of in accordance with local requirements.
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