OTRIVIN

Krajina: Izrael

Jazyk: angličtina

Zdroj: Ministry of Health

Aktívna zložka:

XYLOMETAZOLINE HYDROCHLORIDE

Dostupné z:

GSK CONSUMER HEALTHCARE, ISRAEL LTD

ATC kód:

R01AA07

Forma lieku:

NASAL SOLUTION

Zloženie:

XYLOMETAZOLINE HYDROCHLORIDE 0.1 %W/V

Spôsob podávania:

NASAL

Typ predpisu:

Not required

Výrobca:

NOVARTIS CONSUMER HEALTH SA, SWITZERLAND

Terapeutické skupiny:

XYLOMETAZOLINE

Terapeutické oblasti:

XYLOMETAZOLINE

Terapeutické indikácie:

Rapid relief of nasal congestion for up to ten hours in adults and adolescents aged 12 years and older.

Dátum Autorizácia:

2014-07-31

Príbalový leták

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS
’ REGULATIONS
)
PREPARATIONS
(
–
This
edi
i
e is dispesed ithout a do to ’s p es
iptio
OT I
I
NASAL SOLUTIO D OPS .
% /
OT I
I
NASAL SOLUTIO METE ED DOSE
SP A
.
% /
OT I
I
NASAL SOLUTIO SP A .
% /
A TI E I
G EDIE T A D ITS O
E T ATIO
X LO
ETAZOLI
E H D O HLO IDE .
% /
I
a ti e i
g ediets a d alleges i
the p epa atio – please see setio a d setio
)
I
po ta t
i
fo
atio a out so
e of the i
g ediets of the
edi
i
e
(
.
READ THE ETI E LEAFLET A EFULL EFO E USI
G THE EDI
I
E. This leaflet o tai
s o
ise i
fo
atio
a out the
edi
i
e. If ou ha e a
othe uestio s, efe to the do to o the pha
a ist. Use the
p epa atio a
o di
g to the i
st u tio s i
the dosage setio of this leaflet. Co sult the pha
a ist
if ou
eed
o e i
fo
atio . Refe to the do to if sig s of the ail
et
)
s
pto
s
(
o se o do
ot i
p o e afte da s.
. WHAT IS THE EDI
I
E I
TE DED FO ?
The
edi
i
e is i
teded fo apid elief of asal o gestio fo up to hou s i
adults a d
adoles ets o e ea s old.
THE APEUTI LASS:
Ot i
i
o tai
s lo
etazoli
e h d o hlo ide, hi
h elo gs to the
lass of s
patho
i
eti
agets. Ot i
i
helps ope a d lea the
asal passages edu i
g the fo
atio of e ess
asal
se etio s a d etu
i
g the s
olle
lood essels to thei
o igi
al size.
. BEFO E USI
G THE EDI
I
E
DO OT USE THE P EPA ATIO IF:
•
You a e se siti e
)
allegi
(
to the a ti e i
g ediet
)
lo
etazoli
e h d o hlo ide
(
o to a
o e of the othe i
g ediets the
edi
i
e
o tai
s – please see setio .
•
You a e afte a t a s-sphe oidal esetio
)
th ough the
asal
a it
(
of the pituita
gla d o
a opeatio du i
g hi
h the oute
ei
ges of the
et al e
ous s ste
ee eposed.
•
You ha e
a
o
a gle glau o
a.
•
You ha e h o i
asal i
fla
atio ith
e
d
asal passages
)
hi
itis si
a o at ophi
hi
itis
(
.
•
You ha e a e la ged p ostate gla d.
•
You ha e a a e tu
o i
the ad eal gla d that p odu es e ess ad eali
e a d
o ad eali
e
)
pheo h o
o
to
a
(
.
•
You a e taki
g edi
i
es that i
hi
it the e z
e
o oa
i
e o idase
)
MAO i
hi
ito s
(
o if
ou ha e stopped taki
g the i

Súhrn charakteristických

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
OTRIVIN
OTRIVIN
OTRIVIN
NASAL SOLUTION
NASAL SOLUTION
NASAL SOLUTION
DROPS 0.1% w/v
SPRAY 0.1% w/v
METERED DOSE SPRAY
0.1% w/v
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient: 0.1% w/v Xylometazoline Hydrochloride
For excipients see 6.1
3.
PHARMACEUTICAL FORM
OTRIVIN NASAL SOLUTION DROPS
Nasal drops, solution;
A clear, colourless solution
OTRIVIN NASAL SOLUTION SPRAY
Nasal spray Solution;
A clear, colourless solution
OTRIVIN NASAL SOLUTION METERED DOSE SPRAY
Nasal spray, solution
A clear, colourless solution
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Rapid relief of nasal congestion for up to ten hours
adults and adolescents aged
12 years and older.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_OTRIVIN NASAL SOLUTION DROPS: _
Adults and adolescents over 12 years of age: 2-3 drops in each
nostril, every
8-10 hours, as necessary.
Do not exceed a dosage of 3 daily applications in each nostril.
Route of administration: Nasal use
_OTRIVIN NASAL SOLUTION SPRAY: _
Adults and adolescents over 12 years of age: 1 inhalation in each
nostril,
every 8-10 hours, as necessary.
Do not exceed 3 daily applications in each nostril.
Route of administration: Nasal use
_OTRIVIN NASAL SOLUTION METERED DOSE SPRAY: _
Adults and adolescents over 12 years of age: 1 inhalation in each
nostril,
every 8-10 hours, as necessary.
Do not exceed 3 daily applications in each nostril.
Route of administration: Application to the nasal passages.
Before the first application, prime the pump by actuating 4 times.
Once
primed, the
pump will normally remain charged throughout regular daily treatment
periods.
If the spray is not ejected during the full actuation stroke, or if
the product has
not been used for longer than 7 days, the pump will need to be
reprimed with
4 actuations.
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in
section 6.1.
Patients with trans-sphenoidal hypophysectomy or surgery exposing the
dura
mat