AZOPT 1%

Land: Israel

Sprog: engelsk

Kilde: Ministry of Health

Aktiv bestanddel:

BRINZOLAMIDE

Tilgængelig fra:

NOVARTIS ISRAEL LTD

ATC-kode:

S01EC04

Lægemiddelform:

OPHTHALMIC SUSPENSION

Sammensætning:

BRINZOLAMIDE 1 %

Indgivelsesvej:

OCULAR

Recept type:

Required

Fremstillet af:

ALCON COUVREUR, BELGIUM

Terapeutisk gruppe:

BRINZOLAMIDE

Terapeutisk område:

BRINZOLAMIDE

Terapeutiske indikationer:

Alcon Azopt is indicated to decrease elevated intraocular pressure in: ocular hypertension open-angle glaucoma as monotherapy in patients unresponsive to beta-blockers or in patients in whom beta-blockers are contra-indicated or as adjunctive therapy to beta-blockers.

Autorisation dato:

2014-09-30

Indlægsseddel

عضو زوجي لا .ئفادلا ءاملاب نيعلا لسغإ
،_ربكأ _
_ً_
_ايئاود _
_ً_
_ارادقم أطخلاب تلمعتسإ اذإ_
.يلاتلا يئاودلا رادقملا لامعتسإ دنع
لاإ
ً
ايفاضإ
ً
ايئاود
ً
ارادقم
ىلإ
ً
اروف هجوت ،ءاودلا نم أطخلاب لفط علب
اذإ وأ
ً
اطرفم
ً
ايئاود
ً
ارادقم تلمعتسإ اذإ
.كعم ءاودلا ةبلع رضحأو ىفشتسملا يف
ئراوطلا ةفرغ ىلإ وأ بيبطلا
روف ةدحاو ةرطق طيقنت بجي ،ددح
ُ
ملا تقولا يف _ءاودلا لامعتسإ تيسن اذإ_
ً
افعاضم
ً
ايئاود
ً
ارادقم لامعتسإ زوجي لا .يدايتعلإا
ماظنلل ةدوعلا مث نمو كركذت
.يسنملا يئاودلا رادقملا نع ضيوعتلل
نيب لقلأا ىلع قئاقد 5 راظتنلإا بجي ،رخآ
عون نم نينيع تارطق لمعتست تنك اذإ
يف نويعلا مهارم مدختسإ .ىرخأ نينيع
تارطق لامعتسإو ءاودلا اذه لامعتسإ
.بيبطلا هب ىصوأ امك جلاعلا ىلع
ةبظاوملا بجي
.ةياهنلا
لبق ءاودلاب جلاعلا نع فقوتلا زوجي لا
،ةيحصلا كتلاح ىلع نسحت أرط اذإ ىتح
.بيبطلا ةراشتسإ
نيعلا لخاد طغضلا نإف _،بيبطلا ةراشتسإ
نودب ءاودلا لامعتسإ نع تفقوت اذإ_
.رصبلا نادقف ىلإ كلذ يدؤي دقو مظتني نل
_ نم دكأتلاو ءاودلا عباط صيخشت بجي
!ةمتعلا يف ةيودأ لامعتسإ زوجي لا_
_ تنك نإ تاراظنلا عضوب مق .ءاودلا اهيف
لمعتست ةرم لك يف يئاودلا رادقملا_
_.كلذل ةجاحب_
_ وأ بيبطلا رشتسإ ،ءاودلا لامعتسإب
قلعتت ةيفاضإ ةلئسأ كيدل ترفوت اذإ_
_.يلديصلا_
_ةيبناجلا ضارعلأا )4_

Produktets egenskaber

AZO API JUL 22 V5
1.
NAME OF THE MEDICINAL PRODUCT
Azopt 1% ophthalmic suspension.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of suspension contains 10 mg brinzolamide.
Excipient with known effect:
Each ml of suspension contains 0.1 mg benzalkonium chloride.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Eye drops, suspension.
White to off-white suspension.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Azopt 1% is indicated to decrease elevated intraocular pressure in:
•
ocular hypertension
•
open-angle glaucoma
as monotherapy in patients unresponsive to beta-blockers or in
patients in whom beta-blockers are
contraindicated, or as adjunctive therapy to beta-blockers (see also
section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
When used as monotherapy or adjunctive therapy, the dose is one drop
of Azopt 1% in the conjunctival
sac of the affected eye(s) twice daily. Some patients may have a
better response with one drop three times
a day.
_Special populations _
_ _
_Elderly population _
No dose adjustment in elderly patients is necessary.
_Hepatic and renal impairment _
Azopt 1% has not been studied in patients with hepatic impairment and
is therefore not recommended
in such patients.
Azopt 1% has not been studied in patients with severe renal impairment
(creatinine clearance ˂ 30 ml/min) or in
AZO API JUL 22 V5
patients with hyperchloraemic acidosis. Since brinzolamide and its
main metabolite are excreted predominantly by
the kidney, Azopt 1% is therefore contra-indicated in such patients
(see also section 4.3).
_Paediatric population _
The safety and efficacy of Azopt 1% in infants, children and
adolescents aged 0 to 17 years have not
been established. Currently available data are described in sections
4.8 and 5.1. Azopt 1% is not
recommended for use in infants, children and adolescents.
Method of administration
_ _
For ocular use.
Nasolacrimal occlusion or gently closing the eyelid after instillation
is recommended. This may reduce
the systemic absorption