RYALTRIS olopatadine 600 microgram/actuation and mometasone furoate 25 microgram/actuation nasal spray bottle

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

유효 성분:

olopatadine hydrochloride, Quantity: 665 microgram/actuation (Equivalent: olopatadine, Qty 600 microgram/actuation); mometasone furoate monohydrate, Quantity: 25.86 microgram/actuation (Equivalent: mometasone furoate, Qty 25 microgram/actuation)

제공처:

Seqirus Pty Ltd

약제 형태:

Spray, nasal

구성:

Excipient Ingredients: sodium chloride; hydrochloric acid; carmellose sodium; sodium hydroxide; dibasic sodium phosphate heptahydrate; dispersible cellulose; benzalkonium chloride; water for injections; polysorbate 80; disodium edetate

관리 경로:

Nasal

패키지 단위:

240 doses per bottle, 56 doses per bottle, 56 doses per bottle (Starter pack), 120 doses per bottle

처방전 유형:

(S4) Prescription Only Medicine

치료 징후:

RYALTRIS is indicated for the treatment of symptoms associated with allergic rhinitis and rhinoconjunctivitis in patients 6 years of age and older.

제품 요약:

Visual Identification: Aqueous white homogenous suspension filled into a white opaque high density polyethylene bottle, fitted with spray pump, nasal actuator and dust cap.; Container Type: Bottle, with integral pump - manual actuated; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

승인 상태:

Registered

승인 날짜:

2019-12-11

환자 정보 전단

RYALTRIS
®
NASAL SPRAY
Page 1 of 6
RYALTRIS
®
NASAL SPRAY
(rye – al’ – tris)
_Olopatadine hydrochloride and mometasone furoate monohydrate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about
RYALTRIS

nasal
spray
.
This leaflet does not contain all the
available information and it does
not take the place of talking to your
doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this
medicine against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS
ABOUT USING THIS MEDICINE, ASK
YOUR DOCTOR OR PHARMACIST.
Keep this leaflet with the
medicine. You may want to read it
again.
WHAT RYALTRIS
 IS
USED FOR
RYALTRIS

contains the active
ingredients olopatadine
hydrochloride and mometasone
furoate monohydrate.
Olopatadine hydrochloride is an
antihistamine that reduces the
effects of histamine, a natural
chemical in the body. Histamine can
make you sneeze, have itchy or
watery eyes, and runny nose.
Mometasone furoate monohydrate
belongs to a family of medicines
called corticosteroids, which are
used to help reduce inflammation.
RYALTRIS

is sprayed into the
nose to treat the symptoms of
allergic rhinitis (hay fever or other
year round allergies) and
rhinoconjunctivitis (allergy defined
by symptoms in the nose and
eyes).
RYALTRIS

relieves symptoms of
allergies, including stuffiness
(congestion) in the nose, runny
nose, itchy nose, sneezing, as well
as watering, itching and redness of
the eye.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED FOR
YOU.
Your doctor may have prescribed it
for another reason.
There is no evidence that this
medicine is addictive.
This medicine is available only
with a doctor's prescription.
There is not enough information to
recommend the use of this
medicine
for children under the age of 6
years.
BEFORE YOU USE
RYALTRIS

_WHEN YOU MUST NOT USE IT_
DO NOT USE THE MEDICINE IF:
1. YOU HAVE AN ALLERGY TO:
•
any m

제품 특성 요약

Ryaltris
®
Product Information
Page 1 of 24
AUSTRALIAN PRODUCT INFORMATION - RYALTRIS®
(OLOPATADINE HYDROCHLORIDE AND
MOMETASONE FUROATE MONOHYDRATE) NASAL SPRAY
1
NAME OF THE MEDICINE
Olopatadine hydrochloride and mometasone furoate monohydrate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each spray delivers a volume of 0.1 mL suspension containing 600
micrograms (0.6%w/v) of
olopatadine equivalent to 665 micrograms of olopatadine hydrochloride
and mometasone
furoate monohydrate equivalent to 25 micrograms (0.025% w/v) of
mometasone furoate
(665 micrograms / 25 micrograms).
Excipients with known effect: polysorbate 80 and benzalkonium
chloride.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
RYALTRIS® is a nasal spray containing an isotonic aqueous white
homogenous suspension in
a metered dose manual spray unit. It has a pH of approximately 3.7.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
RYALTRIS® is indicated for the treatment of symptoms associated with
allergic rhinitis and
rhinoconjunctivitis in patients 6 years of age and older.
4.2
DOSAGE AND ADMINISTRATION
DOSAGE
ADULTS AND ADOLESCENTS (12 YEARS OF AGE AND OLDER)
The recommended dosage of RYALTRIS® is 2 sprays in each nostril twice
daily.
CHILDREN (6 TO 11 YEARS OF AGE)
The recommended dosage of RYALTRIS® is 1 spray in each nostril twice
daily.
METHOD OF ADMINISTRATION
Administer RYALTRIS® by the intranasal route only. Shake the bottle
well before each use.
Priming: Prime RYALTRIS® before initial use by releasing 6 sprays.
One bottle of RYALTRIS®
provides either 240, 120 or 56 metered sprays after priming, depending
on the bottle
presentation. When RYALTRIS® has not been used for ≥14 days,
re-prime by releasing 2
sprays or until a fine mist appears.
Ryaltris
®
Product Information
Page 2 of 24
Depending on the presentation, the bottle should be discarded after
240 sprays (30 days
usage for adults and adolescents 12 years and older OR 60 days usage
for children 6 to 11
years old), 120 sprays (15