Rotarix suspension oral

Kraj: Armenia

Język: angielski

Źródło: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Składnik aktywny:

human rotavirus vaccine live

Dostępny od:

GlaxoSmithKline Biologicals s.a.

Kod ATC:

J07BH01

INN (International Nazwa):

human rotavirus vaccine live

Dawkowanie:

not less than 10^6CCID^50/dose

Forma farmaceutyczna:

suspension oral

Sztuk w opakowaniu:

(50) plastic tube 1.5ml (1 dose)

Typ recepty:

Prescription

Status autoryzacji:

Registered

Data autoryzacji:

2022-09-23

Ulotka dla pacjenta

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ROTARIX ORAL SUSPENSION IN PLASTIC TUBE
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 allergic reaction to rotavirus

Charakterystyka produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Rotarix ORAL suspension in plastic tube
Rotavirus vaccine, live
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 dose (1.5 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 1,073 mg of sucrose, 34 mg of sodium, 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
ORAL suspension.
Rotarix is a clear and colourless liquid.
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
first dose and another rotavirus vaccine is administered for the
second dose or vice versa.
_ _
_Paediatric population _
Rotarix should not