RotaTeq
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
04-04-2023
Valmisteyhteenveto
(SPC)
04-04-2023
Julkisesta arviointikertomuksesta
(PAR)
01-03-2016
Aktiivinen ainesosa:
rotavirus serotype G1, serotype G2, serotype G3, serotype G4, serotype P1
Saatavilla:
Merck Sharp & Dohme B.V.
ATC-koodi:
J07BH02
INN (Kansainvälinen yleisnimi):
rotavirus vaccine, live
Terapeuttinen ryhmä:
Vaccines, Viral vaccines
Terapeuttinen alue:
Immunization; Rotavirus Infections
Käyttöaiheet:
RotaTeq is indicated for the active immunisation of infants from the age of six weeks to 32 weeks for prevention of gastroenteritis due to rotavirus infection.RotaTeq is to be used on the basis of official recommendations.
Tuoteyhteenveto:
Revision: 36
Valtuutuksen tilan:
Authorised
Valtuutus päivämäärä:
2006-06-26
Pakkausseloste
22
B. PACKAGE LEAFLET
23
PACKAG
E LEAFLET: INFORMATION FOR THE U
SER
ROTATEQ ORAL SOLUTIO
N
Rotavirus vaccine (live)
READ ALL OF THIS LEAFLET CAREFULLY
BEFORE YOUR CHILD IS VACCINATED
BECAUSE IT CONTA
INS IMPORTANT
INFORMATION FOR Y
OU.
-
Keep this leafl
et. Yo
u may need to read it again.
-
If you have any further questions, ask your doctor
or pharmacist.
-
If your child gets any side effects, talk to your d
octor or pharmacist.
This includes any possible
side e
ffects not listed in this leafl
et.
See section 4.
WHAT IS I
N THIS LEAFLET
1.
What RotaTeq is and what it is used for
2.
What you need to know
before your
child receive
s RotaTeq
3.
How to use RotaTeq
4.
Possible side effects
5.
How to store RotaTeq
6.
C
ontents of the pack and other
information
1.
WHAT ROTAT
EQ IS AND WHAT IT IS USED FOR
RotaTeq is an oral vaccine that helps protect infants an
d young chil
dren against g
astroenteritis
(diarrhoea and vom
iting) caused by rotavirus infection
and may be given
to infants from the age of
6 weeks to 32 weeks (see section 3).
The vaccine contains five types of live rotavirus strains.
When
an
infant is given the va
ccine, the immun
e system (the body
’s natural d
efe
nces) will make antibodies
against the most commonl
y occurring types of rotavirus. Th
ese antibodies h
elp protect against
gastroenteritis caused by these types of rotavirus.
2.
WHAT YOU NEED TO
KNOW BEFORE YOUR CHILD RECEIVES ROTATEQ
DO NO
T USE ROTATE
Q IF
-
your child is allergic to any of the components
of this
vaccine (see section
6 Con
tents of the
pack and oth
er information
).
-
your child developed an allergic reaction after receiving a dose of
RotaTeq or
other rotavirus
vaccine.
-
your chil
d has previou
sly
had intussusception (a bowel obstruction in whic
h one segment of
bowel becomes enfol
ded within anot
her segmen
t).
-
your child was born with a malformation of the gastrointestinal system
that migh
t predispose for
intussuscept
ion.
-
your child h
as any diseas
e w
hich reduces his/her resistance to infection.
-
you
r child has
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Valmisteyhteenveto
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
RotaTeq
ORAL
solution
Rotavirus vaccine
(live)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose (2
ml) contains:
rotavirus type* G1
not less than 2.2 x 10
6
IU
1, 2
rotavirus type* G2
not less than 2.8 x 10
6
IU
1, 2
rotavirus type* G3
not less than 2.2 x 10
6
IU
1, 2
rotavirus type* G4
not less than 2.0 x 10
6
IU
1, 2
rotavirus type* P1A[8]
not less than 2.3 x 10
6
IU
1, 2
* human-
bovine rotavirus reass
or
tants (live), produced in Vero cells.
1
Infectious Units
2
As lower confidence limit (p = 0.95)
Excipients
with known effect
This vaccine contain
s 1080
milligrams
sucrose and 37.6 milligrams sodium (see section 4.4).
For the
full list of excipien
ts, see section 6.1.
3.
PHARMACEUTICAL F
ORM
Oral Solution
Pale yellow clear liquid that may have a pink tint
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
RotaTeq is indicated for the active immunisation of infants from the
age of 6
weeks to 32 weeks for
prevention of gastroenteritis
due to rotavirus infection (see sections
4.2, 4.4 and 5.1).
RotaTeq is to be used on the basis of official recommendations.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
FROM BIRTH TO 6 WEEKS
RotaTeq is not ind
icated in this subset of paediatri
c population.
The safety and efficacy of RotaTeq in individuals from birth to 6
weeks of age have not been
established.
FROM 6 WEEKS TO 32 WEEKS
The vaccination course consists of three doses.
The first dose m
ay be adm
inistered from the age of 6
weeks
and no later than the age of 12
weeks.
3
RotaTeq may be given to infants who were born prematurely provided
that the period of gestation was
at least 25 weeks.
These infants should receive the first dose of RotaTe
q at least
six weeks after birth
(see sections
4.4 and 5.1).
There should be intervals of at least 4
weeks between doses.
It is preferable that the vaccination course of three doses should be
comp
leted by the age of
20-22
weeks. If necessary,
the third (last) dose
may be given up to the age
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