Budesonide/Kleva Nasal Spray Suspension 2mg/ml

Pajjiż: Malta

Lingwa: Ingliż

Sors: Medicines Authority

Ingredjent attiv:

BUDESONIDE

Disponibbli minn:

Kleva S.A. 189 Parnithos Avenue, 13671 Acharnai, Attiki, Greece

Kodiċi ATC:

R01AD05

INN (Isem Internazzjonali):

BUDESONIDE 100 µg

Għamla farmaċewtika:

NASAL SPRAY, SUSPENSION

Kompożizzjoni:

BUDESONIDE 100 µg

Tip ta 'preskrizzjoni:

POM

Żona terapewtika:

NASAL PREPARATIONS

L-istatus ta 'awtorizzazzjoni:

Authorised

Data ta 'l-awtorizzazzjoni:

2006-06-05

Fuljett ta 'informazzjoni

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LEAFLET
1
08/11/2016
KLEVA
GR/M )
ΠΡΟΪΟΝ: Budesonide-Kleva
0
1
60
041272/001/01.11.2016
140 x 28 mm
40 x 30 mm
gr
2
COMPOSITION :
PHARMACEUTICAL FORM :
STRENGTH :
PRESENTATION - PACKAGING
THERAPEUTIC CATEGORY:
THE INFORMATION OF THIS LEAFLET REFERS ONLY TO THE PRODUCT PRESCRIBED
BY YOUR PHYSICIAN: BUDESONIDE/KLEVA .
PLEASE READ IT CAREFULLY.
IT PROVIDES IMPORTANT INFORMATION BUT IT DOES NOT EXPLAIN EVERYTHING.
IF YOU NEED MORE INFORMATION ASK YOUR PHARMACIST OR YOUR
PHYSICIAN.
GENERAL INFORMATION :
PHARMACODYNAMIC PROPERTIES
PHARMACOKINETIC PROPERTIES
INDICATIONS :
CONTRA-INDICATIONS :
PRECAUTIONS :
DRUG INTERACTIONS :
,
,
DOSAGE AND ADMINISTRATION:
_Active ingredient_
_Excipients_
_Drugs can cure, but can also create problems when are not taken as
prescribed by Physicians_
_Moreover during Budesonide/Kleva treatment the general precautions of
all corticosteroids should be taken into consideration :_
_Long-term therapy with corticosteroids leads, as already mentioned,
to HPA axis suppression. The rate of this suppression depends of_
_the dose, strength, frequency and time of administration during 24
hours of the corticosteroid drug as well as of the half-life of the
drug_
_in the tissues and the whole duration of the therapy. The dose is
adjusted according to the disease exacerbation or suppression, the_
_individual patient response to the therapy and his exposition to
emotional or physical stress (diseases, operations, trauma etc.)._
_Before using this medicine please inform your_
_Phys

Karatteristiċi tal-prodott

Page 1 of 12
1.
NAME OF THE MEDICINAL PRODUCT
BUDESONIDE/KLEVA
®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Budesonide 2 mg /ml (100 μg/dose)
Budesonide
C
25
H
34
O
6
16a,17a - butylidenedioxy - 11β, 21- dixydroxypregna - 1, 4 - diene -
3, 20 dione.
3.
PHARMACEUTICAL FORM
Metered dose nasal spray (suspension).
4.
CLINICAL DATA
4.1.
INDICATIONS
BUDESONIDE/KLEVA
®
nasal spray is indicated :
-
For the treatment of seasonal or chronic allergic rhinitis in adults
and children
(≥6 years old) and chronic non allergic rhinitis in adults.
-
For the treatment of nasal obstruction related to nasal polyps in
adults.
4.2
POSOLOGY AND METHOD ADMINISTRATION
ADMINISTRATION
For nasal use.
Page 2 of 12
DOSAGE :
The dosage of BUDESONIDE/KLEVA
®
should be individualised and limited to the
lowest possible dosage necessary for controlling the symptoms.
For method of administration see 6.6.
_SYMPTOMATIC TREATMENT OF SEASONAL OR CHRONIC ALLERGIC RHINITIS_ :
Adults, elderly and children over 6 years of age :
The recommended initial dose is 200-400 mcg daily. BUDESONIDE/KLEVA
®
may
be given once daily or may be divided in two doses in the morning and
in the
evening:
200 MCG (2 APPLICATIONS X 100 MCG) INTO EACH NOSTRIL IN THE MORNING
OR
100 MCG ( 1 APPLICATION X 100 MCG) INTO EACH NOSTRIL TWICE DAILY, IN
THE MORNING
AND IN THE EVENING.
BUDESONIDE/KLEVA
®
should not be administered for more than twice daily.
There is no data on BUDESONIDE/KLEVA
®
administration for this indication in
children younger than 6 years of age, therefore it should not be
administered in this
category of patients.
When good effect has been achieved, usually in 1-2 weeks, the dosage
should be
reduced to the minimum required for controlling the symptoms.
Treatment of seasonal rhinitis should, if possible, start before
exposure to the
allergens. Concomitant treatment may sometimes be necessary to
counteract eye
symptoms caused by the allergy.
_SYMPTOMATIC TREATMENT OF CHRONIC NON ALLERGIC RHINITIS ONLY IN
ADULTS_:
The
recommended
dose
is
mentioned
above.
BU