PRIORIX

País: Australia

Idioma: inglés

Fuente: Department of Health (Therapeutic Goods Administration)

Ingredientes activos:

Measles virus, Quantity: 1000 CCID50; Rubella virus, Quantity: 1000 CCID50; Mumps virus, Quantity: 25119 CCID50; live varicella vaccine, Quantity: 1995 PFU

Disponible desde:

GlaxoSmithKline Australia Pty Ltd

Designación común internacional (DCI):

live varicella vaccine,Measles virus,Mumps virus,Rubella virus

formulario farmacéutico:

Diluent, not applicable

Composición:

Excipient Ingredients: water for injections

Vía de administración:

Intramuscular, Subcutaneous

Unidades en paquete:

1 vial of active and 1 Diluent ampoule, 10 vials of active and 10 Diluent ampoules

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

Priorix-Tetra is indicated for active immunisation against measles, mumps, rubella and varicella from 9 months of age.

Resumen del producto:

Visual Identification: ; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 18 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Estado de Autorización:

Registered

Información para el usuario

PRIORIX-TETRA
1
PRIORIX-TETRA
_Measles-Mumps-Rubella-Varicella vaccine (live, attenuated) _
CONSUMER MEDICINE INFORMATION LEAFLET
WHAT IS IN THIS
LEAFLET
This leaflet answers some of the
common questions about PRIORIX-
TETRA vaccine. It does not contain
all the available information. It does
not take the place of talking to your
doctor, nurse or pharmacist.
All medicines and vaccines have
risks and benefits. Your doctor has
weighed the possible risks of you or
your child having PRIORIX-TETRA
against the expected benefits.
IF YOU HAVE ANY CONCERNS ABOUT
PRIORIX-TETRA TALK TO YOUR
DOCTOR, NURSE OR PHARMACIST.
KEEP THIS LEAFLET WITH THIS VACCINE.
You may need to read it again.
WHAT PRIORIX-
TETRA IS USED FOR
PRIORIX-TETRA is a vaccine used
to prevent four diseases, measles,
mumps, rubella (German measles)
and varicella (chickenpox).
Measles, mumps, rubella and
varicella are all infectious diseases
caused by viruses. The vaccine
works by causing the body to
produce its own protection
(antibodies) against these diseases.
_MEASLES _
Measles is a highly infectious viral
illness. Measles is spread by small
droplets from the nose, throat or
mouth of an infected person (often
before it is obvious they have
measles). Measles often begins with
a fever, runny nose, hacking cough
and conjunctivitis (eye
inflammation). The rash appears 3-5
days after the onset of symptoms and
spreads rapidly all over the body.
Measles is often a severe disease
complicated by ear infection and
pneumonia (lung infection).
Encephalitis (swelling of the brain)
can also occur and can sometimes
result in permanent brain damage or
death.
Unimmunised children in the
following groups are at particular
risk from severe measles infection:
•
children with chronic conditions
such as cystic fibrosis, congenital
heart or kidney disease, failure to
thrive, Down's Syndrome
•
children from the age of 1 year
upwards in child care centres,
family day care and playgroups
•
children living in institutions
•
Aboriginal and Torres Strait
Islander children.
_MU

Ficha técnica

1
AUSTRALIAN PRODUCT INFORMATION
PRIORIX TETRA (MEASLES, MUMPS, RUBELLA AND VARICELLA) VACCINE,
(LIVE, ATTENUATED), POWDER AND DILUENT FOR SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
Measles virus, mumps virus, rubella virus and live varicella vaccine.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
PRIORIX-TETRA is a sterile lyophilised mixed preparation containing
the attenuated
Schwarz measles virus strain, the RIT 4385 strain of mumps virus
(derived from the Jeryl
Lynn strain), the Wistar RA 27/3 rubella virus strain and the OKA
strain of varicella-zoster
virus. Each virus strain is separately produced in either chick embryo
cells (mumps and
measles) or MRC5 human diploid cells (rubella and varicella).
Each 0.5 mL dose of the reconstituted vaccine contains not less than
10
3.0
CCID
50
(cell
culture infective dose 50%) of the Schwarz measles, not less than 10
4.4
CCID
50
of the RIT
4385 mumps, not less than 10
3.0
CCID
50
of the Wistar RA 27/3 rubella and not less than
10
3.3
plaque-forming units (PFU) of the varicella-zoster OKA virus strains.
The four virus
strains are mixed prior to lyophilisation.
The manufacture of this product includes exposure to bovine derived
materials sourced to
minimise the risk of prion contamination. 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.
PRIORIX-TETRA meets the World Health Organisation requirements for
manufacture of
biological substances and for measles, mumps, rubella and varicella
vaccines and combined
vaccines (live).
LIST OF EXCIPIENTS WITH KNOWN EFFECT
PRIORIX-TETRA also contains the excipient ingredient phenylalanine and
residual amounts
of neomycin sulphate, which is carried over from the manufacturing
process.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Powder and diluent for solution for injection.
PRIORIX-TETRA is presented as a whitish to slightly pink powder for
reconstitution with
clear and