Otrepin-Arpi spray nasal

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

xylometazoline (xylometazoline hydrochloride)

Available from:

Arpimed LLC

ATC code:

R01АA07

INN (International Name):

xylometazoline (xylometazoline hydrochloride)

Dosage:

1mg/ml

Pharmaceutical form:

spray nasal

Units in package:

15ml plastic bottle with pump dispenser

Prescription type:

OTC

Authorization status:

Registered

Authorization date:

2017-07-10

Summary of Product characteristics

SUMMARY
PRODUCT
CHARACTERISTIC
Otrepin-Arpi
Spray
nasal,
metered-dose
0.17o
l.l.TRAIlE
NAME
-Otrepin-ArPi
I
"2.
INTSRNATIONAL
NON-PROPERTY
NAME
-
Xylometazoline
2.
QUALITATTVE
AND
QUANTITATIVE
COMPOSITION
Eachl
rnl
of
Otrepin-Arpi,
spray
nasal,
metered-dose0-l%contains:
Aetive
ingredient:Xylometazoline
hydrochloride
-
1
*g;
For
afull
list
of
excipients,
see
section
6.1.
3.
PHARMACEUTICAL
FORM
Spraynasal,
m
etered-dose.
Clear
solution,
with
menthol
and
eucalyptol
(cineole)
odour.
4.
CLINICAL
PARTICULARS
4.
I
Therapeutic
indications
For
the
sy-mptomatic
relief
of
nasal
congestion,
perennial
and
altergic
rhinitis
(including
hay
fever),
sinusitis.
4.2 Posology
and
method
of
administration
Posologt
Paediatri!
population
Otrepin-Arpishould
not be
used
in children
aged
less
than
12
years
old.
adminiitration
The
rnetereddose
spray
pennits
accuracy
of
dosage
and
ensures
that
the
solution
is
well
distributed
over
the
surlace
of
tie
nasal
mucosa.
it
precludes the
possibility
of
unintentional
overdose.
Before
the
first
application,
prime
the
pump
by
actuating
4
times.
Once
primed
thg
Ruml
will
normally
remain
charged
tilnughout
regular
daily
ueatment
periods.
Should
the
spray
not
be
ejected
during
the
full
actuatioi
sroke,
tte
pump
will
need
to
be
reprimed
with
the
same
number
of
actuations
as
initially
performed.
Be
carefii
not
to
spray
in
the
eYes.
I.
Blow
the
nose
gently.
2.
Rernove
protective
cap.
3.
Do
not
cut
the
nozzle.
The
metered-dose
spray
is ready
to
prime
before
use.
4.
Hold
the bottle
upright
with
thumb
under
base
and
nozzle
between
two
fingers.
5.
Lean
forward
slightly
and
insert
the
nozzle
into
a
nostril.
6.
Spray
and
breathe
in
gently
through
the
nose
at
the
same
time.
7. Repeat
in
the
other
nostril.
g.
Clian
and
dry
the
nozzle
before
replacing
back
the cap
right
after
use.
To
avoid
possible
spread
of
infection,
the
spray
should
only
be
used
by
one
person.
't
Method
Strength
Age
Fosology
J.1%
Adults
and
adolescentsover
12
years
ofage
I
spray
into
each
nostril,
I
to
3
times
daily
as
needed.
Do
not
exceed
3
app