SII Rotavirus Vaccine Live AttenuatedOral(Freeze-Dried)

Land: Malaysia

Språk: engelska

Källa: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktiva substanser:

Live Attenuated Bovine-Human Rotavirus Reassortant [G1, G2, G3, G4 and G9]

Tillgänglig från:

SM PHARMACEUTICALS SDN. BHD.

INN (International namn):

Live Attenuated Bovine-Human Rotavirus Reassortant [G1, G2, G3, G4 and G9]

Enheter i paketet:

50x1dose Vials

Tillverkad av:

SERUM INSTITUTE OF INDIA PRIVATE LIMITED

Bipacksedel

Not applicable

Produktens egenskaper

PREGNANCY
LACTATION
Rotavirus Vaccine, Live Attenuated (Oral) is not intended for use in
adults. There are no
data of its use during pregnancy and lactation.
A total of seven cases of intussusception occurred until time of
primary analysis of
which four were in the Rotavirus Vaccine, Live Attenuated (Oral) group
and three in the
Placebo group. None of the cases occurred within 28 days of receiving
a dose of
Rotavirus Vaccine, Live Attenuated (Oral) or Placebo. All cases of
intussusception were
causally unrelated to study vaccination.
PRECLINICAL SAFETY DATA
ADVERSE REACTIONS
In the phase III trial of Rotavirus Vaccine, Live Attenuated (Oral),
no differences were
detected between Rotavirus Vaccine, Live Attenuated (Oral) and placebo
groups in the
post-vaccination rates of solicited adverse events within 7 days of
each dose of
vaccine. These events in decreasing order of frequency were : Fever
(68.2% in the
Rotavirus Vaccine, Live Attenuated (Oral) group, 69.7% in the placebo
group),
irritability (42.6% in the Rotavirus Vaccine, Live Attenuated (Oral)
group, 36.1% in the
placebo group), decreased appetite (20.4% in the Rotavirus Vaccine,
Live Attenuated
(Oral) group, 20.0% in the placebo group), decreased activity level
(18.8% in the
Rotavirus Vaccine, Live Attenuated (Oral) group, 17.1% in the placebo
group), vomiting
(17.0% in the Rotavirus Vaccine, Live Attenuated (Oral) group, 16.9%
in the placebo
group) and diarrhea (8.4% in the Rotavirus Vaccine, Live Attenuated
(Oral) group,
10% in the placebo group). Except for irritability, the incidence of
all solicited events
was similar in Rotavirus Vaccine, Live Attenuated (Oral) and placebo
groups. Most of
these events were of short duration and predominately mild (98% of
episodes) in
severity. It should be noted that in the phase 3 efficacy study,
Rotavirus Vaccine, Live
Attenuated (Oral) and placebo were administered to all children
concomitantly with
DTwP vaccine, which is known to cause a level of reactogenicity
similar to that
observed in this study.
EFFECTS ON A