Priorix

Nchi: Nyuzilandi

Lugha: Kiingereza

Chanzo: Medsafe (Medicines Safety Authority)

Viambatanisho vya kazi:

Measles vaccine, Schwarz strain 1000 CCID50 (not less than); Mumps virus, live attenuated, RIT 4385 5012 CCID50 (not less than);  ; Rubella virus, Wistar RA27/3 strain 1000 CCID50 (not less than)

Inapatikana kutoka:

GlaxoSmithKline NZ Limited

INN (Jina la Kimataifa):

Measles vaccine, Schwarz strain 1000 CCID50 (not less than)

Kipimo:

0.5 mL

Dawa fomu:

Powder for injection with diluent

Tungo:

Active: Measles vaccine, Schwarz strain 1000 CCID50 (not less than) Mumps virus, live attenuated, RIT 4385 5012 CCID50 (not less than)   Rubella virus, Wistar RA27/3 strain 1000 CCID50 (not less than) Excipient: Amino acids Lactose Mannitol Sorbitol Water for injection

Vitengo katika mfuko:

Ampoule, glass, Single dose, diluent, 0.5 mL

Darasa:

Prescription

Dawa ya aina:

Prescription

Viwandani na:

GlaxoSmithKline Biologicals SA

Matibabu dalili:

PRIORIX is indicated for the active immunisation against measles, mumps and rubella.

Bidhaa muhtasari:

Package - Contents - Shelf Life: Ampoule, glass, Single dose, diluent - 0.5 mL - 60 months from date of manufacture stored at or below 30°C. Do not freeze - Ampoule, glass, 10x0.5mL diluent - 10 dose units - 60 months from date of manufacture stored at or below 30°C. Do not freeze - Combination pack, 1 x 0.5mL diluent syringe + 1 x vaccine dose - 1 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 8 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) - Combination pack, 10x0.5mL diluent syringe + 10 x vaccine doses - 10 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 8 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) - Syringe, glass, single dose, diluent - 0.5 mL - 60 months from date of manufacture stored at or below 30°C. Do not freeze - Vial, single dose, type I glass, vaccine - 1 dose units - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) 8 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze)

Idhini ya tarehe:

1997-08-14

Taarifa za kipeperushi

PRIORIX
1
PRIORIX
_Measles-Mumps-Rubella vaccine live _
NEW ZEALAND CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some of the
common questions about PRIORIX
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 against
the expected benefits.
IF YOU HAVE ANY CONCERNS ABOUT
PRIORIX TALK TO YOUR DOCTOR,
NURSE OR PHARMACIST.
Keep this leaflet with this vaccine.
You may need to read it again.
WHAT PRIORIX IS
USED FOR
PRIORIX is a vaccine used to
prevent three diseases, measles,
mumps and rubella (German
measles). The vaccine is sometimes
called MMR vaccine.
Measles, mumps and rubella 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
_MUMPS _
Mumps is an infectious viral disease
spread by infected droplets of saliva.
Symptoms often begin wi

Tabia za bidhaa

1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
PRIORIX powder for injection with diluent
Live trivalent attenuated measles, mumps and rubella vaccine.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
PRIORIX is a lyophilised mixed preparation of the attenuated Schwarz
measles, RIT
4385 mumps (derived from Jeryl Lynn strain) and Wistar RA 27/3 rubella
strains of
viruses, separately obtained by propagation either in chick embryo
tissue cultures
(mumps and measles) or MRC
5
human diploid cells (rubella).
PRIORIX meets the World Health Organisation requirements for
manufacture of
biological substances and for measles, mumps and rubella vaccines and
combined
vaccines (live).
Each 0.5 mL dose of the reconstituted vaccine contains not less than
10
3.0
CCID
50
of
the Schwarz measles, not less than 10
3.7
CCID
50
of the RIT 4385 mumps, and not
less than 10
3.0
CCID
50
of the Wistar RA 27/3 rubella virus strains.
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Powder for injection in a glass vial.
Diluent solution for injection in a glass pre-filled syringe or
ampoule.
PRIORIX is presented as a whitish to slightly pink powder . The
sterile diluent is
clear and colourless.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
PRIORIX is indicated for the active immunisation against measles,
mumps and
rubella from 12 months of age.
The use of Priorix should be in accordance with official
recommendations.
4.2
Dose and method of administration
Dose
A single 0.5 mL dose of the reconstituted vaccine is recommended.
2
Method of Administration
For information on instructions on preparation or reconstitution
please refer to section
6.6 Special precautions for disposal and other handling.
PRIORIX is for subcutaneous injection, although it can also be given
by
intramuscular injection, in the deltoid region or in the anterolateral
area of the thigh
(see section 4.4 Special warnings and precautions for use).
PRIORIX must not be administered intravascularly.
The vaccine should be administered subcutaneousl