M-M-RVaxPro
Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
Uputa o lijeku
(PIL)
14-07-2022
Svojstava lijeka
(SPC)
14-07-2022
Izvješće o ocjeni javnog
(PAR)
29-05-2017
Aktivni sastojci:
measles virus Enders’ Edmonston strain (live, attenuated), mumps virus Jeryl Lynn (level B) strain (live, attenuated), rubella virus Wistar RA 27/3 strain (live, attenuated)
Dostupno od:
Merck Sharp & Dohme B.V.
ATC koda:
J07BD52
INN (International ime):
measles, mumps and rubella vaccine (live)
Terapijska grupa:
Vaccines
Područje terapije:
Rubella; Mumps; Immunization; Measles
Terapijske indikacije:
M-M-RVaxPro is indicated for simultaneous vaccination against measles, mumps, and rubella in individuals 12 months or older. For use in measles outbreaks, or for post-exposure vaccination, or for use in previously unvaccinated children older than 12 months who are in contact with susceptible pregnant women, and persons likely to be susceptible to mumps and rubella.,
Proizvod sažetak:
Revision: 30
Status autorizacije:
Authorised
Datum autorizacije:
2006-05-05
Uputa o lijeku
34
B. PACKAG
E LEAFLET
35
PACKAGE LEAFLET: INFORMATION FOR THE USER
M-M-RVAXPRO
POWDER AND SOLVENT FOR SUSPEN
SION FOR INJECTION
Measles,
mumps and rub
ella vaccine (live)
READ ALL OF THIS LEAFLET CAREFULLY
BEFORE YOU OR YOUR CHIL
D
IS VACCINATED BECAUSE IT CONTAINS
IMPORTANT IN
FORMATION FOR YOU
.
-
Keep this leaflet. You may need
to
read it again.
-
If you have any fur
ther questions, ask your doc
tor or your p
harmacist.
-
If you get any of the side effects, talk to your doctor or pharmacist.
This includes any pos
sible
side effects not l
isted in this leaflet.
See section 4.
WHAT IS IN THIS LEAFLET
1. What M-M-RvaxPro is and what it is used for
2.
What you need t
o know before you receive M
-M-RvaxPro
3. How to use M-M-RvaxPro
4. Possible sid
e effects
5. How to store
M-M-RvaxPro
6. Contents
of the pack and other i
nformation
1.
WHAT M-M-RVAXPRO
IS AND WHAT IT IS USED FOR
M-M-RvaxPro is a vaccine co
ntaining measle
s, mumps
and rubella viruses th
at have been weakened.
When a person is given t
he
vaccine, the immune sy
stem (the body's natural defences
) will make
antibodies against the measl
es, mumps
and rubella viruses. The an
tibodi
es help prot
ect against
infections
caused by these viruses.
M-M-RvaxPro is given to help protect yo
u or your chil
d a
gainst measles, mumps
and rubella. The
vaccine m
ay be admi
nistered to persons 12
months of age or older.
M-M-RvaxPro
can be administ
ere
d to infants fro
m 9 to 12
months of ag
e under special circumstances.
M-M-RvaxPro can also b
e used in measles outbre
aks, or for post-exposure vaccination, or for use in
previously unvaccinated persons older than 9
months who are in contact with suscept
ible pregnant
women, and per
sons likely t
o be susceptible to mumps and ru
bella.
Although M-M-RvaxPro
contains live viru
ses
, they are too weak to
cause measles, mumps, or rubella
in healthy people.
2.
WHAT YOU NEED T
O KNOW BEFORE YOU RECEIVE M
-M-RVAXPRO
DO NOT USE M-M-RVAXPRO
-
if t
he person to
be vaccinated
is allergic to any measles, mumps or rube
lla vaccine or
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Svojstava lijeka
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
M-M-RvaxPro
powder and solvent for suspension for injection
M-M-RvaxPro
powder and solvent for suspension for i
nje
ction in pre
-filled syringe
Measles, mumps
and rubella vaccine (live)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Af
ter reconstitution, one dose (0.5
mL) contains:
Measles virus
1
Enders’ Edmonston
strain
(live, attenuated)
………..….not less than 1x10
3
TCID
50
*
Mumps virus
1
Jer
yl Lynn™
[Level B] strain
(live, attenuated)……...…not less than 12.5x10
3
TCID
50
*
Rubella virus
2
W
istar RA 27/3 strain (live, attenuated) …………….….not less
than 1x10
3
TCID
50
*
*50% tissue
culture infectious dose
1
produced in chick emb
ryo cells.
2
produced in WI-38 human di
ploid lung fibroblasts.
The vaccine may contain traces of recombinant human albu
min (rHA).
This vaccine contains a trace amount of neomycin.
See section 4.3.
Excipient(s)
with known effect
The vaccine contains 14.5
milligrams
of sorbitol per dose. See section 4.4.
For the
full list of excipients, see section
6.1.
3.
PHARMACEUTICAL FORM
Powder and
s
olvent for suspension for injection.
Before reconstitution,
the powder is a light yellow compact crystalline cake a
nd the solvent is a cl
ear
colourless liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
M-M-RvaxPro
is indicated for simultaneou
s
vaccination against measles, mumps
and rubella in
individ
uals from 12
months of age (see section
4.2).
M-M-RvaxPro can be admini
stered to infants f
rom 9
months of age under special circumstances (see
sections
4.2, 4.4 and 5.1).
For use in measles outb
r
eaks, or for post
-
exposure vaccination, or, for use in prev
iously unvaccinated
individuals older than 9
months who are in contact
with susceptible pr
egnan
t women, and persons
likely to be susceptible to mumps and rubella, see section
5.1.
M-M-RvaxPro is t
o be used on the basis of official recommendations.
3
4.2
PO
SOLOGY AND METHOD OF ADMINISTRATION
Posology
Individuals 12 months
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