PRIZMA SOLUTION

Χώρα: Ισραήλ

Γλώσσα: Αγγλικά

Πηγή: Ministry of Health

Δραστική ουσία:

FLUOXETINE AS HYDROCHLORIDE

Διαθέσιμο από:

UNIPHARM LTD, ISRAEL

Φαρμακολογική κατηγορία (ATC):

N06AB03

Φαρμακοτεχνική μορφή:

SOLUTION (ORAL)

Σύνθεση:

FLUOXETINE AS HYDROCHLORIDE 4 MG/ML

Οδός χορήγησης:

PER OS

Τρόπος διάθεσης:

Required

Κατασκευάζεται από:

UNIPHARM LTD, ISRAEL

Θεραπευτική περιοχή:

FLUOXETINE

Θεραπευτικές ενδείξεις:

Adults:Major depressive episodes.Obsessive-compulsive disorder (OCD).Bulimia nervosa: Fluoxetine is indicated as a complement of psychotherapy for the reduction of binge-eating and purging activity.Children and adolescents aged 8 years and above:Moderate to severe major depressive episode, if depression is unresponsive to psychological therapy after 4-6 sessions. Antidepressant medication should be offered to a child or young person with moderate to severe depression only in combination with a concurrent psychological therapy.

Ημερομηνία της άδειας:

2019-11-27

Φύλλο οδηγιών χρήσης

ثلثلا يف ةصاخو لمحلا للاخ )
Fluoxetine
( نيتيسكوأولف لثم ةيودأ لوانت نإ
دولوملا ىدل روطتت دق يتلا ةريطخ تلااح
روهظ ةروطخ نم ديزي ،لمحلل ريخلأا
عيضرلل ببسي يذلا )PPHN( نينجلا ىدل يوئرلا
مدلا طغض عافترإ ةامسملا
.نوللا قرزأ ودبي نأو عرسأ لكشب سفنتلا
.ةدلاولا دعب ىلولأا ةعاس 24 ـلا للاخ
ةداع رهظت ضارعلأا هذه
ةحصل ةقلق تنك اذإ وأ ،كعيضر ىدل
ضارعلأا كلت نم ضرع يأ روهظ لاح يف
.بيبطلا ىلا
ً
لااح هجوتلا كيلع ،كعيضر
لامعتسلإا نم ةدئافلا تناك اذإ لاإ
لمحلا للاخ لولحم امزيرﭘ لامعتسإ مدع
لضف
ُ
ي
نع فقوتلاب ريرقتلا كبيبطو تنأ كيلع
،كلذل .هلامعتساب ةطونملا رطاخملا نع
ديزت
.لمحلل نيططخت امدنع وأ لماح ينوكت
امدنع يجيردت لكشب لولحم امزيرﭘ
لامعتسإ
ةريخلأا رهشلأا يف ةصاخ ،لمحلا للاخ
ءاودلا لامعتسإ دنع رذحب فرصتلا بجي
عضرلا ىدل ةيلاتلا ضارعلأا ثودح نع غلب
هنلأ كلذو ةدلاولا لبقو لمحلا نم
تابوعصو رمتسم ءاكب ،تلاضعلا فعض
،نافجر/ةريرعشق ،جايه :ةدلاولا يثيدح
.مونلا يفو ةعاضرلا يف
كلانه نوكت دقف ،لمحلا ةرتف ةياهن نم
ً
ابيرق لولحم امزيرﭘ نيلمعتست تنك اذإ
تدجو اذإ ةصاخ ،ةدلاولا دعب ةريصق ةدمل
ديدش يلبهم فزن ثودحل ربكأ ةروطخ
نوكي يكل لولحم امزيرﭘ نيلمعتست كنأب
بيبطلا غلابإ كيلع .ةفزنلأ ةقباس كيدل
.كل ةراشتسلإا ميدقت هناكمإب
ىلع رثؤي دقو ملأا بيلح يف �

Αρχείο Π.Χ.Π.

Prizma Solution
20mg per 5ml oral solution
1. Name of the medicinal product
Prizma Solution
20mg per 5ml
oral solution.
2. Qualitative and quantitative composition
Each 5 ml of oral solution contains 20 mg of fluoxetine (as fluoxetine
hydrochloride).
Excipients with known effect: contains 3 g of sucrose per 5 ml dose.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
The solution is clear, colorless to yellowish.
4. Clinical particulars
4.1 Therapeutic indications
Adults:
Major depressive episodes.
Obsessive-compulsive disorder (OCD).
Bulimia nervosa: Fluoxetine is indicated as a complement of
psychotherapy for the reduction of
binge-eating and purging activity.
Children and adolescents aged 8 years and above:
Moderate to severe major depressive episode, if depression is
unresponsive to psychological therapy
after 4–6 sessions. Antidepressant medication should be offered to a
child or young person with
moderate to severe depression only in combination with a concurrent
psychological therapy.
4.2 Posology and method of administration
Adults:
Major Depressive Disorder
_Initial Treatment _
In controlled trials used to support the efficacy of fluoxetine,
patients were administered morning
doses ranging from 20 to 80 mg/day. Studies comparing fluoxetine 20,
40, and 60 mg/day to placebo
indicate that 20 mg/day is sufficient to obtain a satisfactory
response in Major Depressive Disorder in
most cases. Consequently, a dose of 20 mg/day, administered in the
morning, is recommended as
the initial dose.
A dose increase may be considered after several weeks if insufficient
clinical improvement is
observed. Doses above 20 mg/day may be administered on a once-a-day
(morning) or BID schedule
(i.e., morning and noon) and should not exceed a maximum dose of 80
mg/day.
_All patients_ — As with other drugs effective in the treatment of
Major Depressive Disorder, the full
effect may be delayed until 4 weeks of treatment or longer.
Patients with depression should be treated for a sufficient period of
at lea