Vivispray 1mg/ml Nasal Spray Solution

מדינה: מלטה

שפה: אנגלית

מקור: Malta Medicines Authority

מרכיב פעיל:

AZELASTINE HYDROCHLORIDE

זמין מ:

Bausch + Lomb Ireland Limited 3013 Lake Drive Citywest Business Campus Dublin 24, D24PPT, Ireland

קוד ATC:

R01AC03

INN (שם בינלאומי):

AZELASTINE HYDROCHLORIDE 0.14 mg

טופס פרצבטיות:

NASAL SPRAY, SOLUTION

הרכב:

AZELASTINE HYDROCHLORIDE 0.14 mg

סוג מרשם:

POM

איזור תרפויטי:

NASAL PREPARATIONS

מצב אישור:

Authorised

תאריך אישור:

2017-11-23

עלון מידע

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
VIVISPRAY 1 MG/ML NASAL SPRAY, SOLUTION
Azelastine hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
Legal status: POM
WHAT IS IN THIS LEAFLET
1.
What Vivispray
is and what it is used for
2.
What you need to know before you use Vivispray
3.
How to use Vivispray
4.
Possible side effects
5.
How to store Vivispray
6.
Contents of the pack and other information
1.
WHAT VIVISPRAY IS AND WHAT IT IS USED FOR
Vivispray
contains azelastine, which belongs to a group of medicines that works
by preventing the
effect of histamine (antihistamines) and other substances that the
body produces as part of an allergic
reaction, usually it affects you by causing a runny nose, sneezing,
itching or blocked nose. Azelastine
has also an additional antiinflammatory effect.
Vivispray
is used for the symptomatic treatment of seasonal allergic rhinitis,
and acute exacerbations
(attacks) of perennial allergic rhinitis.
Vivispray
nasal spray is intended for use by adults and children over 6 years of
age.
[For member states where the medicinal product is available on
prescription only:]
You must talk to a doctor if you do not feel better or if you feel
worse after 4 weeks.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE VIVISPRAY
_ _
DO NOT USE VIVISPRAY:
-
if you are allergic to azelastine hydrochloride or any of the other
ingredients of this medicine
(listed in section 6).
Vivispray
nasal spray must not be used by children under the age of 6. The
instructions for
adolescents are the same as for adults (see

מאפייני מוצר

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SUMMARY OF PRODUCT CHARACTERISTICS (SMPC)
1.
NAME OF THE MEDICINAL PRODUCT
VIVISPRAY
1 mg/ml nasal spray, solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains 1mg azelastine hydrochloride.
One application (0.14 mL) contains 0.14 mg azelastine hydrochloride
equivalent to 0.13 mg
azelastine.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Nasal spray, solution.
Clear colourless solution.
The pH of the solution is between 6.4 -7.2
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Azelastine is indicated for the symptomatic treatment of seasonal
allergic rhinitis (e.g hayfever) and
acute exacerbations of perennial allergic rhinitis in adults,
adolescents and children from 6 years of
age.
_ _
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Route of application is topical – nasal mucosa.
One application (0.14 ml) in each nostril twice daily (0.56 mg of
azelastine hydrochloride).
There have been no specific studies in the elderly.
For children aged 6 years and older, one application (0.14 ml) in each
nostril twice daily (0.56 mg of
azelastine hydrochloride).
Azelastine should not be used in children below 6 years of age due to
lack of data on safety and
efficacy.
Method of administration
Nasal use
_Precautions to be taken before handling or administering the
medicinal product: _
Spray with head held upright.
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Before the first use, press the pump several times until an even spray
emerges (3-4 times).
When azelastine has not been used for 6 or more days, the pump must be
reprimed by pressing down
and releasing the pump a sufficient number of times until a fine mist
emerges.
After administration, wipe the pump nozzle and replace the protective
cap.
4.3
CONTRAINDICATIONS
Children under 6 years of age.
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
The spray should be used with the head held upright, see section 4.8.
_ _
4.5
INTERACTION WITH OTHER MEDICINAL PRODU