FLIXOTIDE DISKUS 100 MCG

מדינה: ישראל

שפה: אנגלית

מקור: Ministry of Health

מרכיב פעיל:

FLUTICASONE PROPIONATE

זמין מ:

GLAXO SMITH KLINE (ISRAEL) LTD

קוד ATC:

R03BA05

טופס פרצבטיות:

POWDER FOR INHALATION

הרכב:

FLUTICASONE PROPIONATE 100 MCG

מסלול נתינה (של תרופות):

INHALATION

סוג מרשם:

Required

תוצרת:

GLAXO WELLCOME PRODUCTION, FRANCE

איזור תרפויטי:

FLUTICASONE

סממני תרפויטית:

Prophylactic management of all grades of asthma.

תאריך אישור:

2021-01-31

עלון מידע

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS)
−
1986
The medicine is dispensed according to a physician’s prescription
only
Flixotide Diskus 100 mcg, Powder for Inhalation
Each dose contains 100 microgram fluticasone propionate,
Flixotide Diskus 250 mcg, Powder for Inhalation
Each dose contains 250 microgram fluticasone propionate,
Flixotide Diskus 500 mcg, Powder for Inhalation
Each dose contains 500 microgram fluticasone propionate
For the list of the inactive and allergenic ingredients in the
medicine, see section
6 –"Additional information”.
Read the leaflet carefully in its entirety before using the medicine.
This leaflet
contains concise information about the medicine. If you have further
questions,
refer to the physician or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may
harm them even if it seems to you that their medical condition is
similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
Flixotide Diskus is used as a preventive treatment for asthma and for
treatment
and reduction of symptoms in chronic obstructive pulmonary disease
(COPD)
when used in combination with long acting bronchodilators.
Only the 250 mcg or 500 mcg strength Flixotide Diskus is suitable for
the
treatment of COPD.
Therapeutic group:
Corticosteroids
Flixotide Diskus contains fluticasone propionate, which belongs to a
group of
medicines called corticosteroids (a group of synthetic hormones, often
called
steroids). Flixotide Diskus works by reducing swelling and irritation
in the lungs.
It has an anti-inflammatory action.
2. BEFORE USING THE MEDICINE
Do not use the medicine if:
•
you are sensitive (allergic) to the active ingredient (fluticasone
propionate),
lactose (which contains milk protein) or to any of the additional
ingredients
contained in this medicine (as listed in section 6).
Special warnings regarding use of the medicine
Before the treatment with Flixotide Diskus, tell the physician if:
•
you have ever been treated for tuberculosis (T

מאפייני מוצר

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FLIXOTIDE DISKUS 100 MCG
FLIXOTIDE DISKUS 250 MCG
FLIXOTIDE DISKUS 500 MCG
1. NAME OF THE MEDICINAL PRODUCT
Flixotide Diskus 100 mcg
Flixotide Diskus 250 mcg
Flixotide
Diskus 500 mcg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each blister each contains
, 100
micrograms fluticasone propionate.
Excipients: Each blister contains 11.9mg lactose (as monohydrate)
Each blister each contains
,250
micrograms fluticasone propionate.
Excipients: Each blister contains 11.6mg lactose (as monohydrate)
Each blister each contains
, 500 micrograms fluticasone propionate.
Excipients: Each blister contains 11.
4mg
lactose (as monohydrate)
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Inhalation powder, pre-dispensed
Fine, white to off-white powder.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Flixotide diskus 100, 250, 500 mcg are indicated for the Prophylactic
management of all grades of
ASTHMA.
Flixotide diskus 250 mcg and 500 mcg are also indicated for the
management
of
CHRONIC OBSTRUCTIVE
PULMONARY DISEASE (COPD
) when used in combination with long-acting bronchodilators (e.g.
long-acting
beta agonists (LABAs)).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Flixotide Diskus is for inhalation by oral inhalation only.
_ _
Patients should be made aware of the prophylactic nature of therapy
with inhaled fluticasone propionate and
that it should be taken regularly even when they are asymptomatic.
The dosage of fluticasone propionate should be adjusted according to
the individual response.
ASTHMA
The onset of therapeutic effect is 4 to 7 days, although some benefit
may be apparent as soon as 24 hours for
patients who have not previously received inhaled steroids.
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If patients find that relief with short-acting bronchodilator
treatment becomes less effective or they need more
inhalations than usual, medical attention must be sought.
Adults and children over 16 years of age:-
100 to 1000 micrograms twice daily.
Patients should be given a starting dose of inhaled fluticasone
propio