Varicella-Zoster immunoglobulin human 250mg solution for injection vials

国家: 英国

语言: 英文

来源: MHRA (Medicines & Healthcare Products Regulatory Agency)

有效成分:

Varicella-Zoster immunoglobulin human

可用日期:

Bio Products Laboratory Ltd

ATC代码:

J06BB03

INN（国际名称）:

Varicella-Zoster immunoglobulin human

剂量:

250mg

药物剂型:

Solution for injection

给药途径:

Subcutaneous; Intramuscular

类:

No Controlled Drug Status

处方类型:

Valid as a prescribable product

產品總結:

BNF: 14050200; GTIN: 5019943000348

资料单张

MyGPS Europe Limited
Tel: [phone]
Job No: 1905
Project Name:
Human Varicella Zoster PIL UK
Contact:
Laura Ambrose
Client Order No.
P13280
Date:
10/12/2014
Proof No.
3
Operator:
Hema Joshi
Doc. Size:
90 x 290mm
PATIENT INFORMATION LEAFLET
HUMAN VARICELLA-ZOSTER
IMMUNOGLOBULIN 250MG
SOLUTION FOR INJECTION
SZDNL3
PLEASE READ ALL OF THIS LEAFL ET CAREFULLY BEFORE USING THIS MEDICINE.
• Keep this leafl et. You may need to read it again.
• If you have any further questions, please ask your doctor.
• This medicine has been prescribed for you personally. Do not pass
it on to
others. It may harm them, even if their symptoms are the same as
yours.
• If any of the side effects get serious, or if you notice any side
effects not listed
in this leafl et, please tell your doctor.
Is this leafl et hard to see or read? Phone [phone].
IN THIS LEAFL ET:
1. What Human Varicella-Zoster Immunoglobulin is and what it is used
for
2. Before you use Human Varicella-Zoster Immunoglobulin
3. How to use Human Varicella-Zoster Immunoglobulin
4. Possible side effects
5. How to store Human Varicella-Zoster Immunoglobulin
6. Further information
1. WHAT HUMAN VARICELLA-ZOSTER
IMMUNOGLOBULIN IS AND WHAT IT IS USED FOR
Varicella-zoster is a virus which causes chicken pox (varicella) and
shingles.
This product is a solution containing a large quantity of
varicella-zoster
immunoglobulin (antibodies) which the body produces to provide
protection
against infection with this virus. It is prepared from blood plasma
from
screened donors and virally-inactivated during manufacture.
It is used to protect against infection by the varicella-zoster virus
(VZV). Your
doctor will explain further why this medicine has been given to you.
This product is usually given to:
• newborn babies whose mothers develop chickenpox (varicella) within
7 days
before and 7 days after baby’s birth
It is also given to the following individuals who have come into
contact with a
person who has chickenpox or shingles:
• pregnant women with no antibod

产品特点

OBJECT 1
HUMAN VARICELLA-ZOSTER IMMUNOGLOBULIN
Summary of Product Characteristics Updated 05-Oct-2016 | Bio Products
Laboratory Limited
1. Name of the medicinal product
Human Varicella-Zoster Immunoglobulin 250mg solution for injection
2. Qualitative and quantitative composition
Human Varicella-Zoster Immunoglobulin Ph.Eur. contains human protein,
40-180 g/L of which at least
95% is IgG. The concentration of specific IgG to Varicella Zoster is
at least 100 IU/mL in nominal 250
mg vials. The correct volume to give 250mg 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.
3. Pharmaceutical form
Solution for injection.
4. Clinical particulars
4.1 Therapeutic indications
Prophylaxis against varicella zoster virus (VZV) infection in at risk
patients exposed to varicella
(chickenpox) or herpes zoster:
1. pregnant women with negative VZV immune status especially up to
early in the third trimester
2. neonates whose mothers develop varicella infection within 7 days
before and 7 days after delivery
3. neonates whose mothers have no history of varicella and/or a
negative immune status
4. premature infants <28 weeks of gestation or newborns with low birth
weight
5. adults and children with no history of varicella and/or a negative
immune status, receiving
immunosuppressive therapy including steroids, cytostatic agents,
radiotherapy, recent stem cell
transplantation, or who have congenital or acquired immunodeficiency
disorders and are not receiving
replacement therapy with immunoglobulin.
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
re