Section 4.4 - Deleted "Thiomersal (an organomercuric compound) has been used in the manufacturing process of this medicinal product and residues of it are present in the final product. Therefore, sensitisation reactions may occur."
Section 4.8 - Added "
The current formulation of Engerix B does not contain thiomersal (an organomercuric compound).
n one clinical study conducted in adults, the incidence of pain, redness, swelling, fatigue, gastroenteritis, headache and fever was comparable to the incidence observed with former thiomersal containing vaccine formulation.
In one clinical study conducted in children, the incidence of pain, redness, swelling, drowsiness, irritability, loss of appetite and fever was comparable to the incidence observed with the former thiomersal containing vaccine formulation.
The following undesirable events have been reported following the widespread use of
former thiomersal containing vaccine formulations. As with other hepatitis B vaccines, in many instances the causal relationship to the vaccine has not been established. "
Frequency also updated.
Section 5.1 - Added under the table "
The data in the table were generated with thiomersal containing vaccines. Two additional clinical studies conducted with the current formulation of Engerix B, which contains no thiomersal, among healthy infants and adults, elicit similar seroprotection rates as compared to former thiomersal containing formulations of Engerix B.
*Seroprotection rates obtained with the Engerix B 10mg (0, 1, 6 months schedule) in subjects from 11 years up to and including 15 years of age were respectively of 55.8% at month 2, 87.6% at month 6 and 98.2% at month 7.
** At month 7, 88.8% and 97.3% of subjects aged 11 to 15 years vaccinated with Engerix B 20 mg (0, 6 months schedule) or Engerix B 10 mg (0, 1, 6 months schedule
respectively developed anti-HBs antibody titres ³ 100mIU/ml. Geometric Mean Titres were 2739 mIU/ml and 7238 mIU/ml respectively."
Section 10 - Date revised to "1 March 2007"
