DYMISTA ALLERGY azelastine (as hydrochloride) 125 microgram/actuation and fluticasone propionate 50 microgram/actuation nasal spray bottle

国家: 澳大利亚

语言: 英文

来源: Department of Health (Therapeutic Goods Administration)

有效成分:

fluticasone propionate, Quantity: 50 microgram/actuation; azelastine hydrochloride, Quantity: 137 microgram/actuation (Equivalent: azelastine, Qty 125 microgram/actuation)

可用日期:

Viatris Pty Ltd

药物剂型:

Spray, nasal

组成:

Excipient Ingredients: phenethyl alcohol; benzalkonium chloride; purified water; microcrystalline cellulose; polysorbate 80; carmellose sodium; glycerol; disodium edetate

给药途径:

Nasal

每包单位数:

17 mL

处方类型:

(S2) Pharmacy Medicine

疗效迹象:

Symptomatic treatment of moderate to severe allergic rhinitis for up to 6 months.

產品總結:

Visual Identification: White, homogeneous, redispersible suspension filled into Type I amber glass bottles fitted with a spray pump, nasal applicator and dust cap.; Container Type: Aerosol - Pump Actuated Metered Dose; Container Material: Glass Type I Coloured; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Restricted flow insert

授权状态:

Registered

授权日期:

2023-04-03

资料单张

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ACTIVE INGREDIENT(S): _azelastine (as hydrochloride)/fluticasone
propionate_
CONSUMER MEDICINE INFORMATION (CMI)
This leaflet provides important information about using
DYMISTA ALLERGY. YOU SHOULD ALSO SPEAK TO
YOUR DOCTOR OR PHARMACIST IF YOU WOULD LIKE FURTHER
INFORMATION OR IF YOU HAVE ANY CONCERNS OR QUESTIONS
ABOUT USING DYMISTA ALLERGY.
WHERE TO FIND INFORMATION IN THIS LEAFLET:
1. Why am I using DYMISTA ALLERGY Nasal Spray?
2. What should I know before I use DYMISTA ALLERGY Nasal
Spray?
3. What if I am taking other medicines?
4. How do I use DYMISTA ALLERGY Nasal Spray?
5. What should I know while using DYMISTA ALLERGY Nasal
Spray?
6. Are there any side effects?
7. Product details
1.
WHY AM I USING DYMISTA ALLERGY?
DYMISTA ALLERGY Nasal Spray is sprayed into the nose to
treat moderate to severe allergic rhinitis (hayfever and other
allergies affecting the nose) for up to 6 months in adults and
children 12 years and older. It relieves sneezing and runny,
itchy, or blocked nose.
Hayfever is an inflammation or swelling of the nose lining
(which may cause blockage, runny nose, itching and/ or
sneezing).
You may have symptoms only during spring or summer. This
type of allergy is generally due to various pollens. Some
people may experience symptoms all year round. This is
usually caused by house dust mites, pets or moulds.
This medicine contains two active ingredients: azelastine
hydrochloride and fluticasone propionate.
Azelastine hydrochloride belongs to a group of medicines
called antihistamines. Antihistamines work by preventing
the effects of substances such as histamine that the body
produces as part of an allergic reaction. This reduces
symptoms of allergic rhinitis.
Fluticasone propionate belongs to a group of medicines
called corticosteroids which are used to help reduce
inflammation.
DYMISTA ALLERGY PROVIDES RAPID NASAL SYMPTOM RELIEF
FROM 5 MINUTES.
2.
WHAT SHOULD I KNOW BEFORE I USE DYMISTA
ALLERGY NASAL SPRAY?
WARNINGS

产品特点

AUSTRALIAN PRODUCT INFORMATION
DYMISTA
® ALLERGY
_azelastine (as hydrochloride) and fluticasone propionate nasal spray
_
1
NAME OF THE MEDICINE
Azelastine (as hydrochloride) and fluticasone propionate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
DYMISTA ALLERGY nasal spray is a fixed combination product containing
the following active ingredients:
azelastine hydrochloride and fluticasone propionate. Each g of
suspension contains 1 mg azelastine hydrochloride
and 0.365 mg fluticasone propionate. One spray (137 mg) contains 125
µg of azelastine (as the base) and 50 µg
of fluticasone propionate.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
DYMISTA
ALLERGY
A white, homogeneous and redispersible suspension.
It is available as a metered-spray suspension for intranasal
administration.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Symptomatic treatment of moderate to severe allergic rhinitis for up
to 6 months.
4.2
DOSE AND METHOD OF ADMINISTRATION
DURATION OF TREATMENT
DYMISTA ALLERGY nasal spray is suitable for use up to 6 months.
DOSAGE
Adults and adolescents (e.g. 12 years and older)
One spray in each nostril twice daily (morning and evening).
For adolescents from 12 – 17 years of age, use only on medical
advice.
Children below 12 years
DYMISTA ALLERGY nasal spray is not recommended for use in children
below 12 years of age as safety and
efficacy has not been established in this age group.
Elderly
No dose adjustment is required in this population (see Sections 5.2
PHARMACOKINETIC PROPERTIES under
Special Populations –
_Age_
and 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE – Use in the
Elderly).
Renal and hepatic impairment
No dose adjustment is required in patients with renal impairment or
mild to moderate hepatic impairment (see
Sections
5.2 PHARMACOKINETIC
PROPERTIES
under
Special
Populations
–
_Renal _
_Impairment _
and
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE – Use in Renal
Impairment).
DYMISTA
®
ALLERGY – PRODUCT INFORMATION
2
Caution
is
requir