Alisade
Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Fuljett ta 'informazzjoni
(PIL)
05-03-2010
Karatteristiċi tal-prodott
(SPC)
05-03-2010
Rapport ta 'Valutazzjoni Pubblika
(PAR)
11-06-2009
Ingredjent attiv:
fluticasone furoate
Disponibbli minn:
Glaxo Group Ltd.
Kodiċi ATC:
R01AD12
INN (Isem Internazzjonali):
fluticasone furoate
Grupp terapewtiku:
Nasal preparations
Żona terapewtika:
Rhinitis, Allergic, Perennial; Rhinitis, Allergic, Seasonal
Indikazzjonijiet terapewtiċi:
Adults, adolescents (12 years and over) and children (6 - 11 years). Alisade is indicated for the treatment of the symptoms of allergic rhinitis.
Sommarju tal-prodott:
Revision: 4
L-istatus ta 'awtorizzazzjoni:
Withdrawn
Data ta 'l-awtorizzazzjoni:
2008-10-06
Fuljett ta 'informazzjoni
MEDICINAL PRODUCT NO LONGER AUTHORISED
16
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
INTRANASAL SPRAY/DEVICE LABEL
1.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION
Alisade 27.5 micrograms/spray nasal spray suspension
Fluticasone fuorate
2.
METHOD OF ADMINISTRATION
Read the package leaflet before use
3.
EXPIRY DATE
_ _
_EXP {MM/YYYY]_
4.
BATCH NUMBER
_ _
_LOT {Number}_
5.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
30 sprays
60 sprays
120 sprays
6.
OTHER
MEDICINAL PRODUCT NO LONGER AUTHORISED
17
B. PACKAGE LEAFLET
MEDICINAL PRODUCT NO LONGER AUTHORISED
18
PACKAGE LEAFLET: INFORMATION FOR THE USER
ALISADE 27.5 MICROGRAMS PER SPRAY NASAL SPRAY SUSPENSION
Fluticasone furoate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
-
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. Never pass it on to others.
It may harm them, even if
their symptoms seem the same as yours.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
tell your doctor or pharmacist.
IN THIS LEAFLET
:
1.
WHAT ALISADE IS AND WHAT IT IS USED FOR
2.
BEFORE YOU USE ALISADE
3.
HOW TO USE ALISADE
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE ALISADE
6.
FURTHER INFORMATION
STEP-BY-STEP GUIDE TO USING THE NASAL SPRAY
1.
WHAT ALISADE IS AND WHAT IT IS USED FOR
Alisade nasal spray is used to treat symptoms of allergic rhinitis
including stuffy, runny or itchy nose,
sneezing and watery, itchy or red eyes, in adults and children aged 6
years and over.
Allergy symptoms can occur at specific times of the year and be caused
by allergy to pollen from grass
or trees (hayfever), or they can occur all year round and be caused by
allergy to animals, house-dust
mites or moulds.
Alisade belongs to a group of medicines called
_glucocorticoids_
.
Alisade works to decrease inflammation caused by allergy (
_rhinitis_
).
2.
BEFORE YOU USE ALISADE
DO NOT USE ALISAD
Aqra d-dokument sħiħ
Karatteristiċi tal-prodott
MEDICINAL PRODUCT NO LONGER AUTHORISED
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
MEDICINAL PRODUCT NO LONGER AUTHORISED
2
1.
NAME OF THE MEDICINAL PRODUCT
ALISADE 27.5 micrograms/spray
nasal spray suspension
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each spray actuation delivers 27.5 micrograms of fluticasone furoate.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Nasal spray, suspension.
White suspension.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Adults, adolescents (12 years and over) and children (6 – 11 years)
Alisade is indicated for the treatment of:
• the symptoms of allergic rhinitis
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Fluticasone furoate nasal spray is for administration by the
intranasal route only.
For full therapeutic benefit regular, scheduled usage is recommended.
Onset of action has been
observed as early as 8 hours after initial administration. However, it
may take several days of
treatment to achieve maximum benefit, and the patient should be
informed that their symptoms will
improve with continuous regular use (see section 5.1). The duration of
treatment should be restricted
to the period that corresponds to allergenic exposure.
Adults and Adolescents (12 years and over)
The recommended starting dose is two spray actuations (27.5 micrograms
of fluticasone furoate per
spray actuation) in each nostril once daily (total daily dose, 110
micrograms).
Once adequate control of symptoms is achieved, dose reduction to one
spray actuation in each nostril
(total daily dose 55 micrograms) may be effective for maintenance.
The dose should be titrated to the lowest dose at which effective
control of symptoms is maintained.
Children (6 to 11 years of age)
The recommended starting dose is one spray actuation (27.5 micrograms
of fluticasone furoate per
spray actuation) in each nostril once daily (total daily dose, 55
micrograms).
Patients not adequately responding to one spray actuation in each
nostril once daily (total daily dose,
55 micrograms) may use two spray
Aqra d-dokument sħiħ
