ENERZAIR BREEZHALER 114 MCG46 MCG136 MCG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

GLYCOPYRRONIUM AS BROMIDE; INDACATEROL AS ACETATE; MOMETASONE FUROATE

Available from:

NOVARTIS ISRAEL LTD

ATC code:

R01AD09

Pharmaceutical form:

HARD CAPSULE

Composition:

MOMETASONE FUROATE 160 MCG; GLYCOPYRRONIUM AS BROMIDE 50 MCG; INDACATEROL AS ACETATE 150 MCG

Administration route:

INHALATION

Prescription type:

Required

Manufactured by:

NOVARTIS PHARMA STEIN AG, SWITZERLAND

Therapeutic area:

MOMETASONE

Therapeutic indications:

Enerzair Breezhaler is indicated as a maintenance treatment of asthma in adult patients not adequately controlled with a maintenance combination of a long-acting beta2-agonist and an inhaled corticosteroid who experienced one or more asthma exacerbations in the previous year.Important Limitations of Use:Enerzair Breezhaler is not indicated in patients with COPD.

Authorization date:

2021-12-21

Patient Information leaflet

رلاهزيرب ر
ِ
ئزرينإ لامعتسإ تاميلعت
.رلاهزيرب ر
ِ
ئزرينإ لامعتسإ لبق ةلماكلا لامعتسلإا
تاميلعت ةءارق ءاجرلا
ةلوسبكلا غارف نم دكأت
قمعب قشنتسإ
ررحو بقثأ
لخدأ
ةغراف ةلوسبكلا نأ نم دكأت
.ةلوسبكلا لخاد قوحسم ىقبت اذإ اميف
ةيؤرل ةقشنملا حتفإ
:ةلوسبكلا لخاد قوحسم ىقبت اذإ
ةقشنملا قلغأ
●
.د3 ىتح أ3 لحارملا ررك ●
قوحسم ىقبت ةغراف
:أ3 ةلحرملا
لماك لكشب جراخلل رفزأ
.ةقشنملا لخاد رفزلا زوجي لا
:أ2 ةلحرملا
ةدحاو ةرم ةلوسبكلا بقثأ
.يدوماع عضوب ةقشنملا كسمأ
نم .تقولا سفن يف نيبناجلا نيرزلا ىلع
ةدشب طغضلاب ةلوسبكلا بقثأ
.ةلوسبكلا بقث
ُ
ت امدنع جيجض عمست نأ ضرتفملا
.طقف ةدحاو ةرم ةلوسبكلا بقثأ
:أ1 ةلحرملا
ىلعلأا وحن ءاطغلا بحسإ
ةغرافلا ةلوسبكلا جرخأ
.ةيلزنملا ةمامقلا يف ةغرافلا ةلوسبكلا
ِ
مرإ
.هناكم ىلإ ءاطغلا دعأو ةقشنملا قلغأ
:ب3 ةلحرملا
قمعب ءاودلا قشنتسإ
.ةروصلا يف حضوم وه امك ةقشنملا كسمأ
.ماكحإب اهلوح نم كيتفش قبطأو مفلا لخاد
ةهوفلا عض
.نييبناجلا نيرزلا ىلع طغضلا زوجي لا
.نكمأ ام
ً
اقيمع ،ةعرسب لخادلا ىلإ قشنتسإ
.ةشخشخ توص عمستس قاشنتسلإا للاخ
.قاشنتسلإا للاخ ءاودلا معطب رعشت دق
:ب2 ةلحرملا
نييبناجلا نيرزلا ررح
:ب1 ةلحرملا
ةقشنملا حتفإ
ةماه تامولعم
اهجارخإو ةحيوللا لخاد رلاهزيرب ر
ِ
ئزرينإ تلاوسبك نيزخت
ً
امئاد بجي
-
.ةرشابم لامع�

Summary of Product characteristics

ENE API JUL22 V2.1
Australian PI Dec2021
Business Use Only
1
NAME OF THE MEDICINAL PRODUCT
Enerzair Breezhaler 114 mcg/46 mcg/136 mcg
Inhalation powder hard capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Enerzair Breezhaler hard capsules are for oral inhalation only. They
are also supplied with an Enerzair
Breezhaler inhalation device to permit oral inhalation of the contents
of the capsule shell.
Each capsule contains 173 micrograms of indacaterol acetate equivalent
to 150 micrograms of
indacaterol, 63 micrograms of glycopyrronium bromide (glycopyrrolate)
equivalent to 50 micrograms
glycopyrronium and 160 micrograms mometasone furoate.
The delivered dose (the dose that leaves the mouthpiece of the
inhaler) for 114/46/136 micrograms
is equivalent to 114 micrograms indacaterol, 46 micrograms
glycopyrronium, and 136 micrograms
mometasone furoate.
EXCIPIENTS WITH KNOWN EFFECT
Each capsule contains approximately 25 mg lactose (as monohydrate).
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Inhalation powder, hard capsule
Capsules with green transparent cap and uncoloured transparent body
containing a white to
practically white powder, with the product code “IGM150-50-160”
printed in black above two black
bars on the body and with a logo printed in black and surrounded by
one black bar on the cap.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Enerzair Breezhaler is indicated as a maintenance treatment of asthma
in adult patients not
adequately controlled with a maintenance combination of a long-acting
beta
2
-agonist and an inhaled
corticosteroid who experienced one or more asthma exacerbations in the
previous year.
Important Limitations of Use:
Enerzair Breezhaler is not indicated in patients with COPD.
ENE API JUL22 V2.1
Australian PI Dec2021
Business Use Only
4.2
POSOLOGY
AND
METHOD
OF
ADMINISTRATION
POSOLOGY
Treatment must be initiated and supervised by physicians experienced
in the treatment of asthma. _ _
_Adult patients _
Inhalation of the content of on