ROTARIX human rotavirus (live attenuated oral vaccine) oral liquid

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Rotavirus, Quantity: 1000000 CCID50/dose

Available from:

GlaxoSmithKline Australia Pty Ltd

INN (International Name):

Rotavirus

Pharmaceutical form:

Oral Liquid, suspension

Composition:

Excipient Ingredients: sucrose; water for injections; adipic acid; sodium hydroxide; glucose monohydrate; sodium chloride; potassium chloride; magnesium sulfate heptahydrate; ferric nitrate nonahydrate; dibasic sodium phosphate dihydrate; sodium pyruvate; folic acid; calcium pantothenate; inositol; choline chloride; nicotinamide; pyridoxine hydrochloride; thiamine hydrochloride; riboflavine; cystine; tyrosine; arginine; glycine; histidine; isoleucine; leucine; lysine; methionine; phenylalanine; threonine; tryptophan; serine; valine; glutamine; calcium chloride dihydrate; sodium bicarbonate

Administration route:

Oral

Units in package:

10, 1

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

ROTARIX is indicated for the prevention of rotavirus gastroenteritis. See Section 5.1 PHARMACODYNAMIC PROPERTIES - Clinical Trials.

Product summary:

Visual Identification: Clear, colourless liquid, free of visible particles; Container Type: Syringe; Container Material: Glass; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2008-08-27

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
AUSTRALIAN PRODUCT INFORMATION
ROTARIX HUMAN ROTAVIRUS (LIVE ATTENUATED ORAL VACCINE)
ORAL LIQUID
1
NAME OF THE MEDICINE
Human Rotavirus (live attenuated oral vaccine)
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 106.0 CCID50
(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.
Porcine Circovirus type 1 (PCV-1) material has been detected in
ROTARIX vaccine. PCV-1 is
not known to cause disease in animals and is not known to infect or
cause disease in humans.
There is no evidence that the presence of PCV-1 poses a safety risk.
The vaccine also contains sucrose. For the full list of excipients,
see Section 6.1 LIST OF
EXCIPIENTS.
3
PHARMACEUTICAL FORM
ROTARIX_ _ is presented as a clear, colourless liquid, free of visible
particles, for ORAL
administration only.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ROTARIX is indicated for the prevention of rotavirus gastroenteritis.
See Section 5.1
PHARMACODYNAMIC PROPERTIES - Clinical Trials._ _
4.2
DOSE AND METHOD OF ADMINISTRATION
_DOSAGE _
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.
2
In clinical trials, spitting or regurgitati