M-M-RVAXPRO vaccine powder and solvent for suspension for injection 0.5ml pre-filled syringes

Land: Vereinigtes Königreich

Sprache: Englisch

Quelle: MHRA (Medicines & Healthcare Products Regulatory Agency)

Wirkstoff:

Rubella virus live attenuated; Mumps virus live attenuated; Measles virus live attenuated

Verfügbar ab:

Merck Sharp & Dohme Ltd

ATC-Code:

J07BD52

INN (Internationale Bezeichnung):

Rubella virus live attenuated; Mumps virus live attenuated; Measles virus live attenuated

Darreichungsform:

Powder and solvent for suspension for injection

Verabreichungsweg:

Intramuscular; Subcutaneous

Klasse:

No Controlled Drug Status

Verschreibungstyp:

Valid as a prescribable product

Produktbesonderheiten:

BNF: ; GTIN: 5015973773016

Gebrauchsinformation

PACKAGE LEAFLET: INFORMATION FOR THE USER
M-M-RVAXPRO®
POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE
Measles, mumps and rubella vaccine (live)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD IS
VACCINATED BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or your pharmacist.
-
If you get any of the side effects, talk to your doctor of pharmacist.
This includes any possible
side effects not listed 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 to know before you receive M-M-RVAXPRO
3. How to use M-M-RVAXPRO
4. Possible side effects
5. How to store M-M-RVAXPRO
6. Content of the pack and other information
1.
WHAT M-M-RVAXPRO IS AND WHAT IT IS USED FOR
M-M-RVAXPRO is a vaccine containing measles, mumps, and rubella
viruses that have been
weakened. When a person is given the vaccine, the immune system (the
body's natural defences) will
make antibodies against the measles, mumps, and rubella viruses. The
antibodies help protect against
infections caused by these viruses.
M-M-RVAXPRO is given to help protect you or your child against
measles, mumps, and rubella. The
vaccine may be administered to persons 12 months of age or older.
M-M-RVAXPRO
can
be
administered
to
infants
from
9
to
12
months
of
age
under
special
circumstances.
M-M-RVAXPRO can also be used in measles outbreaks, or for
post-exposure vaccination, or for use
in previously unvaccinated persons older than 9 months who are in
contact with susceptible pregnant
women, and persons likely to be susceptible to mumps and rubella.
Although M-M-RVAXPRO contains live viruses, they are too weak to cause
measles, mumps, or
rubella in healthy people.
2.
WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE M-M-RVAXPRO
DO NOT USE M-M-RVAXPRO:
-
If you or your child are allergic to any of the components of this
vaccine (including neomycin or
any of the other ingredients li

Fachinformation

OBJECT 1
MMRVAXPRO
Summary of Product Characteristics Updated 19-Jun-2017 | Merck Sharp &
Dohme Limited
1. Name of the medicinal product
M-M-RVAXPRO® powder and solvent for suspension for injection in
pre-filled syringe
Measles, mumps, and rubella vaccine (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
1x10
3
CCID
50
*
Mumps virus
1
Jeryl Lynn™ [Level B] strain (live, attenuated)………not less
than 12.5x10
3
CCID
50
*
Rubella virus
2
Wistar RA 27/3 strain (live, attenuated) ………………….not
less than 1x10
3
CCID
50
*
*50% cell culture infectious dose
1
produced in chick embryo cells.
2
produced in WI-38 human diploid lung fibroblasts.
The vaccine may contain traces of recombinant human albumin (rHA).
This vaccine contains a trace amount of neomycin. See section 4.3.
Excipients with known effect:
The vaccine contains 14.5 mg of sorbitol. See section 4.4.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Powder and solvent for suspension for injection in pre-filled syringe.
Before reconstitution, the powder is a light yellow compact
crystalline cake and the solvent is a clear
colourless fluid.
4. Clinical particulars
4.1 Therapeutic indications
M-M-RVAXPRO is indicated for simultaneous vaccination against measles,
mumps, and rubella in
individuals from 12 months of age (see section 4.2).
M-M-RVAXPRO can be administered to infants from 9 months of age under
special circumstances (see
sections 4.2, 4.4 and 5.1).
For use in measles outbreaks, or for post-exposure vaccination, or,
for use in previously unvaccinated
individuals older than 9 months who are in contact with susceptible
pregnant women and persons likely to
be susceptible to mumps and rubella, see section 5.1.
M-M-RVAXPRO is to be used on the basis of official recommendations.
4.2 Posology and method of administration
Posology
Individuals 12 months of age or older:
Individuals 12 months