NASOCORT AQUA 64 MCGDOSE
Țară: Israel
Limbă: engleză
Sursă: Ministry of Health
Prospect
(PIL)
17-08-2016
Caracteristicilor produsului
(SPC)
17-08-2016
Ingredient activ:
BUDESONIDE MICRONIZED
Disponibil de la:
ASTRA ZENECA (ISRAEL) LTD
Codul ATC:
A07EA06
Forma farmaceutică:
NASAL SPRAY
Compoziție:
BUDESONIDE MICRONIZED 1.28 MG/ML
Calea de administrare:
NASAL
Tip de prescriptie medicala:
Required
Produs de:
ASTRA ZENECA AB., SWEDEN
Grupul Terapeutică:
BUDESONIDE
Zonă Terapeutică:
BUDESONIDE
Indicații terapeutice:
Seasonal and perennial allergic rhinitis, and vasomotor rhinitis. Preventively against nasal polyps after polypectomy. Symptomatic treatment in nasal polyposis.
Data de autorizare:
2012-08-31
Prospect
308111-A02
23-08-11
6804766.59
AZL010/A
5361
Nasocort 64mcg Leaflet: Patient IL
Black
. نينس ٦ رمع نود لافطلأل ةداع ص
ّ
صخم ريغ ءاودلا اذه
تاميلعت بسح ةددحم تاقوأ يف ءاودلا اذه
لامعتسا بجي
. جلاعملا بيبطلا
بجيف ،نيعملا تقولا
يف يئاودلا رادقملا لامعتسا تيسن اذا
اًعم نيرادقم لامعتسا زوجي لا نكلو !
كركذت لاح هلامعتسا
.لاوحلأا نم لاح يأ يف
رورم دعب طقف لماكلا ءاودلا ريثأت ىلإ
لصوتلا متي : ةظحلام
.مايأ ةدع
:لامعتسلاا تاداشرا
.
خاخبلا لامعتسإ لبق ناعمإب ةقحلملا
لامعتسلإا تاميلعت
ي
/
أرقإ ؟جلاعلا حاجن يف ي / مهاست نأ ني / عيطتست
فيك
. بيبطلا لبق نم هب ىصوملا جلاعلا لامكا
بجي
نم تاميلعت نودب ءاودلا اذه لامعتسا نع
ي / فقوتت لا
. ةيحصلا كتلاح ىلع نسحت أرط ولو ىتح
بيبطلا
! ممستلا ي / بنجت
لوانتم نع
اًديعب قلغم ناكم
يف ءاود لكو ءاودلا اذه ظفح بجي
.
ممستلاب مهتباصا
يدافتل كلذو
،عضرلا وأ/و لافطلأا
يديأ
علب اذا وأ ةيئاودلا ريداقملا لامعتسا
يف تطرفأ اذا
ىفشتسملا ىلا هجوتلا كيلع ،ءاودلا اذه
نم أطخ ة/لفطلا
. ءاودلا ةوبع ة / اًبحطصم
ً
لااح
! بيبطلا نم ةحيرص تاميلعت نودب ؤيقتلا ي
/ ببست لا
. رخآ ضيرمل ررضلا ببسي دقو ،كضرم جلاعل
فصو ءاودلا اذه
. كفراعم وأ كناريج ،كبراقأ ىلا
ءاودلا نم
ي / طعت لا
ءاودلا عباط صيخشت بجي !ةمتعلا يف
ءاودلا ي / لوانتت لا
اهيف ني / لوانتت ةرم لك يف ةيئاودلا
ريداقملا نم
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Caracteristicilor produsului
1 (6)
“This leaflet format has been determined by the Ministry of Health
and the content thereof has been
checked and approved in March 2011”
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
NASOCORT
®
AQUA
32 AND 64
G/DOSE
_Budesonide micronized _
NASAL SPRAY
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Budesonide 1.28 mg/ml (64 micrograms/dose).
Budesonide 0.64 mg/ml (32 micrograms/dose).
One dose (0.05 ml) contains budesonide 32 micrograms or 64 micrograms.
For excipients, see 6.1.
3.
PHARMACEUTICAL FORM
Nasal spray
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Seasonal and perennial allergic rhinitis, and vasomotor rhinitis.
Preventively against
nasal polyps after polypectomy. Symptomatic treatment in nasal
polyposis.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The posology must be adjusted individually.
_Rhinitis_
Adults
and
children
over
6
years
of
age:
The
recommended
initial
dose
is
256 micrograms daily. The dose can be administered once daily in the
morning, or
divided
into
two
administrations,
morning
and
evening,
i.e.
128
micrograms
(2 x 64 micrograms) into each nostril in the morning or 64 micrograms
into each
nostril morning and evening.
No further effect has been shown for daily doses higher than 256
micrograms
.
For elderly patients the posology is the same as for adults.
2 (6)
When the desired effect has been obtained, the dose is reduced to the
lowest amount
necessary for control of the symptoms.
Clinical trials show that a dose of 32 micrograms into each nostril in
the morning may
be sufficient for some patients.
Symptomatic relief occurs in some patients within only 5-7 hours after
the start of
treatment. The full effect is only obtained after a few days of
treatment (in rare cases
not until after 2 weeks). Treatment of seasonal rhinitis should
therefore, if possible,
start before exposure to the allergens.
In cases of severe nasal congestion the adjunct of a vasoconstrictor
may be required.
Supplementary treatment may sometimes be necessary in order to
counteract
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