Human immunoglobulin anti - varicella- zoster virus (25 IU/ ml)
Composition: 1 ml solution contains: protein 50 mg, of which human immunoglobulin makes up at least 95%. Antibody content against varicella-zoster virus 25 IU. Further constituents: Glycine, water for injections.

Indications:
1.Prevention of varicella (chicken-pox) for:
a) Children with leukaemia, lymphoma, an immune deficiency or under treatment which weakens the immune response (immu-nosuppression, long-term treatment with adrenocortical hormones, radiotherapy).
b) Neonates whose mothers contracted chicken pox within 5 days before birth or shortly afterwards. Time of application: immediately after birth or when the first symptoms appear in the mother.
c) Children suffering from another infectious disease during suspected infection with chicken pox.
d) Pregnant women after suspected infection with the pathogen of chicken pox/zoster, who have not yet 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.

Contra-indications: Hypersensitivity to any of the components. Hypersensitivity to homologous immunoglobulins, especially in very rare cases of IgA. Deficiency, when the patient has antibodies against IgA. Pregnancy and lactation. The safety of this medicinal product for use in human pregnancy has not been established in controlled clinical trials and therefore should only be given with caution to pregnant women and breast-feeding mothers. Long lasting clinical experience with immunoglobulins dose indicates that no harmful effects on the course of pregnancy, on the foetus and the neonate are to be expected. Immunoglobulins are excreted into the milk and may contribute to the transfer of protective antibodies to the neonate.

Special precautions for use: Certain severe adverse drug reactions may be related to the rate of infusion. The recommended infusion rate given under " Method of administration" must be closely followed and patients must be closely monitored and carefully observed for any symptoms throughout the infusion period. Patients should be observed for at least 20 minutes after administration. Effects on ability to drive and use machines: There ara no indications that Varitect^® CP may impair the ability to drive and use machines.

Dosage instructions and duration of application: Prevention of chickenpox: 1 ml (25 IU) per kg body weight. In repeated exposure, e. g. household contact, higher doses are preferable. For post- exposure prophylaxis, Varitect^® CP should be administered as soon as possible and not later than 96 h after exposure. Treatment of zoster infections; 1-2 ml (25-50 IU) per kg body weight, with additional applications depending on the course of clinical manifestations.

Interactions with other medicinal products: Immunoglobulin administration may impair for a period of at least 6 weeks and up to 3 months the efficacy of live attenuated virus vaccines such as measles, rubella, mumps, and varicella. After injection of immunoglobulins the transitory rise of the various passively transferred antibodies in the patient's blood may result in misleading positive results in serological testing.

Method of administration: Varitect^® CP is intended for intravenous use .During the infusion, the rate of 20 drops per minute (corresponding to 1ml per minute) must not be exceeded. Varitect^® CP should be inspected visually for particulate matter and discoloration prior to administration. Do not use solutions which are cloudy or which have deposits. Varitect^® CP should be brought to room or body temperature before administration.

Special precautions for storage: The shelf-life is 3 years. Varitect^® CP should not be used after the expiry date indicated on the label. Varitect^® CP has to be stored at +2 °C To 8 °C , protected from light. Do not freeze. The solution should be administered immediately after opening the receptacle. Any unused solution must be discarded because of bacterial contamination risk.

Presentations: Varitect^® CP is a ready for-use solution for intravenous administration provided in glass containers: Vial with 5 ml (125 IU), vial with 20 ml (500 IU), vial with 50 ml (l,250 IU).

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