Euvax-B Special Precautions

General precautions: The administration of Euvax-B should be postponed in patients suffering from acute severe febrile illness.
In patients suffering from multiple sclerosis, any stimulation of the immune system can induce exacerbation of their symptoms. Therefore, for these patients the benefits of vaccination against Hepatitis B should be weighed against risks of exacerbation of multiple sclerosis (see Adverse Reactions).
It is considered that protection cannot be obtained by vaccination in patients in latent or progressive state of Hepatitis B.
As with all injectable vaccines, appropriate medical treatment should always be readily available in case of rare anaphylactic reactions following the administration of the vaccine.
Thimerosal (an organomercuric compound) has been used in the manufacturing process of this medicinal product. Therefore, sensitization reactions may occur.
Precautions for usage: Shake before administration, since a fine white deposit with a clear colorless supernatant may form during storage.
Euvax-B should not be administered in the gluteal region and it must not be administered intravenously.
In preterm babies (<2,000 grams), it is advisable to check antibody titers one month after the third dose to assess the need for a booster dose.
Use in Pregnancy & Lactation: The effect of the HBsAg on foetal development has not been assessed. However, as with all inactivated viral vaccines, the risks to the foetus are considered to be negligible. Euvax-B should be used during pregnancy only when clearly needed.
The effect on breast-fed infants of the administration of Euvax-B to their mothers has not been evaluated in clinical studies. No contraindication has been established.