Rotarix Oral Vaccine

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Live attenuated human rotavirus 1e+006 CCID50 ((RIX 4414 strain))

Available from:

GlaxoSmithKline NZ Limited

INN (International Name):

Live attenuated human rotavirus 1e+006 CCID50 ((RIX 4414 strain))

Dosage:

1e+006 CCID50

Pharmaceutical form:

Oral suspension

Composition:

Active: Live attenuated human rotavirus 1e+006 CCID50 ((RIX 4414 strain)) Excipient: Di-sodium adipate Dulbecco's Modified Eagle Medium Sucrose Water for injection

Units in package:

Syringe, glass, Type 1, rubber plunger; 1.5 mL, 1 dose unit

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

GlaxoSmithKline Biologicals SA

Therapeutic indications:

ROTARIX is indicated for the prevention of rotavirus gastroenteritis

Product summary:

Package - Contents - Shelf Life: Syringe, glass, Type 1, rubber plunger; 1.5 mL - 1 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Syringe, glass, Type 1, rubber plunger; 1.5mL - 10 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Tube, LDPE with nozzle and PE cap, 3 mL - 1 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Tube, LDPE with nozzle and PE cap, 3 mL - 10 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)

Authorization date:

2007-11-14

Patient Information leaflet

1
ROTARIX
_Human Rotavirus (live attenuated oral vaccine) oral liquid _
CONSUMER MEDICINE INFORMATION LEAFLET
WHAT IS IN THIS LEAFLET?
Please read this leaflet carefully
before your child receives
ROTARIX vaccine.
This leaflet answers some
common questions about
ROTARIX. It does not contain all of
the available information.
It does not take the place of talking
to your doctor or pharmacist.
All medicines and vaccines have
risks and benefits. Your doctor has
weighed the expected benefits of
your child having ROTARIX
against the possible risks.
IF YOU HAVE ANY CONCERNS ABOUT
YOUR CHILD HAVING THIS VACCINE,
ASK YOUR DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
VACCINE.
You may need to read it again.
WHAT IS ROTARIX USED
FOR?
ROTARIX is a viral vaccine that
helps to protect your child against
gastro-enteritis (diarrhoea and
vomiting) caused by rotavirus
infection.
Rotavirus infection is the most
common cause of severe
diarrhoea in infants and young
children. Rotavirus is easily spread
by hand-to-mouth contact with
stool from an infected person.
Most children with rotavirus
diarrhoea recover on their own.
Some children become very ill
with severe vomiting, diarrhoea
and life-threatening loss of fluids
that requires hospitalisation.
Rotavirus infections are
responsible for hundreds of
thousands of deaths worldwide
every year especially in developing
countries, where nutrition and
health care are not optimal.
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 may
help 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 disease it is intended to
prevent. The vaccine will not
protect against gastro-enteritis
caused by other types of viruses or
organisms.
ROTARIX is not addictive.
BEFORE HAVING
ROTARIX
_ _
_ROTARIX SHOULD NOT BE _
_GIVEN IF: _
•
YOUR CHILD HAS PREVIOUSLY HAD
AN ALLERGI

Summary of Product characteristics

1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
_ROTARIX _Human rotavirus (live attenuated oral vaccine) oral liquid
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ROTARIX_ is a liquid suspension of the live attenuated RIX4414 strain
of human rotavirus of the G1P[8]
type for use in the prevention of rotavirus gastro-enteritis. The
virus strain derived from the 89-12 strain
is obtained by propagation on a well-characterised Vero cell line.
Each 1.5 mL dose of the vaccine contains not less than 10
6.0
CCID
50
(cell culture infectious dose 50%)
of the RIX 4414 strain of human rotavirus.
The manufacture of this product includes exposure to bovine derived
materials at the very early steps
of the production process. No bovine materials are used in routine
production. No evidence exists that
any case of vCJD (considered to be the human form of bovine spongiform
encephalopathy) has resulted
from the administration of any vaccine product.
Excipient with known effect: The vaccine also contains sucrose.
For the full list of excipients, see section 6.1 List of excipients
3.
PHARMACEUTICAL FORM
_ROTARIX _ (oral liquid) is presented as a clear, colourless liquid,
free of visible particles, for ORAL
administration only.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Rotavirus is likely to affect all children up to the age of five years
of age. The peak incidence of rotavirus
gastro-enteritis is between 6-24 months of age. Dehydration from
rotavirus gastro-enteritis can lead to
hospitalisation, which is most common in children under 2 years of
age.
_ROTARIX_ is indicated for the prevention of rotavirus gastroenteritis
(see section 5.1 Pharmacodynamic
properties).
2
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSE
The vaccination course consists of two doses. The first dose should be
given between 6 and 14 weeks
of age. The interval between the two doses should not be less than 4
weeks. The vaccine course should
be completed by the age of 24 weeks as safety has not been assessed in
older children.
In clinical trials, spitting or regurgitat