| Section 1
Letter a inserted before “prefilled syringe”
(Inactivated) replaced by (whole virus, Inactivated)
Section 3
"Opaque" replaced by "opalescent"
Section 4.3 Contraindications
"Component,one" replaced by "substance,any"
Section 4.8
Paragraph inserted following 3rd paragraph after “15 yr old children”
“In an active postmarketing surveillance in children aged 1 to 12 years the reported fever rates (fever measured rectally) after the first vaccination were 23.7% in 1 to 3 year olds (n=1198) and 13.7% in 4 to 12 year olds (n=234)”
Undesirable effects
Very common: "> 10%" replaced by "> 1/10"
Common: "> 1% and <10%" replaced by "> 1/100 to <1/10"
Uncommon: "> 0.1% and <1%" replaced by "> 1/1,000 to <1/100"
Rare: > 1/10,000 to <1/1,000 -added
Very rare: "<0.01%" replaced by "<1/10,000"
Not known: Cannot be estimated from the available data -added
Undesirable effects listed on old SPC have been changed into table form. See page 5 section 4.8.
*Undesirable effects under this frequency category are derived from a spontaneous reporting systemand thus,there is no valid estimate of incidence rates
Section 4.9
1st sentence : “There is no experience of overdose” reworded to say “ No case of overdose has been reported”
Section 5.1
Addition to 3rd paragraph
“Based on a follow up surveillance performed among the total Austrian population for the years 2000 to 2006, a protection rate of 99 % was calculated with no statistically significant difference between age groups in regularly vaccinated persons. The protection rate is at least as high after the first two vaccinations, following the regular vaccination i.e before completion of the basic vaccination scheme by the third vaccination, but it is significantly lower in those with a record of irregular vaccination.”
Section 5.3
“Animal studies performed have shown no indication of a safety risk for humans” changed to “Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology.”
Section 6.1
List of excipients
Human albumin sodium chloride, disodium phosphate-dihydrate, potassium
dihydrogenphosphate, water for injection injection as well as aluminium hydroxide, hydrated
(see Section 2). The levels of potassium and sodium are at less than 1 mmol per dose, i.e.
essentially “potassium- and sodium-free”.
Changed to:
Human albumin
Sodium chloride
Disodium phosphate-dihydrate
Potassium dihydrogenphosphate
Water for injections
Sucrose
Aluminium hydroxide, hydrated.
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