RYALTRIS NASAL SPRAY 60025MCG

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

MOMETASONE FUROATE MONOHYDRATE (MICRONIZED) EQV TO MOMETASONE FUROATE; OLOPATADINE HCL EQV TO OLOPATADINE

Available from:

LOTUS INTERNATIONAL PTE. LTD.

ATC code:

R01AD59

Pharmaceutical form:

SPRAY, SUSPENSION

Composition:

MOMETASONE FUROATE MONOHYDRATE (MICRONIZED) EQV TO MOMETASONE FUROATE 25 MCG/SPRAY; OLOPATADINE HCL EQV TO OLOPATADINE 600 MCG/SPRAY

Administration route:

NASAL

Prescription type:

Prescription Only

Manufactured by:

Glenmark Pharmaceuticals Limited

Authorization status:

ACTIVE

Authorization date:

2022-06-28

Patient Information leaflet

RYALTRIS
® (OLOPATADINE AND MOMETASONE FUROATE NASAL SPRAY 600 MCG/25 MCG) QUALITATIVE AND QUANTITATIVE COMPOSITION
Each spray delivers:
Olopatadine hydrochloride USP
equivalent to Olopatadine ….. 600 mcg
Mometasone furoate monohydrate Ph.Eur. equivalent to
Mometasone furoate. ……..25 mcg
Preservative:
Benzalkonium chloride NF----20mcg
Excipient with known effect:
One actuation delivers 0.02 mg benzalkonium chloride.
DESCRIPTION
A white homogenous suspension free of lumps, crimp-sealed with a nasal
spray pump and
fitted with a white actuator and purple overcap. The bottle is free of
residue, stains, cracks,
dents, discolouration or flash or other visible defects.
PHARMACEUTICAL FORM
Nasal Spray, Suspension
CLINICAL PARTICULARS
INDICATIONS
RYALTRIS
®
is indicated for the treatment of moderate to severe symptoms
associated with allergic
rhinitis and rhinoconjunctivitis in patients 12 years of age and
older.
ACTION AND CLINICAL PHARMACOLOGY
Pharmacotherapeutic group: Decongestants and other nasal preparations
for topical use.
ATC code: R01AD59
MECHANISM OF ACTION
RYALTRIS
®
contains
both
olopatadine
hydrochloride
and
mometasone
furoate;
therefore,
the
mechanisms of action described below for the individual components
would apply to RYALTRIS
®
.
These drugs represent 2 different classes of medications (histamine
H1-receptor antagonist and
synthetic corticosteroid)
_Olopatadine Hydrochloride _
Olopatadine is a histamine H1-receptor antagonist. The antihistaminic
activity of olopatadine has been
documented in isolated tissues, animal models, and humans.
_Mometasone Furoate _
Mometasone furoate is a glucocorticosteroid with local
anti-inflammatory properties at doses that are
minimally systemically active.
PHARMACODYNAMICS
CLINICAL TRIALS
_ADOLESCENTS AND ADULTS (12 YEARS OF AGE AND OLDER) _
The efficacy and safety of RYALTRIS
®
in adults and adolescents 12 years of age and older with
allergic rhinitis were evaluated in 4 studies (GSP 301-201, GSP
301-301, GSP 301-303 and GSP 301-
304).
2-WEEK STUDIES
Three (G

Summary of Product characteristics

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PRINT COLOURS
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REGULATORY APPROVAL
MOMETASONE_OLOPATADINE
SINGAPORE 25MCG_600MCG NASAL
SPRAY PIL
Die Cut size
Created
Modified
Proof round
ART Code
2 Pages - 380x320mm
RM 05/04/2023
RM 27/07/2023
04
ARTDB023764P
_For the use of registered medical practitioner or a hospital or a
laboratory_
(Olopatadine and Mometasone
Furoate Nasal Spray
600 mcg/25 mcg)
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each spray delivers:
Olopatadine hydrochloride USP
equivalent to Olopatadine
600 mcg
Mometasone furoate monohydrate Ph.Eur. equivalent to
Mometasone furoate
25 mcg
Preservative:
Benzalkonium chloride NF
20mcg
Excipient with known effect:
One actuation delivers 0.02 mg benzalkonium chloride.
DESCRIPTION
A white homogenous suspension free of lumps, crimp-sealed with a nasal
spray
pump and fitted with a white actuator and purple overcap. The bottle
is free of residue,
stains, cracks, dents, discolouration or flash or other visible
defects.
PHARMACEUTICAL FORM
Nasal Spray, Suspension
CLINICAL PARTICULARS
INDICATIONS
RYALTRIS® is indicated for the treatment of moderate to severe
symptoms associat-
ed with allergic rhinitis and rhinoconjunctivitis in patients 12 years
of age and older.
ACTION AND CLINICAL PHARMACOLOGY
Pharmacotherapeutic group: Decongestants and other nasal preparations
for topical
use.
ATC code: R01AD59
MECHANISM OF ACTION
RYALTRIS® contains both olopatadine hydrochloride and mometasone
furoate;
therefore, the mechanisms of action described below for the individ