VARITECT 5g/1250IU/50 ml %v/v Solution for Injection

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

HUMAN PLASMA PROTEIN >95% IMMUNOGLOBULINS IMMUNOGLOBULIN VARICELLA-ZOSTER

Beschikbaar vanaf:

Biotest Pharma GmbH

INN (Algemene Internationale Benaming):

HUMAN PLASMA PROTEIN >95% IMMUNOGLOBULINS IMMUNOGLOBULIN VARICELLA-ZOSTER

Dosering:

5g/1250IU/50 ml %v/v

farmaceutische vorm:

Solution for Injection

Autorisatie-status:

Withdrawn

Autorisatie datum:

2008-08-30

Productkenmerken

PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Varitect 25 IU/ml.
Solution for Infusion.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Human varicella zoster immunoglobulin
1ml solution contains:
1gG subclass distribution:
1gG1
approx.
62.0%
1gG2
approx.
34.0%
1gG3
approx.
0.5%
1gG4
approx.
3.5%
1gA content =5mg
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Indications for use
1.
Prevention of varicella (chicken pox) for:
(a)
Children with leukaemia, lymphoma, an immune deficiency or under treatment which weakens the immune
response (immunosuppression, long-term treatment with adrenocortical hormones, radiotherapy).
(b)
Neonates whose mothers contracted chicken pox within 5 days before the birth or shortly afterwards. Time of
application: immediately after birth or when the first symptoms appear in the mother.
(c)
Children suffering from other infectious disease during suspected infection with chicken pox.
(d)
Pregnant women after suspected infection with the pathogens of chicken pox/zoster, who have not had chicken
pox.
2.
Treatment of zoster infections in high-risk patients, such as after radiation exposure or treatment with
adrenocortical hormones or cytostatic drugs etc.
Active substance(s):
Human plasma protein
100
mg
Thereof immunoglobulin
=95 %
With antibodies to varicella zoster virus
25
I.U.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 30/01/2008_
_CRN 2045961_
_page number: 1_
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Prevention of chicken pox: 0.2ml – 1 ml ( 5 - 25 I.U.) per kg body weight. In repeated exposure, e.g. household
contact, higher doses are preferable. For post-exposure prophylaxis, Varitect s