Mirvaso 3mg/g gel gel

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

brimonidine (brimonidine tartrate)

Available from:

Laboratoires Galderma Z.I. Montdesir

ATC code:

D11AX21

INN (International Name):

brimonidine (brimonidine tartrate)

Dosage:

3,3mg/g

Pharmaceutical form:

gel

Units in package:

2g, 10g and 30g laminated or polyfoil plastic tube

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2015-12-02

Patient Information leaflet

B.
PACKAGE
LEAFLET
GALDERMA
SA
Av.
Gratta-Paille
2
CH
-
1018
Lausanne
Package
leaflet:
Information for
the
patient
Mirvaso
3
mglg
gel
brimonidine
Read
all
of
this
leaflet
carefully
before
you
start
using
this
medicine
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.
-
This
medicine
has
been
prescribed
for
you
only. Do
not
pass
it
on
to
others.
It
may harm them,
even
iftheir
signs
ofillness
are
the
same as
yours.
-
Ifyou
get
any
side
effects,
talk to
your
doctor.
This hcludes
any
possible
side
effects not
listed
in this leaflet.
See
section
4.
What
is
in this leaflet
1.
What Mirvaso
is
and
what
it
is used
for
2.
What
you
need
to know
before
you
use
Mirvaso
3.
How
to
use
Mirvaso
4.
Possible side effects
5.
How to
store
Mirvaso
6.
Contents
ofthe
pack
and
other
information
1.
What
Mirvaso
is
and
what
it
is used
for
Mirvaso
contains
the
active
substance
brimonidine which
belongs
to
a
group
of
medicines
commonly
referred
to
as
"alpha
agonists".
It
is
applied
to
the skin
ofthe
face
to
treat
redness due
to
rosacea
in
adult
patients.
Redness
of
the
face due
to
rosacea
is
caused
by
high
Ievels
of
blood
flow
in
the
facial skin. which
is
the
result
of
enlargement
(dilation)
ofthe
small
blood
vessels
ofthe
skin.
When applied,
Mirvaso
acts
to
narrow
these
blood
vessels
again
which
reduces the excess
blood
flow
and redness.
2.
What
you
need
to
know
before
you
use
Mirvaso
Do
not
use
Mirvaso:
-
ifyou
are
allergic to brimonidine
or any
ofthe
other ingredients
ofthis
medicine
(listed
in
section 6).
-
in
children below
2
years
of
age,
who
may be
at
greater
risk
of
side
effects
from
any
of
the
medicine
absorbed
through the skin.
-
ifyou
are
taking
certain medicines
used
for
depression
or
Parkinson's
disease
including
so-called monoamine
oxidase
(MAO)
inhibitors
(for
example selegiline
or
moclobemide)
or
tricyclic
antidepressants
(such
as
imipramine)
or
tetracyclic
antidepressants
(such
as
maprotiline,
mianserin or
mirtazapin).

Summary of Product characteristics

A}INEX
I
SIJMMARY
OF
PRODUCT
CHARACTERISTICS
GALDERMA
SA
Av.
Gratta-Paille
2
CH
-
1018
Lausanne
1.
NAMEOFTHEMEDICINALPRODUCT
Mirvaso
3
mglg
gel
2.
QUALITATIVE
AND
QUANTITATN'E
COMPOSITION
One
gram
ofgel
contains
3.3
mg
of brimonidine,
equivalent
to
5
mg
of brimonidine
tartrate.
Excipient(s)
with
known effect:
One
gram
ofgel
contains
I
mg
methylparahydroxltenzoate
@218)
and 55
mg
propylene glycol.
For the
full
list
of excipients,
see
section
6.1.
3.
PHARMACEUTICALFORM
Gel.
White to
iight
yellow
opaque aqueous
gel.
4.
CLINICALPARTICT]LARS
4.1
Therapeuticindications
Mirvaso
is indicated
for
the
rymptomatic
treatment
of
facial
erythema
of
rosacea
in
adult
patients.
4.2
Posology
and method
of
administration
Posoloev
One
application
per
24
hours,
at
any
time
suitable
for
the
patient,
for
as
long
as
facial erlthema
is
present.
The
maximum daily
recommended
dose
is
1
g
ofgel
in total weight, divided into five
pea
size
amounts.
Soecial
populations
Elderly
patients
The experience
ofuse
of Mirvaso
in
patients
aged
above.65
years
is
limited
(see
also
section
4.8).
Paediatic
population
The safety
and
efficacy of
Mirvaso in
children
and adolescents aged
less
than
18
years
have
not
been
established.
No
data are
available.
Mirvaso
is contraindicated
in children
aged
less
than
2
years
because
of
serious systemic safety
risk
(see
section
4.3).
Safety
concems related
to the systemic absorption
of brimonidine
have
also
been
identifred
for
the
age
group
2
to
12
years (see
section 4.9).
Mirvaso
should not
be used
in
children
or
adolescents aged 2
to
18
years.
GALDERMA
SA
Av.
Gratta-Paille
2
CH
-
1018 Lausanne
Method of administration
Cutaneous
use
only.
Cutaneous
application
ofa
small
pea
size
amount
of medicinal
product
to
each
ofthe
five
areas
ofthe
face: forehead, chin,
nose, each cheek.
Mirvaso
should
be
applied
smoothly
and
evenly
as
a
thin layer
across the
entire
face
avoiding
the
eyes,
eyelids,
lips, mouth
and
membrane
ofthe
inner
nose.
Mirvaso
should
be
applied
only to
the
face.
Hands
should
be
washed
immediately
after
applyin