Dymista spray nasal (suspension)

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

azelastine(azelastine hydrochloride), fluticasone (fluticasone propionate)

Available from:

MEDA Pharma GmbH & Co. KG

ATC code:

R01AD58

INN (International Name):

azelastine(azelastine hydrochloride), fluticasone (fluticasone propionate)

Dosage:

137mcg/dose+ 50mcg/dose

Pharmaceutical form:

spray nasal (suspension)

Units in package:

23g (17ml suspension/not less than 120 doses) glass bottle with dispenser

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2017-09-05

Summary of Product characteristics

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Translation
Wording of the information intended for the summary of product
characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Dymista Nasal Spray
137 micrograms / 50 micrograms per actuation
Nasal Spray, Suspension
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g of suspension contains 1000 micrograms azelastine hydrochloride
and
365 micrograms fluticasone propionate.
One actuation (0.14 g) delivers 137 micrograms azelastine
hydrochloride
(= 125 micrograms azelastine) and 50 micrograms fluticasone
propionate.
Excipient(s) with known effect:
One actuation (0.14 g) delivers 0.014 mg benzalkonium chloride.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Nasal spray, suspension.
White, homogeneous suspension.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Relief of symptoms of moderately severe to severe seasonal and
perennial allergic rhi-
nitis if monotherapy with either intranasal antihistamine or
glucocorticoid is not consid-
ered sufficient.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_POSOLOGY _
For full therapeutic benefit regular usage is essential.
Contact with the eyes should be avoided.
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Adults and adolescents (12 years and older)
One actuation in each nostril twice daily (morning and evening).
Children below 12 years
Dymista 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 patients
No dose adjustment is required in this population.
Patients with renal and hepatic impairment
There are no data on patients with renal or hepatic impairment (see
section 4.4)._ _
_DURATION OF TREATMENT _
Dymista Nasal Spray is suitable for long-term use.
The duration of treatment should correspond to the period of
allergenic exposure.
_METHOD OF ADMINISTRATION _
Dymista Nasal Spray is for nasal use only.
_INSTRUCTION FOR USE _
Preparing the spray:
The bottle s