Citiraj:
The Rotarix™ vaccine is administered orally in a 2-dose
schedule to infants of approximately 2 and 4 months of
age. The fi rst dose can already be administered at the
age of 6 weeks and should be given no later than at
the age of 12 weeks. The interval between the 2 doses
should be at least 4 weeks. The 2-dose schedule should
be completed by age 16 weeks, and no later than by
24 weeks of age.
Ovdje
Citiraj:
The vaccination course consists of two doses. The first dose may be administered from the age of 6 weeks. There should be an interval of at least 4 weeks between doses. The vaccination course should preferably be given before 16 weeks of age, but must be completed by the age of 24 weeks.
a bormeš i ovdje (EMEA: scientific discussion on Rotarix)
Citiraj:
Sporadic, naturally occurring
intussusception tends to peak in incidence between 5 to 9 months of age, and occurs only very rarely
before that age. The studies have been performed in children younger than 5 months and the data
provided by the applicant did not show evidence that intussusception is age related. Taking this into
consideration and in order to accommodate the diversity in the European vaccination schedules, it is
decided to allow more flexibility for the time point of the second dose. Thefollowing wording for
section 4.2 is decided by the CHMP: The vaccination course consists of two doses. The first dose
should be given between 6 and 14 weeks of age. “The interval between doses should be at least 4 40/40 ©EMEA 2006
weeks. The second dose should be given preferably before 16 weeks and not later than the age of 24
weeks”