Rotarix

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

human rotavirus, live attenuated

Saatavilla:

GlaxoSmithKline Biologicals S.A.

ATC-koodi:

J07BH01

INN (Kansainvälinen yleisnimi):

rotavirus vaccine, live

Terapeuttinen ryhmä:

Vaccines

Terapeuttinen alue:

Immunization; Rotavirus Infections

Käyttöaiheet:

Rotarix is indicated for the active immunisation of infants aged 6 to 24 weeks for prevention of gastroenteritis due to rotavirus infection.The use of Rotarix should be based on official recommendation.

Tuoteyhteenveto:

Revision: 41

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2006-02-21

Pakkausseloste

56
B. PACKAGE LEAFLET
57
PACKAGE LEAFLET: INFORMATION FOR THE USER
ROTARIX POWDER AND SOLVENT FOR ORAL SUSPENSION
rotavirus vaccine, live
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOUR CHILD RECEIVES THIS
VACCINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This vaccine has been prescribed for your child only. Do not pass it
on to others.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Rotarix is and what it is used for
2.
What you need to know before your child receives Rotarix
3.
How Rotarix is given
4.
Possible side effects
5.
How to store Rotarix
6.
Contents of the pack and other information
1.
WHAT ROTARIX IS AND WHAT IT IS USED FOR
Rotarix is a viral vaccine, containing live, attenuated human
rotavirus, that helps to protect your child,
from the age of 6 weeks, against gastro-enteritis (diarrhoea and
vomiting) caused by rotavirus
infection.
HOW ROTARIX WORKS
Rotavirus infection is the most common cause of severe diarrhoea in
infants and young children.
Rotavirus is easily spread from hand-to-mouth due to contact with
stools from an infected person.
Most children with rotavirus diarrhoea recover on their own. However,
some children become very ill
with severe vomiting, diarrhoea and life-threatening loss of fluids
that requires hospitalisation.
When a person is given the vaccine, the immune system (the body’s
natural defences) will make
antibodies against the most commonly occurring types of rotavirus.
These antibodies protect against
disease caused by these types of rotavirus.
As with all vaccines, Rotarix may not completely protect all people
who are vaccinated against the
rotavirus infections it is intended to prevent.
2.
WHAT YOU NEED TO KNOW BEFORE YOUR CHILD RECEIVES ROTARIX
ROTARIX SHOULD NOT BE GIVEN
•
if your child has previously had any a

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Rotarix powder and solvent for
ORAL
suspension
Rotavirus vaccine, live
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
After reconstitution, 1 dose (1 mL) contains:
Human rotavirus RIX4414 strain (live, attenuated)*
not less than 10
6.0
CCID
50
*Produced on Vero cells
Excipients with known effect:
This product contains 13.5 mg of sorbitol, 9 mg of sucrose, 10
micrograms of glucose and
0.15 microgram of phenylalanine per dose (see section 4.4).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for
ORAL
suspension.
The powder is white.
The solvent is a turbid liquid with a slow settling white deposit and
a colourless supernatant.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rotarix is indicated for the active immunisation of infants aged 6 to
24 weeks for prevention of gastro-
enteritis due to rotavirus infection (see sections 4.2, 4.4 and 5.1).
The use of Rotarix should be based on official recommendations.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
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.
Rotarix may be given with the same posology to preterm infants born
after at least 27 weeks of
gestational age (see sections 4.8 and 5.1).
In clinical trials, spitting or regurgitation of the vaccine has
rarely been observed and, under such
circumstances, a replacement dose was not given. However, in the
unlikely event that an infant spits
out or regurgitates most of the vaccine dose, a single replacement
dose may be given at the same
vaccination visit.
It is recommended that infants who receive a first dose of Rotarix
complete the 2-dose regimen with
Rotarix. There are no data on safety, immunogenicity or efficacy when
Rotarix is administered for the
fir