SEEBRI BREEZHALER 50 MCG

Χώρα: Ισραήλ

Γλώσσα: Αγγλικά

Πηγή: Ministry of Health

Δραστική ουσία:

GLYCOPYRRONIUM AS BROMIDE

Διαθέσιμο από:

NOVARTIS ISRAEL LTD

Φαρμακολογική κατηγορία (ATC):

A03AB02

Φαρμακοτεχνική μορφή:

INHALATION POWDER HARD CAPSULES

Σύνθεση:

GLYCOPYRRONIUM AS BROMIDE 50 MCG

Οδός χορήγησης:

INHALATION

Τρόπος διάθεσης:

Required

Κατασκευάζεται από:

NOVARTIS PHARMA STEIN AG, SWITZERLAND

Θεραπευτική περιοχή:

GLYCOPYRRONIUM

Θεραπευτικές ενδείξεις:

Maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).

Ημερομηνία της άδειας:

2017-12-31

Φύλλο οδηγιών χρήσης

رلاهزيرب يربيس ةقشنم لامعتسإ تاميلعت
.رلاهزيرب يربيس لامعتسإ لبق ةلماكلا
لامعتسلإا تاميلعت ةءارق ءاجرلا
ةلوسبكلا غارف نم دكأت
قمعب قشنتسإ
ررحو بقثإ
لخدأ
ةغراف ةلوسبكلا نأ نم دكأت
قوحسم ىقبت اذإ اميف ةيؤرل ةقشنملا حتفإ
.ةلوسبكلا لخادب
:ةلوسبكلا لخادب قوحسم ىقبت اذإ
ةقشنملا قلغأ
-
.ج 3 ىتح أ 3 لحارملا دواع -
قوحسم ىقبت
ةغراف
:أ 3 ةلحرملا
مات لكشب
ً
اجراخ رفزلاب مق
.ةقشنملا لخادل رفزلا زوجي لا
:أ 2 ةلحرملا
ةدحاو ةرم ةلوسبكلا بقثب مق
.يدومع عضوب ةقشنملا كسما
ىلع طغضلا ةطساوب ةلوسبكلا بقثب مق
نم .ةدشب تقولا سفنب نييبناجلا نيرزلا
بقث
ُ
ت امدنع جيجض عمست نأ ضرتفملا
.ةلوسبكلا
.طقف ةدحاو ةرم ةلوسبكلا بقثب مق
:أ 1 ةلحرملا
ىلعلأا هاجتإب ءاطغلا بحسإ
ةغرافلا ةلوسبكلا جرخأ
ةمامقلا يف ةغرافلا ةلوسبكلا يمرب مق
.ةيلزنملا
.هناكم ىلإ ءاطغلا دعأو ةقشنملا قلغأ
:ب 3 ةلحرملا
ً
اقيمع ءاودلا قاشنتسإب مق
.ةروصلاب حضوم وه امك ةقشنملا كسمإ
نم كيتفش قبطأو مفلا لخادب ةهوفلا عض
.ماكحإب اهلوح
.نييبناجلا نيرزلا ىلع طغضلا زوجي لا
.نكمأ ام
ً
اقيمع ،ةعرسب لخادلا ىلإ قشنتسإ
.ةشخشخ توص عمستس قاشنتسلإا للاخ
للاخ ءاودلا معطب رعشت نأ زئاجلا نم
.قاشنتسلإا
:ب 2 ةلحرملا
نييبناجلا نيرزلا ررح
:ب 1 ةلحرملا
ةقشنملا حتفإ
ةماه تامولعم
رلاهزيرب يربيس تلاوسبك نيزخت
ً
امئاد ب

Αρχείο Π.Χ.Π.

SEE API FEB22 V2
REF EU SmPC Nov2021
Business Use Only
Page
1
of
16
_ _
1.
NAME OF THE MEDICINAL PRODUCT
Seebri® Breezhaler® 50 micrograms inhalation powder, hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 63 micrograms of glycopyrronium bromide
equivalent to 50 micrograms of
glycopyrronium.
Each delivered dose (the dose that leaves the mouthpiece of the
inhaler) contains 55 micrograms of
glycopyrronium bromide equivalent to 44 micrograms of glycopyrronium.
Excipient(s) with known effect:
Each capsule contains 23.6 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
_ _
3.
PHARMACEUTICAL FORM
Inhalation powder, hard capsule (inhalation powder).
Transparent orange capsules containing a white powder, with the
product code “GPL50” printed in
black above and the company logo (
) printed in black below a black radial bar.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Maintenance bronchodilator treatment to relieve symptoms in adult
patients with chronic obstructive
pulmonary disease (COPD).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is the inhalation of the content of one capsule
once daily using the Seebri
Breezhaler inhaler.
Seebri Breezhaler is recommended to be administered, at the same time
of the day each day. If a dose
is missed, the next dose should be taken as soon as possible. Patients
should be instructed not to take
more than one dose in a day.
SEE API FEB22 V2
REF EU SmPC Nov2021
Business Use Only
Page
2
of
16
Special populations
_ _
_Elderly population _
Seebri Breezhaler can be used at the recommended dose in elderly
patients (75 years of age and older)
(see section 4.8).
_ _
_Renal impairment _
Seebri Breezhaler can be used at the recommended dose in patients with
mild to moderate renal
impairment. In patients with severe renal impairment or end-stage
renal disease requiring dialysis
Seebri Breezhaler should be used only if the expected benefit
outweighs the potential risk since the
systemic exposure to