ProQuad

Riik: Euroopa Liit

keel: inglise

Allikas: EMA (European Medicines Agency)

Toimeaine:

virus, live attenuated, measles, virus, live attenuated, mumps, virus, live attenuated, rubella, virus, live attenuated, varicella

Saadav alates:

Merck Sharp & Dohme B.V.

ATC kood:

J07BD54

INN (Rahvusvaheline Nimetus):

measles, mumps, rubella and varicella vaccine (live)

Terapeutiline rühm:

Vaccines

Terapeutiline ala:

Chickenpox; Rubella; Measles; Mumps; Immunization

Näidustused:

ProQuad is indicated for simultaneous vaccination against measles, mumps, rubella and varicella in individuals from 12 months of age. ProQuad can be administered to individuals from 9 months of age under special circumstances (e.g., to conform with national vaccination schedules, outbreak situations, or travel to a region with high prevalence of measles.,

Toote kokkuvõte:

Revision: 31

Volitamisolek:

Authorised

Loa andmise kuupäev:

2006-04-05

Infovoldik

38
B. PACKAGE LEAFLET
39
PACKAGE LE
AFLET: INFORMATION FOR THE USER
PROQUAD
POWDER AND SO
LVENT FOR SUSPENSION FOR INJECTION
Measles, mumps, rubella and varicella vac
cine (live)
R
EAD ALL OF THIS LEAFLE
T CAREFULLY BEFORE YOU OR YO
UR CHILD IS VACCINA
TED
BECAUSE IT CONTAINS
IMPORTANT INFORMATI
ON FOR YOU.
-
Keep this leaflet. You may ne
ed to read it again.
-
If you have any further questions, ask your doctor or your pharm
acist.
-
This
vaccine has been presc
ribed for you o
r your child
only. Do not pass i
t on to others.
-
If you get any of the sid
e effects, talk to your doctor or pharmacis
t. This inc
ludes any possible
side effects not listed in this leaflet.
See section 4.
WHAT IS IN THIS LEAFLET
1.
What Pro
Quad is and wha
t it is used for
2.
What you need
to know before you receive ProQuad
3.
How
to use ProQuad
4.
Possible side effects
5.
How to store ProQuad
6.
Contents of the pack and other information
1.
WHAT PROQUAD I
S AND WHAT IT IS USED FOR
ProQuad
is a vaccine co
ntaining meas
les, mumps, rubella,
and chickenpox (varicella) viruses that
h
ave been weakened. When
a person is
given the vaccine, the immune system (the body’s natural
defences
) will make antibodies agains
t the measles,
mumps, rubella, and
varicella viruses. The
antibo
dies help protect against diseases caused by these viruses.
P
roQuad is given to help
protect you
r child against measles, mumps, rubella
, and chickenpox
(varicella)
. The vaccine may be adminis
tered to perso
ns from 12 months of
age.
ProQuad ma
y also be adm
inistered to infants from 9 months of age under special circum
stances (to
co
nform with national vaccination schedules, outbreak situatio
ns, or travel to a
region with high
prevalence of measle
s).
Although
ProQuad contains liv
e
viruses, they a
re too weak t
o cause measles, mumps, rubella, or
chickenpox (varicella) in
healthy people.
2.
WHAT YOU NEED TO KNOW BEFORE YOU
RECEIVE PROQUAD
DO
NOT USE PROQUAD

If the person to be vaccinated is aller
gic to any varicella
vaccine or mea
sles, mumps, or rubella

Toote omadused

1
ANNEX I
SUMMARY
OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
ProQuad powder and solvent for suspension for injection
ProQuad powder and solvent for suspension for
injection in a pre-filled syringe
Measles, mump
s,
rubella and varicella vaccin
e (live).
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
After reconstitution, one dose (0.5
mL) contains:
Measles virus
1
Enders’ Edmonston strain (live, attenuated)
........ not less than 3.00 log
10
TCID
50
*
Mumps virus
1
Jeryl Lynn
™
(Le
vel B) strain (live, attenua
ted) ...
not less than 4.30 log
10
TCID
50
*
Rubella virus
2
Wistar RA 27/3 strain (live, attenuated)
...............
not less than 3.00 log
10
TCID
50
*
Varicella virus
3
Oka/Merck strain (live, attenuat
ed) ...................
not less than 3.99 log
10
PFU**
*50% tissue cultur
e infectious dose
**plaque-f
orming units
(
1
) Produced in chick embryo cells.
(
2
) Produced in human diploid lung (WI
-38) fibroblasts.
(
3
) Produced in human diploid (MRC
-5) cells.
The vaccine may contain
traces of recombinant human alb
umin (rHA).
This vacc
ine contains a trace amount
of neomycin. See section 4.3.
Excipient(s)
with known effect
The vaccine contains 16
milligrams
of sorbitol per dose.
See section 4.4.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solve
nt for suspension for injection
Before r
econstitution, the pow
der is a white to pale yellow
compact
crystalline cake and the solvent is
a clear colourless liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ProQuad is indicated for simultaneous
vaccination against measles, mumps, rub
ella and varicella in
individuals from 12
months of age.
ProQuad
can be administered to individuals from 9
months of
age under special circumstances (e.g.,
to conform with national vaccination sche
dules, outbreak
situations, or travel to a region with hig
h
prevalence of measle
s; see sections 4.2, 4.4, and
5.1).
3
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
ProQu
ad should be used in accordance to official r